title: Hospital vs Home-Based Exercise Rehabilitation for Patients with Peripheral Arterial Occlusive Disease Evaluation of patient compliance, quality of life impact and cost-effectiveness of a "test in-train out" exercise-based rehabilitation program for patients with intermittent claudication. Efficacy of Quantified Home-Based Exercise and Supervised Exercise in Patients With Intermittent Claudication: A Randomized Controlled Trial Effects of a Home-Based Walking Intervention on Mobility and Quality of Life in People With Diabetes and Peripheral Arterial Disease The vascular nurse in practice: Results of prescribed exercise training in patients with intermittent claudication. The Group Oriented Arterial Leg Study (GOALS) to improve walking performance in patients with peripheral arterial disease. A primary care walking exercise program for patients with intermittent claudication. Physiological and functional impact of an unsupervised but supported exercise programme for claudicants. Value of a supervised exercise program for the therapy of arterial claudication. Physical training for intermittent claudication: a comparison of structured rehabilitation versus home-based training Effects of home versus supervised exercise for patients with intermittent claudication. GRADE guidelines: 3. Rating the quality of evidence. Limb-specific and cross-transfer effects of arm-crank exercise training in patients with symptomatic peripheral arterial disease. Training rather than walking: the test in -train out program for home-based rehabilitation in peripheral arteriopathy.
abstract: Supervised , hospital-based exercise rehabilitation programs are effective for improving functional status for patients with claudication due to peripheral arterial occlusive disease . However , it has been suggested that unsupervised , home-based exercise programs , which have been relatively little evaluated , would be equally efficacious as compared with hospital-based programs . The authors tested the hypothesis that a hospital-based exercise rehabilitation program would improve treadmill exercise perfor mance more than a home-based program . Of 20 consecutively enrolled patients with claudication , 10 were r and omly placed into a supervised , hospital-based program and 10 into an unsupervised , home-based program for a three-month period .  Exercise perfor mance was evaluated by treadmill testing using a grade d protocol . In addition , func tional status was evaluated by the Walking Impairment Question naire ( WIQ ) and the Medical Outcomes Study SF-20 question naire ( MOS ) . Patients in the hospital-based program were treated with treadmill walking three times a week for one hour/visit . Patients in the home-based program were instructed to walk at least three times a week and were contacted weekly to provide encouragement and to record compliance with ( continued on next page ) the program . Patients in the hospital-based group improved peak walking time by 137 % , pain-free walking time by 150 % , and peak oxygen consumption by 19 % ( all P<0.05 ) . Patients reported an improved walking distance and speed according to WIQ data ( both P<0.05 ) . In addition , the MOS physical functioning score in the hospital-based group improved by 20 percentage points ( P<0.05 ) . In contrast , patients in the home-based program did not improve exercise performance measured on the treadmill . Improvement in the ability to walk on the treadmill was greater in the hospital-based than the home- based program ( P<0.05 ) . The ability to walk distances was the only question naire measure that improved in persons who received the home-based program ( P<0.05 ) . Preliminary results suggest that a supervised , hospital-based program is more effective for improving treadmill exercise performance than an unsupervised , home-based program BACKGROUND Patients with intermittent claudication ( IC ) could benefit from low-cost , effective rehabilitative programs . This retrospective study evaluates compliance , impact on Quality of Life ( QoL ) and cost-effectiveness of a hospital prescribed , at-home performed ( Test-in/Train-out ) rehabilitative program for patients with IC . METHODS AND RESULTS Two-hundred and eighty-nine patients with IC ( 71 ± 10.1 years , M = 210 ) were enrolled for a 2-year period .  Two daily 10-min home walking sessions at maximal asymptomatic speed were prescribed , with serial check-ups at the hospital . Compliance with the program was assessed by assigning a score of 1 ( lowest compliance ) to 4 ( highest compliance ) . The SF-36 question naire and a constant-load treadmill test  were used to evaluate QoL and Initial/Absolute Claudication Distance , respectively . Both direct and indirect costs of the program were considered for cost-effectiveness analysis . Two-hundred and fifty patients ( 70.5 ± 9.2 years , M = 191 ) , at Fontaine 's II-B stage ( 86 % ) , were included in the study . No adverse events were reported . The average compliance score was 3.1 . At discharge , both SF-36 domains and walking performance significantly increased ( P < 0.0001 ) . A total of 1,839 in-hospital check-ups ( 7.36 /patient ) were performed . Direct and indirect costs represented 93 % and 7 % of the total costs , respectively . The average costs of a visit and of a therapy cycle were C68.93 and C507.20 , respectively . The cost to walk an additional meter before stopping was C9.22 . CONCLUSIONS A Test-in/Train-out program provided favourable patient compliance , QoL impact and cost-effectiveness in patients with IC Background — This prospect i ve , r and omized , controlled clinical trial compared changes in exercise performance and daily ambulatory activity in peripheral artery disease patients with intermittent claudication after a home-based exercise program , a supervised exercise program , and usual-care control . Methods and Results — Of the 119 patients r and omized , 29 completed home-based exercise  , 33 completed  supervised exercise , and 30 completed usual-care control . Both exercise programs consisted of intermittent walking to nearly maximal claudication pain for 12 weeks . Patients wore a step activity monitor during each exercise session . Primary outcome measures included claudication onset time and peak walking time obtained from a treadmill exercise test ; secondary outcome measures included daily ambulatory cadences measured during a 7-day monitoring period . Adherence to home-based and supervised exercise was similar ( P=0.712 ) and exceeded 80 % . Both exercise programs increased claudication onset time ( P<0.001 ) and peak walking time ( P<0.01 ) , whereas only home-based exercise increased daily average cadence ( P<0.01 ) . No changes were seen in the control group ( P>0.05 ) . The changes in claudication onset time and peak walking time were similar between the 2 exercise groups ( P>0.05 ) , whereas the change in daily average cadence was greater with home-based exercise ( P<0.05 ) . Conclusions — A home-based exercise program , quantified with a step activity monitor , has high adherence and is efficacious in improving claudication measures similar to a st and ard supervised exercise program . Furthermore , home-based exercise appears more efficacious in increasing daily ambulatory activity in the community setting than supervised exercise . Clinical Trial Registration — URL : http://www . Clinical Trials . Gov . Unique identifier : NCT00618670 OBJECTIVE Determine the efficacy of a home-based walking intervention to improve walking ability and quality of life in people with diabetes and peripheral arterial disease ( PAD ) . RESEARCH DESIGN AND METHODS We conducted a r and omized , controlled , single-blind trial within university-affiliated clinics in our local community . We r and omized 145 participants ( 45 women ) with diabetes and PAD to our intervention — a 6-month behavioral intervention targeting levels of readiness to engage in routine walking for exercise — versus attention control . Our primary outcome was 6-month change in maximal treadmill walking distance . Secondary outcomes included 3-month change in maximal walking distance , lower limb function ( i.e. , walking impairment scores ) , quality of life ( Medical Outcomes Short Form Survey ) , exercise behaviors , depressive symptoms , and self-efficacy at 3 and 6 months . RESULTS The mean age of participants was 66.5 ( SD 10.1 ) years . Intervention and control groups did not differ significantly in 6-month change in maximal treadmill walking distance ( average [ SE ] 24.5 [ 19.6 ] meters vs. 39.2 [ 19.6 ] meters ; P = 0.60 ) . Among secondary outcomes , for the intervention and control groups , respectively , average walking speed scores increased by 5.7 [ 2.2 ] units and decreased by 1.9 [ 2.8 ] units ( P = 0.03 ) ; the mental health quality of life subscale score increased by 3.2 [ 1.5 ] and decreased by 2.4 [ 1.5 ] units ( P = 0.01 ) . CONCLUSIONS A home-based walking intervention did not improve walking distance but did improve walking speed and quality of life in people with diabetes and PAD . Clinicians should consider recommending home-based walking therapy for such patients Intermittent claudication ( IC ) is a mild stage of peripheral arterial disease that affects between 3 % and 7 % of the population and up to 1 in 5 patients over the age of 75 years . Risk factors such as hypertension , hyperlipidemia , diabetes , smoking , and genetics increase the incidence of peripheral arterial disease . Patients with IC have limitations in functional capacity and can benefit from regular exercise . Walking is the preferred mode of exercise and improves the symptoms of claudication in several ways . Vascular nurses can play an important role during exercise therapy . A personalized , home-based exercise program can be developed , and nurses can assist and motivate patients during follow-up periods . Helping patients to quit smoking and control other risk-factor modifications ( ie , high blood pressure and lipid levels ) also has high priority in daily practice of the vascular nurse . This prospect i ve study will illustrate the results of prescribed home-based exercise training by a vascular nurse on the maximum painless walking distance for patients with IC and will be applied to subgroups of vascular pathology People with lower extremity peripheral artery disease ( PAD ) have greater functional impairment and faster functional decline than those without PAD . We describe methods for the Group Oriented Arterial Leg Study ( GOALS ) , an ongoing r and omized controlled clinical trial design ed to determine whether a Group-Mediated Cognitive Behavioral ( GMCB ) intervention improves functional performance in PAD participants , compared to a health education control condition . In GOALS , PAD participants were r and omized to either an intervention or a health education control condition in a parallel design . Both conditions consist of weekly group sessions with other PAD participants . In the intervention , cognitive behavioral techniques are used to assist participants in setting and adhering to home-based walking exercise goals . Participants are encouraged to walk for exercise at home at least 5 days/week . In the control condition , participants receive lectures on health-related topics . After 6 months of on-site weekly sessions , participants are transitioned to telephone follow-up for another 6 months . Participants in the intervention are asked to continue home walking exercise .  The primary outcome is change in six-minute walk performance between baseline and six-month follow-up . Secondary outcomes include change in six-minute walk performance at 12-month follow-up , and change in treadmill walking performance , the Walking Impairment Question naire , quality of life , and physical activity at six and 12-month follow-up . In conclusion , if our group-mediated cognitive behavioral intervention is associated with improved walking performance in individuals with PAD , results will have major public health implication s for the large and growing number of people with PAD PURPOSE In a pilot study , the hypothesis was tested that a home-based walking exercise program with structured coaching would improve walking performance and adherence in patients with intermittent claudication ( IC ) . METHODS Thirty-one IC patients with a rest ankle-brachial pressure index < 0.90 started a 24-wk walking program in the home environment . They were coached according to the Health Counseling Model ( HCM ) . Patients were instructed to walk at least 9 bouts.wk-1 and to walk through the pain . The main effect measures were pain-free ( initial claudication distance ( ICD ) ) and maximum walking distance ( absolute claudication distance ( ACD ) ) measured with a grade d treadmill test , a corridor exercise test , a  walking-diary  , and the score on the Walking Impairment Question naire ( WIQ ) . RESULTS Twenty-four participants completed the program . The reported walking frequency was 7.4 times.wk-1 . The average ICD improved from 289 m ( 95 % CI , 209 - 369 ) to 347 m ( 95 % CI , 244 - 449 ) ( P < 0.05 ) and from 241 m ( 95 % CI , 171 - 310 ) to 373 m ( 95 % CI , 273 - 472 ) on the treadmill and the corridor test , respectively . The average ACD improved from 490 m ( 95 % CI , 397 - 583 ) to 544 m ( 95 % CI , 438 - 650 ) and from 564 m ( 95 % CI , 412 - 717 ) to 726 m ( 95 % CI , 546 - 906 ) ( P < 0.01 ) on the treadmill and the corridor test , respectively . The average maximum distance reported in the walking-diary improved from 957 m ( 95 % CI , 291 - 1623 ) to 1294 m ( 95 % CI , 646 - 1941 ) . The score of the walking distance on the WIQ improved from 57 % ( 95 % CI , 42 - 71 % ) to 60 % ( 95 % CI , 46 - 74 % ) . CONCLUSION IC patients improved their average ICD and ACD . The walking exercise program in the home environment with coaching according to the HCM seems a promising intervention to be tested in a r and omized controlled trial OBJECTIVES To evaluate an unsupervised home-based exercise programme for physiological , functional , and quality of life impact in patients with symptomatic peripheral arterial disease . DESIGN Prospect i ve cohort with exercise intervention . MATERIAL S Human performance laboratory with non-invasive haemodynamic assessment facilities . METHODS Forty-seven patients with symptomatic peripheral arterial disease ( mean age 67.6+/-7 years , 33 males ) participated in an unsupervised home-based exercise programme .  Heart rate ( HR ) , ankle brachial blood pressure index ( ABPI ) , leg blood flow ( BF ) , and blood lactate were measured before and after a grade d treadmill walk at baseline and after the 12-week exercise programme .  Maximum walking distance ( MWD ) during the treadmill walk was measured at baseline and 12 weeks . Exercise compliance , functional parameters , and quality of life ( VascuQoL ) were assessed by question naire . RESULTS MWD , leg BF , and VascuQoL scores increased significantly , while resting HR , exercise HR , and end of walk rate-pressure-product ( RPP ) decreased significantly after 12 weeks . Exercise compliance was significantly correlated with increase in MWD ( r=0.89 , p<0.001 ) and QOL score improvement ( r=0.61 , p<0.001 ) . CONCLUSIONS This supported but unsupervised exercise programme generated improvements in walking distance and leg blood flow without detectable increases in cardiorespiratory work . Exercise compliance is related to MWD and VascuQoL score in a dose-response manner PURPOSE This study was performed to test the effectiveness of a formal supervised exercise program against a home-based exercise program for both walking ability and quality of life endpoints . METHODS Patients with arterial claudication were r and omized to either a 12-week supervised exercise program ( SUPEX ) with weekly lectures relating to peripheral vascular disease or to a home exercise group ( HOMEX ) who attended an identical lecture program and received weekly exercise instruction . The study population included 29 men and 26 women , with a mean age of 69.1 + /- 8.1 years . Forty-seven patients completed the 12-week program , 46 were available for testing at completion , and 38 for 6-month testing . Claudication pain time ( CPT ) and maximum walking time ( MWT ) on a progressive treadmill exercise test were assessed at baseline , program completion , and 6 months . The Medical Outcomes Study Short Form-36 ( SF-36 ) was administered at these intervals to assess effects on quality of life . RESULTS Each group improved ( p < 0.001 ) in both CPT and MWT at the completion of the 12-week program , which was sustained at the 6-month follow-up . Increase in HOMEX CPT from baseline ( 3.6 + /- 2.73 minutes ) to 6-month follow-up ( 6.6 + /- 3.17 minutes ) was less than for the SUPEX group ( 3.8 + /- 2.74 to 11.2 + /- 4.02 minutes , respectively ) ; similar results were obtained for MWT . At both completion and 6 months , there was a significant intergroup difference for CPT and MWT ( p < 0.004 ) favoring SUPEX . For both groups , measures of health perception based on the SF-36 demonstrated improvement ( p < 0.002 ) in Physical Function Subscale , Bodily Pain Subscale , and Physical Composite Score . There were no between-group differences on the subsets of the SF-36 at the three assessment intervals . CONCLUSIONS Supervised exercise programs provide superior increased walking ability in the noninterventional therapy of arterial claudication , and both supervised and home based exercise therapy result in improved SF-36 functional measures . The lack of intergroup differences in these measures may be a result of the high degree of interaction with healthcare providers in the HOMEX group . Although a supervised program results in optimal walking benefits , a highly structured home-based program provides similar functional improvement and may be a satisfactory alternative for patients with lesser walking requirements In a non-r and omized , open-label study results after a structured  institution-based peripheral arterial occlusive disease ( PAD ) rehabilitation program  were compared with the results of training at home . Three groups were compared : group 1 ( n = 19 ) PAD rehabilitation ; group 2 ( n = 19 ) PAD rehabilitation + clopidogrel 75 mg once daily ; group 3 ( n = 21 ) home-based training .  The training period was 3 months for all groups , which was followed by a 3-month observation phase ( without prescribed training ) . The rehabilitation program consisted of 3 training hours per week . Background variables , demographics , and baseline claudication distances were comparable between groups . After 3 months of training the absolute claudication distances ( ACD ) improved by 82.7 % , 131.4 % , and 5.4 % for groups 1 , 2 and 3 . The initial claudication distances ( ICD ) changed by 163.8 % , 200.6 % , and 44.4 % , respectively . All changes , except the ACD result for group 3 , were statistically significant ( p 0.05 ) . Structured training groups ( 1 and 2 ) performed significantly better than group 3 ( p 0.05 ) . When results from groups 1 and 2 were pooled , ACDs changed from 493.3 218.1 to 1026.0 468.9 m , 546.0 378.8 m [ 95 % CI 417.8 - 674.2 m ] ; p 0.05 . ICDs improved from 175.3 110.8 m to 493.1 326.7 m , 320.8 315.9 m [ 95 % CI 213.9 - 427.7 m ] ; p 0.05 . The difference between the pooled mean results of the structured training groups and the results of group 3 amounted to 474.3 m [ 95 % CI 270.2 - 678.4 m ] and 242.4 m [ 95 % CI 99.0 - 385.7 m ] , for ACD and ICD , respectively . Structured , supervised PAD rehabilitation is a highly efficacious treatment for intermittent claudication and may be regarded as the present gold st and ard among conservative treatment options PURPOSE This study was performed to test the efficacy of a supervised , hospital-based exercise program compared with a home-based exercise program involving minimal supervision , for both walking ability and quality of life measures in patients with exercise-limiting intermittent leg claudication . METHODS Twenty-one patients were assigned r and omly to 12 weeks of supervised exercise or to a home-based exercise group . After 12 weeks the participants in the supervised group transitioned to a home-based program . Both groups were then reevaluated at the end of 24 weeks . The initial claudication distance ( ICD ) and absolute claudication distance ( ACD ) on progressive treadmill exercise was measured at baseline , 12 weeks , and 24 weeks . Additionally , self-reported quality of life status was evaluated using the MOS SF-36 question naire . RESULTS Each group improved ( P < 0.01 ) ACD from baseline to 12 weeks , which was sustained at the 24-week follow-up . Both groups experienced similar long-term improvements ( P < 0.05 ) in ACD ( 521.5 + /- 253.4 meters to 741.9 + /- 365.6 meters for the supervised group , 532.2 + /- 263.5 meters to 715.0 + /- 394.4 meters in the home group , P not significant , between groups ) . The supervised group experienced a greater improvement ( P < 0.01 ) in the ICD after 12 weeks than the home group but not at 24 weeks . The on-site group also experienced significant improvements in ICD after 24 weeks ( P < 0.05 ) . Neither group manifested an improvement in self-reported physical function or mental health as assessed by the MOS SF-36 . CONCLUSION A structured exercise program was more effective in improving the ICD over a 24-week period than a less formal , home-based program . However , if patients are screened properly and receive adequate instruction , a home-based program can be a safe , low-cost alternative providing similar long-term ( 24 weeks ) exercise benefits in ACD This article introduces the approach of GRADE to rating  quality of evidence .  GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence Arm cranking is a useful alternative exercise modality for improving walking performance in patients with intermittent claudication ; however , the mechanisms of such an improvement are poorly understood . The main aim of the present study was to investigate the effects of arm-crank exercise training on lower-limb O2 delivery in patients with intermittent claudication . A total of 57 patients with intermittent claudication ( age , 70+/-8 years ; mean+/-S.D. ) were r and omized to an arm-crank exercise group or a non-exercise control group . The exercise group trained twice weekly for 12 weeks . At baseline and 12 weeks , patients completed incremental tests to maximum exercise tolerance on both an arm-crank ergometer and a treadmill .  Respiratory variables were measured breath-by-breath to determine peak VO2 ( O2 uptake ) and ventilatory threshold . Near-IR spectroscopy was used in the treadmill test to determine changes in calf muscle StO2 ( tissue O2 saturation ) . Patients also completed a square-wave treadmill-walking protocol to determine VO2 kinetics . A total of 51 patients completed the study . In the exercise group , higher maximum walking distances ( from 496+/-250 to 661+/-324 m ) and peak VO2 values ( from 17.2+/-2.7 to 18.2+/-3.4 ml.kg-1 of body mass.min-1 ) were recorded in the incremental treadmill test ( P<0.05 ) . After training , there was also an increase in time to minimum StO2 ( from 268+/-305 s to 410+/-366 s ) , a speeding of VO2 kinetics ( from 44.7+/-10.4 to 41.3+/-14.4 s ) and an increase in submaximal StO2 during treadmill walking ( P<0.05 ) . There were no significant changes in the control group . The results suggest that the improvement in walking performance after arm-crank exercise training in patients with intermittent claudication is attributable , at least in part , to improved lower-limb O2 delivery BACKGROUND Exercise training reduces walking disability in peripheral arterial disease ( PAD ) . This non-r and omized study evaluates the effects on walking ability and hemodynamic parameters of a novel approach to home-based rehabilitation , the test in -train out program ( Ti-To ) , compared with the traditional home-based free walking exercise ( Tr-E ) . METHODS AND RESULTS A total of 143 patients with claudication ( 117 men , average age 68+/-10 years ) , were included in a Ti-To ( n=83 ) or Tr-E program ( n=60 ) . Evaluations , which were carried out upon entry and at 1 , 2 , 3 , 4 and 6 months , included : self-reported claudication , walking ability ( ie , absolute claudication distance , pain threshold speed ) , resting/exercise heart rates ( HR ) , systolic/diastolic brachial pressure ( SBP/DBP ) , ankle pressure ( AP ) , ankle-brachial index ( ABI ) . Ti-To involved 2 daily 10-min home walking sessions at maximal asymptomatic speed and the patient attending monthly check-ups at hospital . Tr-E involved 20 - 30 min of daily walking at self-selected speeds up to pain tolerance . A total of 126 patients ( Ti-To , n=74 ; Tr-E , n=52 ) completed the program . Ti-To induced better relief from claudication ( p=0.001 ) . Functional parameters improved significantly for both groups ( p<0.0001 ) with significant intergroup difference for Ti-To ( p<0.0001 ) . SBP and exercise HR decreased significantly in both groups , with Ti-To improving resting HR ( p=0.0002 ) , DBP ( p=0.003 ) , lowest AP worse limb ( p=0.004 ) and ABI worse limb ( p=0.0002 ) . CONCLUSIONS In patients with PAD , a Ti-To program had more positive effects on perceived claudication , and functional and hemodynamic parameters than did a Tr-E program
target: Nevertheless , there was " low-level " evidence that HEPs can improve walking capacity and quality of life in patients with intermittent claudication when compared with baseline or in comparison to usual care/observation control .
  In addition , improvements with  HEPs  may be inferior to those evoked by supervised exercise training .
background: We aim ed to conduct a systematic review of the evidence for structured , home-based exercise programmes ( HEPs ) in patients with intermittent claudication .