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Statistical analysis | SECONDARY | A previous study showed a 6.5% mean risk of an AF episode during a 1-day period and 16.7% mean risk of at least one AF episode during a 7-day period [Efficacy analysis was conducted on the full analysis set (FAS), which included all patients who met the inclusion criteria but not the exclusion criteria. Patients who did not wear their assigned device after randomization and those for whom no data were available after randomization were excluded from the FAS. We used an exact McNemar’s test in the main analysis of the primary endpoint. In other analyses of the primary endpoint, the detection rate and exact confidence interval (CI) were calculated for each device. For the secondary endpoints, we applied the same analysis to binary variables as to the primary endpoint. Descriptive statistics (mean, standard deviation, median, and interquartile range) were calculated for frequency variables in both groups, and the Wilcoxon rank sum test was used to compare the groups. The significance level of the statistical test was set at 0.05, and a two-sided test was performed. The confidence interval was set at 95%. In dropouts, statistical tests were conducted for binary variables (yes/no) by imputing “No” if the data were missing for both devices or for one device and “No” for the other device, and by imputing “Yes” if the data were “Yes” for one device and missing for the other device. Imputation and modeling for missing values were not implemented for other analyses.The safety analysis population included all patients except those for whom no data were available after randomization. The same analysis was performed as for the primary endpoint.All analyses were performed using SAS ver. 9.4 (SAS Institute Inc., Cary, NC, USA). | PMC9955627 |
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Results | Patients were registered at the University of Tsukuba Hospital from August 2018 to December 2019. The follow-up period ended in April 2020. | PMC9955627 |
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Study population | Of the 72 patients who consented to participate, 67 completed the study, 4 withdrew because of scheduling problems, and 1 withdrew without providing a reason. The patients were randomly assigned to group 1 (n = 35), which started the study using the Garment ECG with textile electrode for 2 weeks and then the Holter ECG with gel electrode for 24 hours, or group 2 (n = 32), which started the study by wearing the Holter monitor for 24 hours and then the Garment ECG for 2 weeks. Data yielded 67 paired ECGs (2 from each patient) from the Garment ECG for 2 weeks and the Holter ECG for 24 hours ( | PMC9955627 |
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Patient background | The mean age was 63.1±10.6 years old, and 53 (79%) were men. There were 46 patients (69%) with paroxysmal AF, 18 (27%) with persistent AF, and 3 (4%) with long-standing persistent AF. Underbust circumference averaged 92.0±9.1 cm, appropriate for the available sizes (Small, Medium, and Large) of the Garment ECG. Most patients received anticoagulation therapy, and some were taking antiarrhythmics before and 3 months after ablation ( | PMC9955627 |
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Patient characteristics. | ATRIAL FIBRILLATION | AF, atrial fibrillation; BNP, B-type natriuretic peptide; EF, ejection fraction; eGFR, estimated glomerular filtration rate; LAD, left anterior descending artery; LAVI, left atrial volume index; PVI, pulmonary vein isolation; SD, standard deviation. | PMC9955627 |
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Efficacy | RECURRENCE | The 2-week Garment ECG monitoring detected 12 patients (18%) with AF recurrence, of whom only 4 were detected by 24-hour Holter ECG (6%, p = 0.008) ( | PMC9955627 |
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AF occurrences during the follow-up period. | ATRIAL FIBRILLATION | A, AF occurrences in 12 relapsed patients. B, Data from 5 patients who had AF on the first day of Garment ECG measurements. * Of the 12 patients, 4 also showed AF on the Holter 24-hour ECG. AF, atrial fibrillation; ECG, electrocardiogram. | PMC9955627 |
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AF duration in the Garment ECG measurement period. | ATRIAL FIBRILLATION | AF, atrial fibrillation; ECG, electrocardiogram. | PMC9955627 |
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Results from questionnaire on wearability of the garment ECG device (secondary endpoint). | PACS, PREMATURE ATRIAL CONTRACTIONS | The Holter 24-hour ECG demonstrated a slightly higher frequency of premature atrial contractions (PACs) than the 2-week Garment ECG (0.09% [IQR 0.03–0.48%] versus 0.09% [0.03–0.33%], p = 0.014) ( | PMC9955627 |
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Safety | redness, erosion | ADVERSE EVENTS, EROSION, SCAR | There were no serious adverse events or unexpected adverse events with either monitoring system. The expected effects on the skin were: redness (n = 2, 3%), erosion (n = 0, 0%), and scar (n = 0, 0%) for 2-week Garment ECG; and redness (n = 0, 0%), erosion (n = 0, 0%), and scar (n = 0, 0%) for 24-hour Holter ECG. | PMC9955627 |
Discussion | skin irritation, AF | EVENTS, RECURRENCE, PACS | A Garment ECG using hitoeLong-term ECG monitoring options for AF are being explored using implantable devices and non-invasive external recorders. However, implantable devices are expensive and not covered by health insurance, and non-invasive recorders often provide false positives or are otherwise unreliable [In the present study the ECG acquisition rate for the Garment ECG was 82.4%, with noise accounting for the difference between the actual acquisition rate and 100.0%. However, even at this noise level, results from our study support the clinical usefulness of this 2-week wearable system. Because the system is constructed in the form of a garment, there are some concerns that the electrode might shift with body movement, which could increase noise. Our pilot study showed a slightly higher ratio of noise signals than for the 24-hour Holter ECG, but the noise signals did not affect heart rate and were thus considered not to be clinically important [Garment ECG monitoring showed evidence of AF recurrence among 12 patients at non-uniform intervals during the 2 weeks of monitoring, including 1 patient whose first recurrence occurred at the very end of the monitoring period. This suggests that AF recurrence may be underdiagnosed by Holter ECG monitoring for two reasons: because post-ablation AF occurs only rarely in some patients, and also because the timing of those occurrences is highly non-uniform. In addition, 8 of 12 patients were asymptomatic in this study, supporting previous findings that post-ablation AF recurrence is frequently asymptomatic and can only be diagnosed from ECG recordings [The incidence of AF may vary depending on the patient population, and long-term monitoring will be especially beneficial in patients with lower AF incidence. The Garment ECG can support even more prolonged monitoring in the future by providing improved longer-term data storage and higher-capacity batteries while continuing to eliminate the risk of accidental patch removal. This system thus may prove more beneficial than wearable patch-type devices, not only in post-ablation patients but also in a wider population of patients who need access to this type of monitoring.Because PACs can trigger AF, we also assessed the incidence of PACs using Garment and Holter ECGs. The difference in results was statistically significant but had no clinical significance, showing the same median value of 0.09% for both devices.While patch-type ECG monitors with gel-type electrodes have been associated with mild skin irritation in some patients [One limitation of this study was the fact that, because the Garment ECG monitoring system with a dry electrode is not waterproof, AF monitoring time was interrupted when the patients removed the garment to bathe. Another limitation was the small sample size of this study, with only 12 out of 67 patients experiencing recurrent AF after ablation. Although we found a significant difference in the detection of post-ablation AF events between the 2 groups, further studies in a larger population are warranted. In assessing the risk of bias in this study [In conclusion, continuous 2-week recording with a garment-style wearable ECG monitor equipped with a textile electrode showed a higher extent of AF recurrence than with a Holter 24-hour ECG monitor. The 2-week monitoring period more than compensated for the lower acquisition rate of the Garment ECG system, revealing a higher level of hidden AF recurrence than was recorded with the Holter 24-hour ECG. | PMC9955627 |
Supporting information | PMC9955627 |
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CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file. | PMC9955627 |
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Study protocol. | (DOCX)Click here for additional data file.We thank all the patients who participated in this study and our hospital staff at the physiological laboratory. | PMC9955627 |
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Abbreviations | Atrial fibrillationconfidence intervalelectrocardiogramfull analysis setimplantable loop recorderinterquartile rangeJapan Registry of Clinical Trialspoly(3,4-ethylenedioxythiophene) poly(styrenesulfonate)ACReSS, University Hospital Clinical Trial Alliance Clinical Research Support System) | PMC9955627 |
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References | PMC9955627 |
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Background | hypertension | HYPERTENSION | This randomized controlled trial was performed to observe the effect of remimazolam with sufentanil on hemodynamics during anesthetic induction in elderly patients with mild hypertension undergoing orthopedic surgery of the lower limbs. | PMC10500846 |
Methods | bradycardia, nausea, vomiting, pain, hypotension | ADVERSE EVENTS | Sixty elderly patients were randomly assigned to undergo general anesthesia with intravenous injection of either remimazolam besylate (25 mg/vial, batch number 10T11011; Yichang Humanwell Pharmaceutical Co., Ltd., Yichang, China) at 0.2 mg/kg (Group R, n = 30) or propofol at 1.5 mg/kg (Group P, n = 30). Both injections were completed within 15 to 20 s. If the bispectral index value did not reach 40 to 60, then 0.05 mg/kg of remimazolam was added in Group P and 1 mg/kg of propofol was added in Group R. When the BIS value reached 40 to 60, sufentanil was administered at 0.3 to 0.5 µg/kg and cisatracurium was administered at 0.15 to 0.2 mg/kg in both groups. Three minutes later, tracheal intubation and controlled ventilation were performed to maintain the end-tidal carbon dioxide partial pressure at 4.5 to 5.0 kPa. The mean arterial pressure (MAP), heart rate (HR), cardiac output (CO), continuous cardiac index (CI), systemic vascular resistance (SVR), and pulse oxygen saturation were recorded before induction (T0), when the eyelash reflex disappeared (T1), immediately after endotracheal intubation (T2), 1 min after endotracheal intubation (T3), and 5 min after endotracheal intubation (T4). The disappearance time of the eyelash reflex, injection pain, hypotension, bradycardia, hiccupping, nausea and vomiting, and other adverse events were observed. | PMC10500846 |
Results | ADVERSE EVENTS, ADVERSE EVENT | The MAP, HR, CO, and CI at T1, T2, T3, and T4 were significantly higher in Group R than P, while SVR was significantly lower in Group R than P (P < 0.05). In Group P, the MAP, HR, CO, and CI were significantly lower and the SVR was significantly higher at T1, T2, T3, and T4 than at T0 (P < 0.05). Adverse events occurred in 8 (20%) patients in Group R and 22 (73%) in Group P. The total incidence of adverse events was significantly lower in Group R than P (P < 0 0.001). | PMC10500846 |
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Conclusion | ADVERSE REACTIONS, HYPERTENSION | Remimazolam combined with sufentanil for general anesthesia induction has the advantages of small hemodynamic fluctuations, stable circulation, and few adverse reactions, making it suitable for elderly patients with mild hypertension. | PMC10500846 |
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Trial registration | Chinese Clinical Trial Registry (ChiCTR2300069224, 10/03/2023). | PMC10500846 |
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Keywords | PMC10500846 |
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Background | bradycardia, arrhythmia, Hypertension, hypotension, hypertension | ARRHYTHMIA, HYPERTENSION, HYPERTENSION, COMPLICATIONS | With the aging of the population, increasing numbers of elderly patients need surgical treatment. Hypertension is very common in elderly patients. Because elderly patients with hypertension generally have poor vascular elasticity, declining cardiovascular reserve function, and weakening of compensatory ability, hemodynamic fluctuations are likely to occur during anesthetic induction in these patients, potentially inducing serious complications. Propofol is a widely used sedative drug in the clinical setting and has the advantages of a short half-life and rapid recovery. However, the use of conventional doses of propofol in elderly patients is associated with a risk of complications such as hypotension, bradycardia, and arrhythmia [Remimazolam is a new type of anesthetic that has raised widespread concern. Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic with the pharmacological properties of rapid onset, rapid recovery, and relatively small effects on hemodynamics [ | PMC10500846 |
Methods | PMC10500846 |
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Clinical data | bradycardia, mental illness, liver and kidney dysfunction, arrhythmia, hypertension | ATRIOVENTRICULAR BLOCK, HYPERTENSION, ARRHYTHMIA, ESSENTIAL HYPERTENSION | This study was approved by the Medical Ethics Committee of The Sixth Affiliated Hospital of Wenzhou Medical University in Lishui, China (LLW-FO-403) and was registered at the Chinese Clinical Trial Registry (ChiCTR2300069224, 10 March 2023). Written informed consent was obtained from all patients. All methods were carried out in accordance with relevant guidelines and regulations.After obtaining approval from the hospital’s medical ethics committee and written consent from the patients, we enrolled 60 elderly patients with mild hypertension who underwent elective orthopedic surgery of the lower limbs from August 2021 to March 2022. The selected patients met the following criteria: 65 to 75 years of age, American Society of Anesthesiologists physical status of II or III, cardiac function class I or II, and blood pressure controlled within 160/90 mmHg after standardized treatment for those with a history of essential hypertension. None of the patients had serious arrhythmia or serious liver and kidney dysfunction, and none had a history of mental illness. The exclusion criteria were hypertension without regular medical therapy, bradycardia, and second-degree or worse atrioventricular block. The patients enrolled in the study comprised 27 male and 33 female patients with an age of 65 to 80 years and body weight of 50 to 78 kg. According to the order of treatment, the patients were randomly divided into two groups of 30 patients each: remimazolam 0.2 mg/kg (Group R) and propofol 1.5 mg/kg (Group P) (Fig.
Flow of participants through the study | PMC10500846 |
Methods | EVENTS | The patients in both groups were routinely administered 10 mL/kg/h lactated Ringer’s solution in a readily accessible hand vein upon admission, and the mean arterial pressure (MAP), electrocardiogram, heart rate (HR), pulse oxygen saturation (SpOAdverse events were defined as follows [ | PMC10500846 |
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Outcomes | PMC10500846 |
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Primary outcomes | The primary outcomes of this study were the disappearance time of the eyelash reflex and the following hemodynamic indices: MAP, HR, CO, CI, and SVR. | PMC10500846 |
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Secondary outcome | bradycardia, nausea, vomiting, pain, hypotension | ADVERSE EVENTS, EVENTS, SECONDARY | The secondary outcome of this study was the incidence of adverse events, including hypotension, bradycardia, hiccupping, nausea, injection pain, and vomiting. The patients were monitored for these events from the beginning of anesthetic induction to the completion of endotracheal intubation. | PMC10500846 |
Statistical analysis | hypotension | The sample size was estimated using PASS 11 software (NCSS, LLC, Kaysville, UT, USA). In our pilot study, the incidence of hypotension elicited by 1.5 mg/kg of propofol was 40% (8/20), which was reduced to 10% (2/20) after pretreatment with 0.2 mg/kg of remimazolam. To achieve 80% (β = 0.20) statistical power with α = 0.05, each group would require no less than 23 patients. To account for drop-outs, we recruited 30 patients per group.Data processing was performed using SPSS 15.0 (SPSS Inc., Chicago, IL, USA). The normality test in SPSS was used to determine whether the data conformed to a normal distribution. Measurement data are expressed as mean ± standard deviation. Repeated-measures analysis of variance was performed for intragroup comparisons, and one-way analysis of variance was performed for intergroup comparisons. A P value of < 0.05 was considered statistically significant. | PMC10500846 |
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Results | PMC10500846 |
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Demographic characteristics | This trial was conducted from August 2021 to March 2022. Sixty eligible patients were screened and included in the final analyses. The patients’ demographic characteristics, including sex, age, and body mass index, were similar between the two groups (P > 0.05) (Table
Demographic dataValues are expressed as mean ± standard deviation or number of cases. No statistically significant differences in sex, age, or body mass index were observed between the groups. | PMC10500846 |
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Discussion | hypertension, postoperative nausea and vomiting, P. | ADVERSE EVENTS, CEREBROVASCULAR ACCIDENTS, DISEASE, HYPERTENSION, DISEASES | In this study, we demonstrated that the MAP, HR, CO, and CI at T1, T2, T3, and T4 were significantly higher in Group R than P, while SVR was significantly lower in Group R than P. The incidence of total adverse events was 73% in patients in Group P but only 20% in patients in Group R.Elderly patients’ health is often complicated by a variety of diseases, of which hypertension is the most common. Their tolerance to anesthesia and surgery is lower than that of younger patients. Severe hemodynamic fluctuations can easily induce cerebrovascular accidents. Tracheal intubation during anesthetic induction is a severely noxious stimulus and can have a severe impact on patients’ hemodynamics. Maintaining stable hemodynamics of elderly patients during induction and improving the blood perfusion of the heart, brain, kidney, and other important organs can improve the disease outcome and prognosis of elderly patients [As a commonly used anesthetic in the clinical setting, propofol has the advantages of rapid onset, short duration of action, no accumulation in the body, and minimal postoperative nausea and vomiting. Propofol is widely used in the induction and maintenance of anesthesia. It exerts its sedative and hypnotic effects through interaction with gamma-aminobutyric acid receptors and has certain cardiovascular inhibitory effects that can lead to a decrease in blood pressure, CO, and HR [Remimazolam is a new benzodiazepine drug that has the advantages of rapid recovery and metabolism, no drug accumulation, independence from liver and kidney metabolism, and few side effects [ | PMC10500846 |
Acknowledgements | We thank Angela Morben, DVM, ELS, from Liwen Bianji (Edanz) ( | PMC10500846 |
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Authors’ contributions | All authors made substantial contributions to the design of this study, data acquisition and interpretation, statistical planning, drafting of the manuscript, or critical revision of the manuscript. All authors agree to be accountable for all aspects of the work and have approved the final version of the manuscript for submission. | PMC10500846 |
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Funding | This study was supported by the Project of Zhejiang Medical Association (YS2021-1-15). The funding body had no role in the design of the study; the collection, analysis, or interpretation of the data; or the writing of the manuscript. | PMC10500846 |
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Data Availability | The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding authors. | PMC10500846 |
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Declarations | PMC10500846 |
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Ethics approval and consent to participate | This study was approved by the Medical Ethics Committee of The Sixth Affiliated Hospital of Wenzhou Medica University in Lishui, China (LLW-FO-403) and was registered at the Chinese Clinical Trial Registry (ChiCTR2300069224, 10 March 2023). It adheres to the principles outlined in the Declaration of Helsinki and the CONSORT 2010 guidelines. Informed consent regarding study enrollment and anonymized data collection and publication was obtained from all patients. | PMC10500846 |
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Consent for publication | Not applicable. | PMC10500846 |
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Competing interests | The authors declare that they have no competing interests. | PMC10500846 |
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References | PMC10500846 |
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Subject terms | cough, cord injury, tetraplegia, C-SCI | TETRAPLEGIA | This prospective pilot study investigated the influence of body position on peak cough flow (PCF) during mechanical insufflation–exsufflation (MI-E) treatment in people with tetraplegia. Fifteen participants with cervical spinal cord injury (C-SCI) were randomized into two groups, which differed in the starting position, that is, the patients were either supine or reclined. Four sessions of MI-E in alternating positions with each session comprising three different maneuvers: five voluntary coughs, five MI-E-assisted coughs, and five MI-E-assisted with manual thrusts were performed with continuous airflow measurement reporting PCF from every cough. PCF was associated with the application maneuvers, total insufflation volume (TIV), and interaction between position and maneuvers but not with the application position. The estimated mean PCF was 1.808, 3.529, and 3.925 L/s when supine and 1.672, 3.598, and 3.909 L/s when reclined from voluntary cough, MI-E, and MI-E with manual thrust, respectively. The estimated PCF change compared to voluntary cough was 1.721 (95% CI, 1.603–1.838) L/s from the combined MI-E and 2.116 (95% CI, 2.005–2.228) L/s from the MI-E with manual thrust, calculated from the linear mixed-model analysis. PCF moderately correlated with TIV (R | PMC10545699 |
Introduction | pneumonia, Tetraplegic, cord injury, atelectasis, abdominal muscle weakness, C-SCI, cough | RESPIRATORY FAILURE, PNEUMONIA, ATELECTASIS, NEUROMUSCULAR DISEASES | Respiratory and abdominal muscle weakness due to cervical spinal cord injury (C-SCI) results in a high mortality burden due to respiratory failure, including atelectasis, pneumonia, and ventilator failureAs one such airway clearance technique, mechanical insufflation–exsufflation (MI-E) is a noninvasive cough aid that augments in/exsufflation volume and flow by inducing a series of positive and negative pressures followed by a short pause. Gradual application of positive pressures to ensure sufficient inhaled volume to mobilize secretion and induce rapid shifts to negative pressures to produce a high expiratory flow can move secretions toward the mouth, allowing them to be easily removed. Tetraplegic individuals with a reduced peak cough flow (PCF) of less than 4.5–6 L/s (270 L/min)However, body position affects pulmonary function in people with C-SCI differently from that in healthy people or those with other neuromuscular diseases (NMD)MI-E-assisted cough can generate a sufficient insufflation volume more easily than voluntary or manually assisted cough. This is achieved through the application of external positive pressure to compensate for a deficient FVC. Once the maximal insufflation volume is achieved, the individual’s expiratory effort and strength would contribute less to the production of sufficient PCFThis pilot study aimed to investigate how body position influences PCF during MI-E treatment in individuals with C-SCI. Knowledge regarding the differences in PCF depending on body position could suggest proper positioning for MI-E use in individuals with C-SCI in clinical practice. | PMC10545699 |
Results | PMC10545699 |
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Factors associated with PCF | cough, PCF | The PCF during voluntary cough significantly differed between the positions with a mean PCF of 1.56 ± 0.51 L/s at supine and 1.36 ± 0.62 L/s at reclined positions, respectively (The linear mixed-model (LMM) analysis demonstrated no main effect of assigned group (There was a significant main effect of TIV (Linear mixed-effect model summarizing estimated mean differences of peak cough flow values by associated factors.CI, confidence interval; est. coeff, estimated coefficient; MI-E, mechanical insufflation–exsufflation; MT, manual thrust; TIV, total insufflation volume.*The final model specification was as follows:After adjusting for TIV and individual differences, the estimated mean PCF [95% confidence interval] was 1.808 [1.610–2.006] L/s in the supine position and 1.672 [1.471–1.873] L/s in the reclined position during voluntary coughing. For MI-E assisted coughs, the PCF increased to 3.529 [3.335–3.723] L/s in the supine position and 3.598 [3.405–3.792] L/s in the reclined position. When MI-E was combined with manual thrust, the PCF further improved to 3.925 [3.732–4.118] L/s in the supine position and 3.909 [3.716–4.103] L/s in the reclined position (Fig. Jitter plots described all measured peak cough flow values with estimated mean and standard error from linear mixed models during voluntary cough, MI-E-assisted cough, and MI-E-assisted with manual thrust, comparing supine and reclined positions, respectively. | PMC10545699 |
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Correlation between TIV and PCF | cough, cough flow(PCF | Because TIV was significantly associated with the generated PCF during MI-E, the correlation between TIV and PCF was analyzed in terms of the applied position. TIV during voluntary cough showed a difference according to the position (Pearson correlation analysis with confidence intervals between the total insufflation volume (TIV) and peak cough flow(PCF). | PMC10545699 |
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Discussion | cough, myopathy, PCF increase, C-SCI | MYOPATHY | Overall, this study revealed that there was no difference in PCF between the supine and reclined positions when MI-E was applied to patients with C-SCI. However, the generated PCF was affected by the application maneuver and MI-E with additional manual thrust resulted in the most substantial increase, approximately 2.116 [2.005–2.228] L/s, compared to voluntary cough. Although the body position itself did not directly alter PCF, the PCF increase from different maneuvers could be influenced by the position, resulting in a larger PCF increase in the reclined position. The provided TIV and individual differences in baseline pulmonary function made a difference of approximately 0.114–0.265 L/s.The estimated mean PCF [95% confidence interval] was 1.808 [1.610–2.006], 3.529 [3.335–3.723], 3.925 [3.732–4.118] L/s when supine and 1.672 [1.471–1.873], 3.598 [3.405–3.792], 3.909 [3.716–4.103] L/s when reclined from voluntary cough, MI-E, and MI-E with manual thrust, respectively, after adjusting the covariance of TIV and random effects of individual differences. The positional difference of the PCF only existed during voluntary coughing, and the final PCFs generated during MI-E assist or additional manual thrust were not different between the two applied positions. Although voluntary cough did not reach the 2.7 L/s threshold, which is considered essential for efficient sputum clearance from the lungsAlthough voluntary PCF was faster in the supine position compared to the reclined position, the increase in PCF from MIE-assist or additional manual thrust was more pronounced in the reclined position, ultimately resulting in a similar final PCF in both positions. It is also well correlated with the significant interaction factor between maneuver and position (Table A previous study investigating 36 patients with NMD suggested that the best individual PCF could be achieved with intermittent positive pressure breathing-assisted insufflationPrevious reports have shown an additional benefit of combining manual thrust with MI-E in patients with NMD, including myopathy or motor neuron disease, however, there is very little information regarding MI-E with manual thrust in tetraplegic individuals. Kim et al.Although PCF variations caused by the assistance of MI-E or manual thrust have been documented in different populations as mentioned aboveThis study had some limitations. First, we only measured PCF during cough but could not measure the exact amount of eliminated sputum to assess the effectiveness of the procedure in maintaining pulmonary hygiene. Additionally, comparing MI-E-assisted cough at 60° or 90° sitting position can provide more information about the best position for MI-E in people with C-SCI as well. Furthermore, information on long-term pulmonary prognosis, which is affected by the body position applied for MI-E treatment, will further empower future clinical decisions. Last, this pilot study is limited by a small, heterogeneous sample of individuals with varying SCI severities, restricting the generalizability of findings. The estimated sample size for paired t-tests is notably high due to the small mean differences relative to the standard deviations of differences. For instance, n = 557 would be needed for MI-E assisted cough, and n = 80,602 for assessing positional differences during MI-E combined with manual thrust. Therefore, it is imperative to utilize a small sample size but incorporate multiple, repetitive measures using LMM.In conclusion, the PCF during MI-E does not change according to the position, but a beneficial effect of applying MI-E and additional manual thrust could be achieved in both the supine and reclined positions. Generated TIV during cough was important in determining PCF in both positions. Hence, either position can be used as long as MI-E can be performed together with manual thrust and sufficient TIV is provided. | PMC10545699 |
Methods | PMC10545699 |
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Study Participants | cough, impaired cough, C-SCI | This prospective, randomized crossover pilot study recruited C-SCI patients with impaired cough who required further cough augmentation, defined by a PCF < 270 L/min | PMC10545699 |
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Study design | cough, coughs, fatigue | Eligible participants were randomized in a 1:1 ratio into groups I or II without stratification using a computer-generated block size of 4. Group I started in the supine position, was later reclined to 40° on the first day, and then the reclined position first followed by the supine position on the next day. Conversely, Group II underwent four sessions of MI-E in the opposite order of the applying position. The angle of 40°-reclining was chosen because previous studies have shown that this angle can achieve a more effective manual thrust combined with MI-E than in a 90°-sitting positionThe study design provides alternating starting positions of either supine or reclined for each day and each group because the cumulative treatment effect can also affect the generated PCF during MI-E. Consecutive MI-E application with eliminated sputum between coughs affects airway resistance and generates better PCF. However, repetitive cough combined with MI-E assistance would result in fatigue because of repeated maximal effort during exsufflation and decreased PCF. Conversely, if more MI-E treatment sessions are completed, more experienced participants can cooperate better with MI-E, which generates a faster PCF. This bias from repetitions of the MI-E application could be avoided by changing the order of the applied posture for every session for all participants. | PMC10545699 |
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MI-E application | cough | MI-E treatment sessions were administered using the CoughAssist E70 (Phillips Respironics, Murrysville, Pennsylvania), which was set to generate 3 s of insufflation, 2 s of exsufflation, and 2 s of rest for one cough, with a low inhale flow setting and oscillation off to simulate physiological coughing and facilitate better cooperation for higher in-exsufflation pressureAfter determining the optimal MI-E pressure settings, the protocol comprised five consecutive voluntary coughs following 3 s of full inspiration, 2 s of maximal expiration, and rest was initiated. Participants were instructed to cough five times into the facemask while wearing a well-sealed mask (Air Way 96 mm (#4), ACE Medical Co., South Korea) with support from a physiotherapist or caregiver to prevent any air leak. After eliminating the expelled sputum, one set of five MI-E-assisted coughs was provided, followed by another set of five more MI-E-assisted coughs with manual thrusts. The three sets (5 coughs/1 set) of different application maneuvers—voluntary cough, MI-E assist, and MI-E with manual thrust—comprised one session at each position, and these three sets were repeated in the same order at the next assigned position.When performing MI-E combined with manual thrust, the physiotherapist asked the participant to cough at the start of the exsufflation period while delivering manual pressure to the participant’s bilateral costophrenic angle toward the direction of the upper chest simultaneously. An experienced physiotherapist blinded to the analysis of the mean PCF conducted all MI-E treatments and measured the concomitant airflow. A separate researcher blinded to the assigned group and applied position performed all the analyses. | PMC10545699 |
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Expiratory flow measurement | cough, Expiratory airflow | The in-expiratory airflow generated in both directions during the MI-E session was measured using a flowmeter (CITREX H4 gas flow analyzer, IMT Analytics, Buchs, Switzerland) serially connected to one side of a single-use antibacterial filter towards the facemask interface, and the other side to the CoughAssist E70. This flowmeter was formally calibrated and validated annually by IMT Analytics to ensure that the maximal uncertainty error was within 0.75% for all measurements. Expiratory airflow was measured as a negative value; therefore, the lowest value during exsufflation was the PCF, which could be calculated from each cough with continuous airflow measurement | PMC10545699 |
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Statistical analysis | The LMM was used to estimate mean PCF, standard error, and confidence interval which described the changes in the PCF according to the position or maneuver. Applied position, maneuvers, TIV, and interaction between maneuver and position were included as fixed effects, and participant-specific random intercepts were included as a random effect to account for repeated measures within participants covering individual, different baseline pulmonary functions. The normality test was confirmed for residuals. The strength of the linear correlation between PCF and TIV was analyzed using Pearson’s correlation analysis after calculating the correlation coefficient R | PMC10545699 |
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Acknowledgements | The authors appreciate a skillful therapist who conducted all pulmonary rehabilitation using MI-E in this study and the Medical Research Collaborating Center for statistical advice. | PMC10545699 |
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Author contributions | S.E.H.: Project conception and organization, Project execution, Interpretation of data, Manuscript writing; H.I.S.: Project conception and organization, Interpretation of data, Manuscript writing, review, and critique; W.J.H. & H.M.J.: Project execution, interpretation of data, manuscript review. | PMC10545699 |
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Funding | This study was supported by the Rehabilitation Research & Development Support Program (#NRCRSP-EX20007) of the National Rehabilitation Center, Ministry of Health and Welfare, Korea. | PMC10545699 |
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Data availability | The data generated and/or analyzed during the current study are available from the corresponding author upon reasonable request. | PMC10545699 |
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Competing interests | The authors declare no competing interests. | PMC10545699 |
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References | PMC10545699 |
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Background | People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, but there are limited data about their effectiveness. | PMC10131829 |
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Objective | We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit. | PMC10131829 |
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Methods | SECONDARY | We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the study was the carbon monoxide–confirmed continuous abstinence rate from week 4 to week 12 (CAR weeks 4-12). The secondary endpoints included the continuous self-reported ≥50% reduction in cigarette consumption rate (continuous reduction rate) from week 4 to week 12 (CRR weeks 4-12) and 7-day point prevalence of smoking abstinence. | PMC10131829 |
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Results | A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant ( | PMC10131829 |
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Conclusions | Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alternatives for tobacco cigarettes and may contribute to smoking cessation. However, longer follow-up studies are required to confirm significant and prolonged abstinence from smoking and to determine whether our results can be generalized outside smoking cessation services offering high levels of support. | PMC10131829 |
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Trial Registration | ClinicalTrials.gov NCT03569748; https://clinicaltrials.gov/ct2/show/NCT03569748 | PMC10131829 |
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Introduction | premature deaths | HEAT | According to the World Health Organization, smoking is endemic, with more than 1.1 billion smokers worldwide, resulting in approximately 7 million premature deaths every year [Achieving cessation is challenging, because quit rates are low, relapse rates are high, and many smokers wish to continue to smoke [Substitution of combustible tobacco cigarettes with less harmful combustion-free nicotine delivery alternatives (NDAs), such as electronic cigarettes (ECs) and heated tobacco products (HTPs), is now a relatively new option available to smokers [ECs operate by heating an element that vaporizes a solution. HTPs consist of a holder that electronically transfers controlled heat to tobacco sticks that generate a nicotine-containing aerosol. Since the emission aerosols of combustion-free NDAs are produced at a much lower vaporizing/heating temperature compared to that of combustion (which generally starts above 400 °C), they contain less harmful and potentially harmful chemicals than tobacco smoke [Although not completely risk free, EC and HTP use may help respiratory patients to achieve sustained abstinence from cigarette smoking, with clinically relevant health gains [HTPs often mimic a hand-to-mouth experience that is very similar to that of conventional tobacco cigarettes. By mimicking the experience of tobacco smoking and its associated rituals, the use of HTPs can provide adequate compensatory physical and behavioral effects [It is not clear if HTPs provide a more gratifying smoking experience compared to ECs, and a direct comparison between the 2 types of products has never been investigated. With this in mind, we conducted a prospective randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction/adoption between HTPs and refillable ECs among people who smoke and do not intend to quit. | PMC10131829 |
Methods | PMC10131829 |
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Study Participants | Eligibility criteria have been described previously in detail [ | PMC10131829 |
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Trial Design and Study Visits | Details of the study design and protocol have been previously published [The study was conducted in accordance with the Guideline for Good Clinical Practice and followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines for randomized studies (CONSORT (Consolidated Standards of Reporting Trials) flow diagram. EC: electronic cigarette; HTP: heated tobacco product. | PMC10131829 |
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Study Products | HTPs and ECs were provided for the whole duration of the intervention phase (12 weeks). | PMC10131829 |
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HTPs | Participants randomized to the HTP arm of the study received IQOS 2.4 Plus consisting of a pen-like holder into which a tobacco stick is inserted and heated, and a battery case to recharge the holder after each use. IQOS 2.4 Plus was the only HTP available on the Italian market when this trial was designed. The device is to be used with tobacco sticks specifically processed and manufactured for IQOS (named | PMC10131829 |
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ECs | Participants randomized to the EC arm of the study received JustFog Q16 Starter Kit consisting of a battery and a 1.9-mL refillable tank fitted with a 1.6-Ohm nichrome coil. Participants could choose from 3 varieties of e-liquid flavors (Puff Riserva Country 16 mg, sweet tobacco flavor; Puff Riserva Toscana 16 mg, full tobacco flavor; and Puff Artic 16 mg, menthol flavor; all 3 are formulated in 50% propylene glycol/40% vegetable glycerin/10% H | PMC10131829 |
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Study Endpoints | SECONDARY | The primary efficacy endpoint of the study was the continuous abstinence rate (CAR) from week 4 to week 12 (CAR weeks 4-12). Abstinence from smoking was defined as eCO-verified (<10 ppm) self-reported abstinence from cigarette smoking. CAR weeks 4-12 was used to compare quit rates between IQOS-HTP and JustFog-EC.The secondary efficacy endpoints were the 7-day point prevalence of abstinence at week 12 and the continuous reduction rate (CRR) from week 4 to week 12 (CRR weeks 4-12). Smoking reduction was self-reported. A reduction in the number of cigarettes smoked per day of 50% from baseline was considered of importance and excluded those labeled as CAR weeks 4-12. The CRR weeks 4-12 was used to compare reduction rates between IQOS-HTP and JustFog-EC. Participants who could not be classified as CAR weeks 4-12 or CRR weeks 4-12 were considered to have failed. Safety reporting details have been previously published [Product satisfaction was investigated by using the following questionnaires adapted and validated for EC and HTP use: modified Cigarette Evaluation Questionnaire (mCEQ) and modified Smoking Cue Appeal Survey (mSCAS). Risk perception was assessed by using the Perceived Risk Instrument for conventional cigarettes (PRI-P CC) and the Perceived Risk Instrument for reduced risk products (PRI-P RRP). The effect on quality of life was investigated by questionnaires (ie, EQ-5D-5L and EQ VAS) and by measuring changes in body weight and exercise tolerance (ie, V̇O | PMC10131829 |
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Study Assessments | The assessments carried out during study visits are listed in Other measurements included the following questionnaires: (1) Fagerstrom Test for Cigarette Dependence [Secondary analyses of blood pressure, heart rate, BMI, and Chester step test results by smoking phenotype classification will be reported in separate papers. | PMC10131829 |
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Ethical Considerations | The Ethical Review Board of Azienda Ospedaliero Universitaria “Policlinico-V. Emanuele,” Università di Catania, Italy, reviewed and approved the study (approval reference number: 215/2017/PO). All participants provided written informed consent prior to participation in the study. The study has been registered at ClinicalTrial.gov (trial registration ID: NCT03569748). Study data are deidentified, and participants did not receive compensation. | PMC10131829 |
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Statistical Methods | REGRESSION, EVENTS | A detailed description of the sample size calculation can be found in the published research protocol [All the analyses were performed using SAS Version 9.4 (SAS Institute Inc). The primary efficacy endpoint of the study in the experimental study group was calculated with a noninferiority threshold of 15%. An α level of .05 was considered. Quit rates were evaluated on an intention-to-treat basis. CAR weeks 4-12 percentages and odds ratios (ORs) were calculated and used to compare quit rates between the IQOS-HTP and JustFog-EC study groups with the chi-square test. Moreover, CRR weeks 4-12 percentages and ORs were calculated and used to compare reduction rates between the IQOS-HTP and JustFog-EC study groups with the chi-square test. For the 7-day point prevalence of smoking abstinence and reduction, percentages were calculated at each study visit to illustrate trends.Safety data were presented as descriptive statistics separately by study group. Any events documented in the period from the point of product randomization (V1) until the end of the intervention phase at 12 weeks when study products were withdrawn (V6) were considered as relevant for safety analysis.Descriptive statistics of product acceptability measures (ie, mCEQ and mSCAS) were presented as summary tables by study group and study visit. Changes in mCEQ and mSCAS scores within and between study groups were analyzed using the Wilcoxon signed rank test and Wilcoxon rank sum test, respectively.For risk perception, descriptive statistics of PRI-P CC and PRI-P RRP values were presented as summary tables by study group and study visit. Changes in PRI-P scores within and between study groups were analyzed using the Wilcoxon signed rank test and Wilcoxon rank sum test, respectively.EQ-5D-5L, EQ VAS, body weight, and exercise tolerance were presented as descriptive statistics, and within- and between-group comparisons were carried out using the Wilcoxon signed rank test and Wilcoxon rank sum test, respectively.A multiple logistic regression model was prepared to identify variables able to influence the primary outcome CAR weeks 4-12. We performed an a priori selection of variables able to act as determinants, effect modifiers, or confounders of quitting success. The continuous variables were categorized according to cutoffs based clinically. The univariate analysis was performed considering the subgroups CAR and no CAR as the outcome. The following factors, for which a statistical difference was detected, were included in the model: gender, daily cigarette consumption, and 4 psychological aspects included as domains in the questionnaires (ie, product satisfaction, psychological reward, enjoyment, and craving). | PMC10131829 |
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Results | PMC10131829 |
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Smoking Abstinence and Reduction Rates | smoking reduction | Smoking abstinence rates (CAR weeks 4-12), reduction rates (CRR weeks 4-12), and 7-day point prevalence of smoking abstinence and reduction are shown in Smoking abstinence rates and smoking reduction rates. CAR: continuous abstinence rate; CRR: continuous reduction rate; EC: electronic cigarette; HTP: heated tobacco product.Seven-day prevalence of smoking abstinence and reduction in the electronic cigarette (A) and heated tobacco product (B) study groups.High quit rates, evaluated on an intention-to-treat basis, were observed for both study groups; the CAR weeks 4-12 values for IQOS-HTP and JustFog-EC were 39.1% (43/110) and 30.8% (33/107), respectively (High reduction rates, assessed among participants who were still smoking, were also reported, and the CRR weeks 4-12 values for IQOS-HTP and JustFog-EC were 46.4% (51/110) and 39.3% (42/107), respectively (The 7-day point prevalence of smoking abstinence was >20% throughout the intervention phase, with values peaking at week 8 (V5) and week 12 (V6) (The 7-day point prevalence of smoking reduction (ie, dual use) was higher during the first 2 weeks of the intervention phase (For both study products, | PMC10131829 |
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Product Preference, Acceptability, and Risk Perception | Among participants in the EC study arm, 50.9% (56/110) chose Puff Riserva Country, 30.9% (34/110) chose Puff Riserva Tuscan, and 18.2% (20/110) chose Puff Artic e-liquid. Among participants in the HTP study arm, 56.4% (62/110) chose Appeal of the study products was analyzed using the mCEQ and mSCAS. No significant within-group changes in the mCEQ and mSCAS scores were observed (Wilcoxon signed rank test; As expected, risk perception for conventional cigarettes was consistently higher than for the combustion-free study products (Consumption patterns of conventional tobacco cigarettes, vaping products, and HTPs throughout the study are illustrated in | PMC10131829 |
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Evaluation of Participant Well-being | EQ-5D-5L and EQ VAS results are summarized in Changes in exercise tolerance between study products were not significant (Chester step test results. EC: electronic cigarette; HTP: heated tobacco product; NS: not significant. | PMC10131829 |
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Predictors of Smoking Abstinence | craving reduction | REGRESSION | The results of the abovementioned logistic regression model showed the following evidence: males were less likely to achieve CAR weeks 4-12 compared to females (OR 0.457, 95% CI 0.249-0.840), subjects who had a high consumption of the product were likely to achieve CAR weeks 4-12 compared to those who had a low consumption of the product (OR 0.450, 95% CI 0.212-0.956), and subjects who had a high craving reduction were likely to achieve CAR weeks 4-12 compared to those who had a low craving reduction (OR 0.391, 95% CI 0.186-0.825). | PMC10131829 |
Adverse Events | ADVERSE EVENTS | The reported numbers of adverse events are listed in | PMC10131829 |
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Discussion | cough, RE, COPD, Cancer | INFECTIOUS DISEASES, ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, RECRUITMENT, COPD, DEL, CANCER | HTP use elicited a marked reduction in cigarette consumption, resulting in almost 40% abstinence from smoking by the end of the study. When present, adverse events were mild and transitory. This is the first study to directly compare ECs to HTPs, showing comparable effectiveness and tolerability between the JustFog-EC and IQOS-HTP study groups.RCT findings for IQOS-HTP are in agreement with the findings of an American Cancer Society analysis that found a substantial decline in cigarette sales after the introduction of IQOS in Japan [Multiple factors contributed to the high quit rate observed among IQOS-HTP and JustFog-EC users: (1) participants were keen to switch to combustion-free NDAs; (2) personalized motivational counseling was administered by psychologists proficient in both smoking cessation and harm reduction at each study visit; (3) top selling products in their respective category (ie, JustFog for ECs and IQOS for HTPs) were given for free in the study and most participants found these products appealing; (4) study products had a pharmacokinetic profile of nicotine uptake mimicking that of conventional cigarettes [The same factors might have contributed to the comparable effectiveness between ECs and HTPs and to the progressive transition from dual use to solo use by the end of the intervention phase. Dual use is known for being a common transitory state, with transitions to solo use taking variable time to occur [For this study, we selected the top selling products in their respective category (ie, ECs and HTPs). Both IQOS-HTP and JustFog-EC performed well in the study, as technical issues (eg, malfunctions) were relatively uncommon. Participants enjoyed using both study products, with mCEQ scores showing mild to moderate positive responses in terms of product acceptability, cigarette craving reduction, and physical and psychological reward; mSCAS scores indicating a moderately pleasant user experience; and consumption data revealing regular constant product use throughout the study. This is consistent with the notion that a positive sensorial experience and product enjoyment can contribute to the effectiveness of combustion-free products in terms of cessation outcomes [Adverse events were mild and did not led to discontinuation of product use in either study group. None of the participants abused the products under investigation in terms of excessive daily consumption. In some participants, HTP use was associated with mild cough and reduced physical fitness in line with previous observations [A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation as early as 4 weeks. Greater improvement was observed at 12 weeks as there was a much higher prevalence of quitters by the end of the intervention phase compared to 4 weeks. This is in agreement with the improvement in the level of exercise tolerance shown in prospective studies of COPD patients who switched to ECs [The trial had strengths and limitations. First, among the innovative features of this randomized controlled switching study, adherence to the study products was enhanced by offering a selection of different products to choose from according to preference/liking. Three aromas of tobacco sticks and three e-liquid flavors were provided to best match participants’ sensorial experiences. Nonetheless, these choices remain limited (ie, only 3 different flavors for each class of products) and product specific, thus reducing the generalizability of the study findings. In addition, multiple flavor use is common among e-cigarette users, and switching between flavors is frequently reported even during daily use [Second, after close scrutiny, we chose to offer the best vaping devices and HTPs available on the Italian market at the time of the study. More details about the selection process have been published previously [Third, study products were provided in combination with personalized motivational counseling administered by psychologists proficient in both smoking cessation and harm reduction. Provision of expert guidance in the context of a switching trial conducted at specialized smoking cessation services may limit the generalizability of the study findings. Changes in tobacco/nicotine use behavior and product use will be investigated in a separate follow-up study under real-life conditions.In conclusion, this study confirmed the effectiveness of ECs for cigarette substitution and smoking cessation [The authors would like to thank the staff at Centro Prevenzione Cura Tabagismo (CPCT) for their invaluable assistance with subject recruitment. We are also grateful to Fabio Cibella for the fruitful scientific advice about the statistical analysis plan and Adrian Shalivari for the refinement of the electronic data capture system. The authors’ thoughts and prayers go out to all the victims of the Russia-Ukraine conflict. This research was supported by an investigator-initiated study award by Philip Morris Products SA (PMI.IIS.2016.006). Philip Morris Products SA had no role in the design of the study and will not have any role during its execution, data analysis, or data interpretation, or during writing of the manuscript.Conflicts of Interest: PC, DC, MS, M Migliore, and M Caruso are full-time employees of the University of Catania, Italy. RE is a fixed-term researcher at BIOMETEC, University of Catania, Italy. M Maglia and FB are fixed-term researchers at Centro per la Prevenzione e Cura del Tabagismo, University of Catania, Italy. BB is a full-time employee of ARNAS Garibaldi, Catania, Italy. AP is a full-time employee of Casa di Cura Musumeci-Gecas, Gravina di Catania, Italy. GC is a full-time employee of the Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Messina, Italy. M Ceracchi is an employee at FullCRO, Roma, Italy.Study diagram.Study schedule and assessments.Detailed technical issues.Summary of the measures of product preference, acceptability, and risk perception.Risk perception.Consumption data for study participants (per protocol population).Average daily consumption.Summary of the measures of participant well-being.Adverse Events.CONSORT 2010 checklist. | PMC10131829 |
Abbreviations | continuous abstinence rateConsolidated Standards of Reporting Trialschronic obstructive pulmonary diseasecontinuous reduction rateelectronic cigaretteexhaled carbon monoxideheated tobacco productmodified Cigarette Evaluation Questionnairemodified Smoking Cue Appeal Surveynicotine delivery alternativeodds ratioPerceived Risk Instrument for conventional cigarettesPerceived Risk Instrument for reduced risk products | PMC10131829 |
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Data Availability | We may share deidentified individual participant-level data that underlie the results reported in this article. Data will be available on receipt of a request detailing the study hypothesis and statistical analysis plan. All requests should be sent to the corresponding author. Based on the scientific rigor of the proposal, the study authors will discuss all requests and decide whether data sharing is appropriate. All applicants will be asked to sign a data access agreement. | PMC10131829 |
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Background | cognitive decline | Finding innovative yet feasible ways of preventing physical and cognitive decline in those at risk is a critical global challenge, with exercise being championed as a key precursor to robust health in later life. Exercise snacking, here defined as short bouts of sporadic [muscle-strengthening] exercise, is one such strategy designed to overcome typical participation barriers observed in older adults. This study examined the acceptability of exercise snacking amongst pre-frail older adults and explored the efficacy of this approach in improving physical function. | PMC10403822 |
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Methods | mild-cognitive impairment | In this single group design, 21 pre-frail outpatients with mild-cognitive impairment were recruited from a UK memory clinic. To be eligible, participants were aged ≥ 65-years who scored 3–8 (inclusive) on the short physical performance battery (SPPB) and were not regularly engaging in sport or exercise. Participants completed a 28-day, twice daily, exercise snacking intervention, consisting of five muscle-strengthening exercises, with the aim being to complete as many repetitions as possible of each exercise in a minute. Acceptability of the intervention was measured quantitatively and qualitatively using a survey and topic guide informed by the Theoretical Framework of Acceptability. Pre- and post-intervention physical function was measured using the SPPB, timed up-and-go (TUG), and 60s standing balance and sit-to-stand tests. | PMC10403822 |
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Results | Eighteen participants provided follow-up data and showed 85% adherence to the exercise snacking intervention, measured as the proportion of all sessions completed out of a possible 56. Participants rated the intervention as highly acceptable (4.6/5) suggesting it supported their self-efficacy (4.3/5) was enjoyable (4.1/5) and had a low burden (2.1/5). Qualitative findings suggested the ease of use, flexibility of the programme, and perceived effectiveness was important, and particularly useful for non-exercisers. Changes in SPPB score (8(1) vs. 9(3), p < 0.01), TUG (11.32(4.02) vs. 9.18(5.25) seconds, p < 0.01) and in the 60-second sit-to-stand test (17 ± 5 vs. 23 ± 7 repetitions, p < 0.01) were seen between baseline and follow-up. | PMC10403822 |
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Conclusions | Exercise snacking is an acceptable and potentially efficacious format of exercise for pre-frail memory clinic attendees who are at heightened risk of falling and frailty. Large scale randomised controlled trials are required to confirm whether exercise snacking is effective in the short and long term. | PMC10403822 |
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ClinicalTrials.gov registration | NCT05439252 (30/06/2022) | PMC10403822 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12877-023-04169-6. | PMC10403822 |
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Keywords | PMC10403822 |
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Background | cognitive decline, dementia, cognitive impairment | The prevalence of age associated physical and cognitive decline is markedly rising due to the ageing population and places an enormous strain on health and social care in the UK [Older people with cognitive impairment are markedly more likely to have reduced physical function and strength, and ultimately a greater fall risk [There is promising evidence that exercise programmes may improve the ability of people with dementia to perform activities of daily living [Exercise snacking is a mode of exercise that aims to have maximum impact on physical function at minimum ‘cost’ to the patient in terms of time, money and no requirement for specialist exercise facilities or equipment [Key to the success of any [new] intervention is that it is centred around the specific needs of the target population [
to examine the acceptability of the exercise snacking intervention guided by the Theoretical Framework of Acceptability (TFA) and identify areas that may need to be improved to optimise it for attendees of a memory clinic.to explore and characterise the potential impact of this intervention on the physical function for this population on outcomes relating to physical function, health, and exercise cognitions. | PMC10403822 |
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Methods | PMC10403822 |
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Study design | ’ | This pilot study used a single group, pre-test-post-test design to assess the acceptability homebased ‘exercise snacking’ in older adult patients attending the memory clinic at the Research Institute for the Care of Older People (RICE) in Bath, UK. All participants were asked to undertake 28 days of twice daily exercise snacks, with baseline measures of physical and cognitive function, patient reported health, wellbeing, and psychological process outcomes relating to exercise behaviour, recorded on the day before the intervention and follow-up measures scheduled within 7-days of the final day of the intervention. The primary outcome of intervention acceptability was measured by self-report questionnaire, with participants also invited to participate in a qualitative interview of their experience of the intervention. | PMC10403822 |
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Participants | cognitive impairment | RECRUITMENT | Outpatients attending the memory clinic at RICE who were identified as being potentially eligible to participate in the present pilot study were invited to participate by RICE gerontology clinicians. Interested individuals were referred to study staff, with clinicians taking no further roll in study procedures. Eligibility requirements were age > 65 years; diagnosed mild cognitive impairment only (Mini-Mental State Examination (MMSE) [With intervention acceptability as a primary outcome measure, there is a lack of comparable literature to quantitatively estimate a required sample size in this population, given adherence rates to the exercise snacking intervention are yet to be established. As such, for reasons of pragmatism and a fixed duration of study funding, a target of 20 participants to complete follow-up measurements in a three-month testing window was set. Participants who had not adhered to the intervention were included within this target sample size, so long as they would attend follow-up assessment. This approach was taken in an attempt to avoid a withdrawal bias, i.e., only participants who adhered to the intervention returning for follow-up assessment thus positively skewing interpretation of intervention acceptability. A rolling recruitment strategy was employed whereby up to 10 extra participants could be recruited to replace participants who withdrew from the study and were not willing or able to attend follow-up assessments, provided there was sufficient time to enrol and complete follow-up assessments of the replacement participants in the three-month testing period. | PMC10403822 |
Assessments | RPE | Intervention acceptability was assessed by a theoretical framework of acceptability questionnaire on participant experiences of exercise snacking completed at the follow-up assessment only. The seven domains (Affective attitude; Burden; Ethicality; Intervention Coherence; Opportunity Cost; Perceived effectiveness; and Self-efficacy) of the TFA along with overall acceptability were measured using an 8-item questionnaire [During eligibility screening, baseline characteristics were collected (Table At baseline and follow-up assessments, participants completed questionnaires on their attitude towards the benefits of exercise using the Multidimensional Outcome Expectancy for Exercise Questionnaire [Alongside the SPPB, physical function was also assessed by a 60-second sit-to-stand test, in which participants were instructed to complete as many repetitions as possible in 60 s from a hard backed chair with seat height of 45 cm. Participants were permitted to use their arms for balance, but not to use their arms to propel or push themselves out of the chair. To avoid any self-pacing, participants were positioned out of view of a clock and the researcher did not count the repetitions out loud. A single attempt was permitted, and rating of perceived exertion (RPE [To characterise habitual physical activity and assess intervention adherence, a wearable physical activity monitor (ActivPAL4, PAL Technologies ltd, Glasgow, UK) was worn on the thigh for the seven consecutive days after the baseline assessment. The device was mounted under an adhesive waterproof dressing so it could be worn continuously, including during water-based activity. Participants were provided with a pre-paid and addressed envelope in which to return the device following seven days of wear. | PMC10403822 |
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Intervention | ADVERSE EVENTS, MINOR, EVENT | The exercise snacking intervention consisted of five exercises, each performed for one minute interspersed with one minute of seated rest, with the aim being to complete as many repetitions as possible of each exercise in the given minute. The total length of each exercise ‘snack’ was therefore nine minutes. Participants were instructed to complete the exercises twice a day at home, and only to perform exercise snacks when there was someone else present in the home with capacity to call for help in the event of an emergency. The exercises were sit-to-stand from a chair, seated lateral arm raising to overhead, marching on the spot with high knees (aiming for thigh parallel to the floor), seated arm crossing from arms down by the sides to touching opposite shoulders, and seated calf raises. Participants were provided with a set of written and pictorial instructions on how to complete the exercises along with a logbook in which to record the number of sit-to-stand repetitions completed in each exercise snack, along with a rating of perceived exertion (1–10 scale) for the whole exercise snack. The logbook included space to record minor adverse events or notes from the participant, and clear instruction for reporting serious adverse events to study staff. This logbook was to be returned following the intervention to assess intervention adherence. See Additional file | PMC10403822 |
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Statistical analysis | The primary outcome of acceptability of the exercise snacking intervention was assessed descriptively based on the scores from the TFA questionnaire, and qualitatively using framework analysis [ | PMC10403822 |
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