title: A tutorial on pilot studies: the what, why and how The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. Nuts and bolts of conducting feasibility studies. Pragmatic exercise intervention in people with mild to moderate multiple sclerosis: a randomised controlled feasibility study. Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework The feasibility and short-term benefits of Blue Prescription: a novel intervention to enable physical activity for people with multiple sclerosis Feasibility and effects of a group kickboxing program for individuals with multiple sclerosis: a pilot report. CONSORT 2010 statement: extension to randomised pilot and feasibility trials CONSORT 2010 statement: extension to randomised pilot and feasibility trials Design and analysis of pilot studies: recommendations for good practice. A task-oriented circuit training in multiple sclerosis: a feasibility study Long-term benefits of exercising on quality of life and fatigue in multiple sclerosis patients with mild disability: a pilot study Cost effectiveness of a pragmatic exercise intervention (EXIMS) for people with multiple sclerosis: economic evaluation of a randomised controlled trial Exercise in the community for people with minimal gait impairment due to MS: an assessor-blind randomized controlled trial Effect of Aerobic Training on Walking Capacity and Maximal Exercise Tolerance in Patients With Multiple Sclerosis: A Randomized Crossover Controlled Study Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial Bridging the goal intention–action gap in rehabilitation: a study of if-then implementation intentions in neurorehabilitation Pilot randomized trial of progressive resistance exercise augmented by neuromuscular electrical stimulation for people with multiple sclerosis who use walking aids. Exercise for multiple sclerosis: a single-blind randomized trial comparing three exercise intensities Progressive resistance training did not improve walking but can improve muscle performance, quality of life and fatigue in adults with multiple sclerosis: a randomized controlled trial Randomized controlled pilot study of customized pamphlets to promote physical activity and symptom self-management in women with multiple sclerosis Treadmill training for individuals with multiple sclerosis: a pilot randomised trial Motivational interviewing may improve exercise experience for people with multiple sclerosis: A small randomized trial. Results of a feasibility randomised controlled study of the guidelines for exercise in multiple sclerosis project. Pilates for people with multiple sclerosis who use a wheelchair: feasibility, efficacy and participant experiences
abstract: Pilot studies for phase III trials - which are comparative r and omized trials design ed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas . Also commonly know as " feasibility " or " vanguard " studies , they are design ed to assess the safety of treatment or interventions ; to assess recruitment potential ; to assess the feasibility of international collaboration or coordination for multicentre trials ; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large , expensive full-scale study , and in fact are an almost essential pre-requisite . Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies . The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including : 1 ) the general reasons for conducting a pilot study ; 2 ) the relationships between pilot studies , proof-of-concept studies , and adaptive design s ; 3 ) the challenges of and misconceptions about pilot studies ; 4 ) the criteria for evaluating the success of a pilot study ; 5 ) frequently asked questions about pilot studies ; 7 ) some ethical aspects related to pilot studies ; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format Feasibility and pilot studies play an important role in the preliminary planning of a proposed full-size r and omized clinical trial  ( RCT ) . In essence , feasibility studies are used to help develop trial interventions or outcome measures , whereas pilot studies replicate , in miniature , a planned full-size RCT . However , the terms used for these preliminary studies are sometimes considered synonymous , and in practice may overlap considerably or be combined . The important issue is not the distinction between these : the important distinction is between such preliminary studies and a proper RCT . J Orthop Sports Phys Ther 2014;44(8):555–558 . Many factors can affect the successful implementation and validity of intervention studies . A primary purpose of feasibility and pilot studies is to assess the potential for successful implementation of the proposed main intervention studies and to reduce threats to the validity of these studies . This article describes a typology to guide the aims of feasibility and pilot studies design ed to support the development of r and omized controlled trials and provides an example of the studies underlying the development of one rehabilitation trial . The purpose of most feasibility and pilot studies should be to describe information and evidence related to the successful implementation and validity of a planned main trial . Null hypothesis significance testing is not appropriate for these studies unless the sample size is properly powered . The primary tests of the intervention effectiveness hypotheses should occur in the main study , not in the studies that are serving as feasibility or pilot studies BACKGROUND People with Multiple Sclerosis ( PwMS ) are less physically active than the general population and pragmatic approaches design ed to equip them with the skills and confidence to participate in long-term physical activity are required . OBJECTIVE The objective of this study was to determine the feasibility of a pragmatic exercise intervention in PwMS . METHODS A voluntary sample of 30 PwMS ( male n = 4 , female n = 26 ; mean age = 40 years ; range = 24 - 49 years ) , with mild to moderate disability ( EDSS ≤ 5.5 ) , were recruited from eligible participants attending outpatient clinics . A total of 28 participants were r and omised to a 10 week pragmatic exercise intervention ( 2 × supervised and 1 × home-based session per week ) or usual care . Clinical , functional and quality of life ( MSQoL-54 ) outcomes were assessed at baseline , immediately and 3 months after the intervention . RESULTS Attrition was low ( 2 participants lost to immediate follow-up and 4 participants lost to 3 month follow-up ) , with high compliance rates ( > 75 % of all sessions ) . The intervention group achieved progression of exercise volume ( 24.3 ± 7.0 to 30.9 ± 5.5 min per session ) , intensity ( 60.4 ± 8.8 to 67.7 ± 6.9 % HR max ) and training impulse ( min × average HR = training impulse/load [ arbitrary units ; AU ] ) ( 2600 ± 1105 to 3210 ± 1269AU ) during the intervention , whilst significantly increasing(P = 0.050 ) their physical composite score ( MSQOL-54 ) at 10 weeks and readiness to exercise ( P = 0.003 ) at 3 months compared with usual care . CONCLUSION This pragmatic intervention was feasible for PwMS , but further research is needed to assess its long-term impact on physical activity behaviour Background The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame . Despite an increase in research into the benefits of exercise in people with multiple sclerosis ( PwMS ) , no trial has reported detailed data on effective recruitment strategies for large-scale r and omised controlled trials . The main purpose of this report is to provide a detailed outline of recruitment strategies , rates and estimated costs in the Exercise Intervention for Multiple Sclerosis ( ExIMS ) trial to identify best practice s for future trials involving multiple sclerosis ( MS ) patient recruitment . Methods The ExIMS research ers recruited 120 PwMS to participate in a 12-week exercise intervention .  Participants were r and omly allocated to either  exercise or usual-care control groups . Participants were sedentary , aged 18–65 years and had Exp and ed Disability Status Scale scores of 1.0–6.5 . Recruitment strategies included attendance at MS outpatient clinics , consultant mail-out and trial awareness-raising activities . Results A total of 120 participants were recruited over the course of 34 months . To achieve this target , 369 potentially eligible and interested participants were identified . A total of 60 % of participants were recruited via MS clinics , 29.2 % from consultant mail-outs and 10.8 % through trial awareness . The r and omisation yields were 33.2 % , 31.0 % and 68.4 % for MS clinic , consultant mail-outs and trial awareness strategies , respectively . The main reason for in eligibility was being too active ( 69.2 % ) , whilst for eligible participants the most common reason for non-participation was the need to travel to the study site ( 15.8 % ) . Recruitment via consultant mail-out was the most cost-effective strategy , with MS clinics being the most time-consuming and most costly . Conclusions To reach recruitment targets in a timely fashion , a variety of methods were employed . Although consultant mail-outs were the most cost-effective recruitment strategy , use of this method alone would not have allowed us to obtain the predetermined number of participants in the required time period , thus leading to costly extensions of the project or failure to reach the number of participants required for sufficient statistical power . Thus , a multifaceted approach to recruitment is recommended for future trials . Trial registration International St and ard R and omised Controlled Trial Registry number : IS RCT N41541516 ; date registered : 5 February 2009 The Guidelines for Exercise in Multiple Sclerosis ( GEMS ) program is a r and omized controlled trial ( RCT ) examining the feasibility and efficacy of a home-based exercise training program based on recent physical activity guidelines and principles of behavior change for improving symptoms and health-related quality of life ( HRQOL ) in adults with multiple sclerosis ( MS ) . The primary aim is to assess program feasibility in the four domains of process ( e.g. , recruitment , retention , and adherence ) , re sources ( e.g. , communication , staff requirements , and monetary costs ) , management ( e.g. , time and accuracy in data collection /entry , and reporting of adverse events ) and scientific outcomes ( e.g. , safety , burden , participant feedback and efficacy/ outcomes ) . The trial will recruit individuals with mild-to-moderate MS-related disability across the United States who will be r and omized into intervention or waitlist control conditions . All participants will complete home-based assessment s ( including wearing an accelerometer for 7 days and completion of a question naire booklet ) prior to and upon completion of the 4-month program . Participants in the intervention will receive a 4-month home-based exercise program emphasizing aerobic and resistance training . Participants will be provided with exercise equipment , a DVD , a manual and a log-book . The exercise program will be supplemented with periodic newsletters in the mail highlighting principles of behavior change , and video-chats with an exercise specialist to provide motivation and social accountability . This trial serves to inform development of Phase II and III RCTs which can determine the actual efficacy and effectiveness of home-based exercise based on the MS-specific physical activity guidelines for improving symptoms and HRQOL We describe a framework for defining  pilot and feasibility studies  focusing on studies conducted in preparation for a r and omised controlled trial . To develop the framework , we undertook a Delphi survey ; ran an open meeting at a trial methodology conference ; conducted a review of definitions outside the health research context ; consulted experts at an international consensus meeting ; and review ed 27 empirical pilot or feasibility studies . We initially adopted mutually exclusive definitions of pilot and feasibility studies . However , some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions . Their viewpoint was supported by definitions outside the health research context , the use of the terms ‘ pilot ’ and ‘ feasibility ’ in the literature , and participants at the international consensus meeting . In our framework , pilot studies are a subset of feasibility studies , rather than the two being mutually exclusive . A feasibility study asks whether something can be done , should we proceed with it , and if so , how . A pilot study asks the same questions but also has a specific design feature : in a pilot study a future study , or part of a future study , is conducted on a smaller scale . We suggest that to facilitate their identification , these studies should be clearly identified using the terms ‘ feasibility ’ or ‘ pilot ’ as appropriate . This should include feasibility studies that are largely qualitative ; we found these difficult to identify in electronic search es because research ers rarely used the term ‘ feasibility ’ in the title or abstract of such studies . Investigators should also report appropriate objectives and methods related to feasibility ; and give clear confirmation that their study is in preparation for a future r and omised controlled trial design ed to assess the effect of an intervention Purpose : Participation in physical activity for people with Multiple sclerosis ( MS ) is important but can be difficult to sustain long-term . Facilitators for long-term adherence include choice over activity and control over level of engagement , coupled with support , advice and encouragement from a physiotherapist . This is the basis of Blue Prescription , a novel physiotherapy approach aim ed at optimising long-term adherence with physical activity . We evaluated the feasibility and short-term benefits of Blue Prescription in people with MS . Methods : Twenty-seven people with MS ( mean age : 51 ± 11 years , with a range of MS type and disability ) were assessed at baseline and immediately post-intervention with the MS Impact Scale , MS Self-efficacy Scale , and European Quality of Life Question naire . Change in outcomes were analysed with Wilcoxon signed ranks tests . Results : All participants , irrespective of level of disability , were able to choose a physical activity and to engage in it . The physical component MS Impact Scale score significantly improved by a median change of 6.5 ( 95 % CI = −10.5 to −2.0 ; p = 0.007 ; effect size = 0.38 ) . There were no other significant changes in outcomes . Conclusion : Blue Prescription appears feasible and potentially beneficial , particularly in reducing the negative impacts of MS upon individuals , and thus warrants further evaluation . Implication s for Rehabilitation Facilitators for long-term adherence for disabled people include choice over activity and control over level of engagement , coupled with support , advice and encouragement from a physiotherapist . Blue Prescription is a physiotherapy approach aim ed at optimising long-term adherence with physical activity for people with multiple sclerosis . Blue Prescription appears to reduce the negative impacts of multiple sclerosis upon individuals BACKGROUND AND PURPOSE Balance and mobility impairments are common in persons with multiple sclerosis ( MS ) . The primary purpose of this pilot program was to evaluate the feasibility and the effects of group kickboxing on balance and mobility in individuals with MS . METHODS Four individuals with relapsing-remitting or secondary progressive MS participated in a group kickboxing program two times per week for 8 weeks . Outcome measures included the Berg Balance Scale ( BBS ) , Dynamic Gait Index ( DGI ) , Timed Up and Go ( TUG ) , walking speed and the Activities Specific Balance Confidence Scale ( ABC ) . RESULTS Following training , 3 of 4 participants had improvements in BBS performance . All participants demonstrated improvements in the DGI . Changes in the TUG , ABC , and walking speed were more variable . CONCLUSION Group kickboxing appears to be a feasible exercise activity for individuals with MS and may lead to improvement in select measures of balance . Further investigation may be warranted The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement is a guideline design ed to improve the transparency and quality of the reporting of r and omised controlled trials ( RCTs ) . In this article we present an extension to that statement for r and omised pilot and feasibility trials conducted in advance of a future definitive RCT . The checklist applies to any r and omised study in which a future definitive RCT , or part of it , is conducted on a smaller scale , regardless of its design ( eg , cluster , factorial , crossover ) or the terms used by authors to describe the study ( eg , pilot , feasibility , trial , study ) . The extension does not directly apply to internal pilot studies built into the design of a main trial , non-r and omised pilot and feasibility studies , or phase II studies , but these studies all have some similarities to r and omised pilot and feasibility studies and so many of the principles might also apply . The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct . We followed recommended good practice to develop the extension , including carrying out a Delphi survey , holding a consensus meeting and research team meetings , and piloting the checklist . The aims and objectives of pilot and feasibility r and omised studies differ from those of other r and omised trials . Consequently , although much of the information to be reported in these trials is similar to those in r and omised controlled trials ( RCTs ) assessing effectiveness and efficacy , there are some key differences in the type of information and in the appropriate interpretation of st and ard CONSORT reporting items . We have retained some of the original CONSORT statement items , but most have been adapted , some removed , and new items added . The new items cover how participants were identified and consent obtained ; if applicable , the prespecified criteria used to judge whether or how to proceed with a future definitive RCT ; if relevant , other important unintended consequences ; implication s for progression from pilot to future definitive RCT , including any proposed amendments ; and ethical approval or approval by a research review committee confirmed with a reference number . This article includes the 26 item checklist , a separate checklist for the abstract , a template for a CONSORT flowchart for these studies , and an explanation of the changes made and supporting examples . We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials . Editor ’s note : In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement is a guideline design ed to improve the transparency and quality of the reporting of r and omised controlled trials ( RCTs ) . In this article we present an extension to that statement for r and omised pilot and feasibility trials conducted in advance of a future definitive RCT . The checklist applies to any r and omised study in which a future definitive RCT , or part of it , is conducted on a smaller scale , regardless of its design ( eg , cluster , factorial , crossover ) or the terms used by authors to describe the study ( eg , pilot , feasibility , trial , study ) . The extension does not directly apply to internal pilot studies built into the design of a main trial , non-r and omised pilot and feasibility studies , or phase II studies , but these studies all have some similarities to r and omised pilot and feasibility studies and so many of the principles might also apply . The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct . We followed recommended good practice to develop the extension , including carrying out a Delphi survey , holding a consensus meeting and research team meetings , and piloting the checklist . The aims and objectives of pilot and feasibility r and omised studies differ from those of other r and omised trials . Consequently , although much of the information to be reported in these trials is similar to those in r and omised controlled trials ( RCTs ) assessing effectiveness and efficacy , there are some key differences in the type of information and in the appropriate interpretation of st and ard CONSORT reporting items . We have retained some of the original CONSORT statement items , but most have been adapted , some removed , and new items added . The new items cover how participants were identified and consent obtained ; if applicable , the prespecified criteria used to judge whether or how to proceed with a future definitive RCT ; if relevant , other important unintended consequences ; implication s for progression from pilot to future definitive RCT , including any proposed amendments ; and ethical approval or approval by a research review committee confirmed with a reference number . This article includes the 26 item checklist , a separate checklist for the abstract , a template for a CONSORT flowchart for these studies , and an explanation of the changes made and supporting examples . We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials . Editor ’s note : In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites Pilot studies play an important role in health research , but they can be misused , mistreated and misrepresented . In this paper we focus on pilot studies that are used specifically to plan a r and omized controlled trial ( RCT ) . Citing examples from the literature , we provide a method ological framework in which to work , and discuss reasons why a pilot study might be undertaken . A well-conducted pilot study , giving a clear list of aims and objectives within a formal framework will encourage method ological rigour , ensure that the work is scientifically valid and publishable , and will lead to higher quality RCTs . It will also safeguard against pilot studies being conducted simply because of small numbers of available patients Background The aim of this study was to evaluate the safety , feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training ( TOCT ) in a sample of multiple sclerosis ( MS ) subjects on walking competency , mobility , fatigue and health-related quality of life ( HRQoL ) . Methods 24 MS subjects ( EDSS 4.89 ± 0.54 , 17 female and 7 male , 52.58 ± 11.21 years , MS duration 15.21 ± 8.68 years ) have been enrolled and r and omly assigned to 2 treatment groups : ( i ) experimental group received 10 TOCT sessions over 2 weeks ( 2 hours/each session ) followed by a 3 months home exercise program , whereas control group did not receive any specific rehabilitation intervention . A feasibility patient-reported question naire was administered after TOCT . Functional outcome measures were : walking endurance ( Six Minute Walk Test ) , gait speed ( 10 Meter Walk Test ) , mobility ( Timed Up and Go test ) and balance ( Dynamic Gait Index ) . Furthermore , self-reported question naire of motor fatigue ( Fatigue Severity Scale ) , walking ability ( Multiple Sclerosis Walking Scale – 12 ) and health-related quality of life ( Multiple Sclerosis Impact Scale – 29 ) were included . Subjects ’ assessment s were delivered at baseline ( T0 ) , after TOCT ( T1 ) and 3 months of home-based exercise program ( T2 ) . Results After TOCT subjects reported a positive global rating on the received treatment . At 3 months , we found a 58.33 % of adherence to the home-exercise program . After TOCT , walking ability and health-related quality of life were improved ( p < 0.05 ) with minor retention after 3 months . The control group showed no significant changes in any variables . Conclusions This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments ; moreover it might improve walking abilities . Trial registration Objective : To determine if exercise benefits patients with multiple sclerosis . Design : R and omized controlled trial . Setting s : Participants exercised at home and also attended exercise classes held in a hospital physiotherapy gym . Subjects : Thirty patients , diagnosed and independently mobile , were recruited in the Dublin area . Intervention : For three months , classes were held twice-weekly and participants exercised independently once-weekly . The control group was monitored monthly and management remained unchanged . Measurements : Measurements were taken at baseline , three and six months . The Modified Fatigue Impact Scale ( MFIS ) , Multiple Sclerosis Impact Scale-29 ( MSIS-29 ) and Functional Assessment of Multiple Sclerosis ( FAMS ) were used to measure fatigue and quality of life ( QOL ) . Heart rate ( HR ) and the Borg 's Rating of Perceived Exertion ( RPE ) were recorded during an incremental exercise test . The change from baseline scores between groups was compared using the Mann — Whitney U-test . Results : Twenty-four participants completed the programme ( n = 12 in each group ) . Based on the change in scores at three months , the exercise group had significantly greater improvements in exercise capacity ( HR : —14 [ -18.5 , -2.5 ] versus 0.5 [ -4 , 5.5 ] , P= 0.009 ) , QOL ( FAMS : 23 [ 9.5 , 42.5 ] versus -3.5 [ -16 , 5 ] , P=0.006 ) and fatigue ( MFIS : -13 [ -20 , -3 ] versus 1 [ -4 , 4.5 ] , P=0.02 ) . At six months , the difference in change scores remained significant for FAMS ( 19 [ 14 , 31 ] versus -4.5 [ -25 , 8 ] , P=0.002 ) and MFIS ( -8.5 [ -19.5 , -1 ] versus 0.5 [ -2.5 , 6.5 ] , P=0.02 ) only . Conclusions : A three-month exercise programme improved participants ' exercise capacity , QOL and fatigue , with the improvements in QOL and fatigue lasting beyond the programme Background : Exercise is a safe , non-pharmacological adjunctive treatment for people with multiple sclerosis but cost-effective approaches to implementing exercise within health care setting s are needed . Objective : The objective of this paper is to assess the cost effectiveness of a pragmatic exercise intervention in conjunction with usual care compared to usual care only in people with mild to moderate multiple sclerosis . Methods : A cost-utility analysis of a pragmatic r and omised controlled trial over nine months of follow-up was conducted . A total of 120 people with multiple sclerosis were r and omised ( 1:1 ) to the intervention or usual care . Exercising participants received 18 supervised and 18 home exercise sessions over 12 weeks . The primary outcome for the cost utility analysis was the incremental cost per quality -adjusted life year ( QALY ) gained , calculated using utilities measured by the EQ-5D question naire . Results : The incremental cost per QALY of the intervention was £ 10,137 per QALY gained compared to usual care . The probability of being cost effective at a £ 20,000 per QALY threshold was 0.75 , rising to 0.78 at a £ 30,000 per QALY threshold . Conclusion : The pragmatic exercise intervention is highly likely to be cost effective at current established thresholds , and there is scope for it to be tailored to particular sub-groups of patients or services to reduce its cost impact Background : While there is an increasing body of evidence supporting the efficacy of exercise in people with multiple sclerosis ( MS ) , additional information on the effectiveness of combining aerobic and resistance training , and yoga is required . Objectives : This study evaluated the effectiveness of community exercise interventions for people with MS having minimal gait impairment . Methods : A multi-centred , block-r and omised , assessor-blinded , controlled trial was conducted . Participants were r and omised in groups of eight to physiotherapist (PT)-led exercise ( n = 80 ) , yoga ( n = 77 ) , fitness instructor (FI)-led exercise ( n = 86 ) and they took part in weekly community-based group exercise sessions . Those in the control group were asked not to change of their exercise habits ( n = 71 ) . The primary outcome was the Multiple Sclerosis Impact Scale ( MSIS ) 29v2 physical component , measured before and after the 10-week intervention . Secondary outcomes were the MSIS 29v2 psychological component , the Modified Fatigue Impact Scale ( MFIS ) and the 6-Minute Walk Test ( 6MWT ) . Results : The group x time interaction approached significance for the MSIS-29v2 physical component ( f = 2.48 , p = 0.061 ) and MFIS total ( f = 2.50 , p = 0.06 ) , and it was significant for the MFIS physical subscale ( f = 4.23 , p = 0.006 ) . All three exercise interventions led to a statistically significant improvement on the MSIS-29 psychological component and both the MFIS total and physical subscales , which were greater than the control ( p < 0.05 ) . Only the PT-led and FI-led interventions significantly improved the MSIS-29 physical and 6MWT to levels greater than the control ( p < 0.05 ) . Conclusions : This study provides evidence for the positive effect of exercise on the physical impact of MS and fatigue . The group nature of the classes may have contributed to the positive effects seen on the psychological impact of MS Background and Purpose Physical deconditioning is involved in the impaired exercise tolerance of patients with multiple sclerosis ( MS ) , but data on the effects of aerobic training ( AT ) in this population are scanty . The purpose of this study was to compare the effects of an 8-week AT program on exercise capacity — in terms of walking capacity and maximum exercise tolerance , as well as its effects on fatigue and health-related quality of life — as compared with neurological rehabilitation ( NR ) in subjects with MS . Subjects and Methods Nineteen subjects ( 14 female , 5 male ; mean age [X̄±SD]=41±8 years ) with mild to moderate disability secondary to MS participated in a r and omized crossover controlled study . Eleven subjects ( 8 female , 3 male ; mean age [X̄±SD]=44±6 years ) completed the study . Results After AT , but not NR , the subjects ’ walking distances and speeds during a self-paced walk were significantly improved , as were their maximum work rate , peak oxygen uptake , and oxygen pulse during cardiopulmonary exercise tests . The increases in peak oxygen uptake and maximum work rate , but not in walking capacity , were significantly higher after AT , as compared with after NR . Additionally , the subjects who were most disabled tended to benefit more from AT . There were no differences between AT and NR in effects on fatigue , and the results showed that AT may have partially affected health-related quality of life . Discussion and Conclusion The results suggest that AT is more effective than NR in improving maximum exercise tolerance and walking capacity in people with mild to moderate disability secondary to MS Objective : To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis : ( A ) a home-based exercise program targeting physiological risk factors ; ( B ) an educational program targeting behavioral risk factors ; and ( C ) a combined exercise- and -education program targeting both factors . Design : R and omized controlled trial . Setting : Home-based training with assessment s at research laboratory . Participants : A total of 103 individuals inquired about the investigation . After screening , 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45–75 years volunteered for the investigation . A total of 34 participants completed post assessment following the 12-week intervention . Intervention : Participants were r and omly assigned into one of four conditions : ( 1 ) wait-list control ( n = 9 ) ; ( 2 ) home-based exercise ( n = 11 ) ; ( 3 ) education ( n = 9 ) ; or ( 4 ) a combined exercise and education ( n = 8) group . Measures : Before and after the 12-week interventions , participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey . Participants completed falls diaries during the three-months postintervention . Results : A total of 34 participants completed postintervention testing . Procedures and processes were found to be feasible . Overall , fall risk scores were lower in the exercise groups ( 1.15 SD 1.31 ) compared with the non-exercise groups ( 2.04 SD 1.04 ) following the intervention ( p < 0.01 ) . There was no group difference in fall prevention behaviors ( p > 0.05 ) . Conclusions : Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted . A total of 108 participants would be needed in a larger r and omized controlled trial . Clinical Trials.org # Abstract Purpose : To test the feasibility and acceptability of an implementation intention strategy ( if-then plans ) increasingly used in health psychology to bridge the goal intention – action gap in rehabilitation with people with neurological conditions who are experiencing difficulties with mobility . Methods : Twenty people with multiple sclerosis ( MS ) and stroke , r and omised to an experimental and control group , set up to three mobility related goals with a physiotherapist . The experimental group also formulated if-then plans for every goal . Data collection : Focus groups and interviews with participants and therapists ; Patient Activation Measure ( PAM ) , 10-m walk test , Rivermead Mobility Index , self-efficacy , subjective health status , quality of life . Results : Qualitative data highlighted one main theme : Rehabilitation in context , encapsulating the usefulness of the if-then strategy in thinking about the patient in the context of complexity , the usefulness of home-based rehabilitation , and the perceived need for a few more sessions . Changes in walking speed were in the expected direction for both groups ; PAM scores improved over 3 months in both groups . Conclusion : If-then plans were feasible and acceptable in bridging the goal intention – action gap in rehabilitation with people with MS and stroke , who are experiencing difficulties with mobility . This approach can now be adapted and trialled further in a definitive study . Implication s for Rehabilitation Goal planning in rehabilitation necessitates specific strategies that help people engage in goal -related tasks . If-then plans aim to support people to deal more effectively with self-regulatory problems that might undermine goal striving and have been found to be effective in health promotion and health behaviour change . This feasibility study with people with a stroke and multiple sclerosis has demonstrated that if-then plans are feasible and acceptable to patients and physiotherapists in supporting goal -directed behaviour OBJECTIVE To investigate the feasibility and preliminary outcomes of a home progressive resistance training ( PRT ) program augmented by neuromuscular electrical stimulation ( NMES ) . DESIGN R and omized controlled pilot trial . SETTING Participant homes . PARTICIPANTS People with multiple sclerosis ( MS ) ( N=37 ) who use a walking aid . INTERVENTIONS A 12-week home PRT program or the same program augmented by NMES . MAIN OUTCOME MEASURES Strength using h and -held dynamometry ; repeated sit to st and test ; Berg Balance Scale ; timed Up & Go test ; 12-Item Multiple Sclerosis Walking Scale ; Multiple Sclerosis Impact Scale-29 , version 2 ; and Modified Fatigue Impact Scale ( MFIS ) . The NMES group also completed a device usability question naire . RESULTS Only change in MFIS score was significantly greater in the NMES group than the PRT group ( P=.012 ) . The NMES group improved significantly in quadriceps endurance ( median of change , 8.5 ; P=.043 ) , balance ( median of change , 3.5 ; P=.001 ) , physical impact of MS ( median of change , -8.3 ; P=.001 ) , and impact of fatigue ( median of change , -17 ; P=.001 ) . Participants rated the device as highly usable . CONCLUSIONS This pilot study suggests that a home PRT program with NMES is feasible , and the neuromuscular electrical stimulation device is usable by this population . Only reduction in impact of fatigue was greater in the NMES than the PRT group Background : The most effective exercise dose has yet to be established for multiple sclerosis ( MS ) . Objective : The aim of this study was to investigate the effect of different exercise intensities in people with MS . Methods : We completed a r and omized comparator study of three cycling exercise intensities , with blinded assessment , was carried out in Oxford . Sixty-one adults with MS who fulfilled inclusion criteria were r and omized at entry into the study , using a computer-generated list held by an exercise professional  , into either : continuous ( at 45 % peak power , n = 20 ) , intermittent ( 30 sec on , 30 sec off at 90 % peak power , n = 21 ) or combined ( 10 min intermittent at 90 % peak power then 10 min continuous at 45 % peak power , n = 20 ) exercise for 20 min twice a week for 12 weeks in a leisure facility . Groups were assessed at : baseline , halfway ( 6 weeks ) , end intervention ( 12 weeks ) and follow-up ( 24 weeks ) . Primary outcome measure was 2 min walk . Results : Fifty-five participants were included in the analysis ( n = continuous 20 , intermittent 18 , combined 17 ) . No differences were found between groups . After 6 weeks , considering all participants , 2 min walk distance increased by 6.96 ± 2.56 m ( 95 % CI : 1.81 to 12.10 , effect size ( es ) : 0.25 , p < 0.01 ) . The continuous group increased by 4.71 ± 4.24 m ( 95 % CI : −3.80 to 13.22 , es : 0.06 ) , intermittent by 12.94 ± 4.71 m ( 95 % CI : 3.97 to 21.92 , es : 0.28 ) and combined by 3.22 ± 4.60 m ( 95 % CI : −6.01 to 12.46 , es : 0.04 ) . Two minute walk did not significantly change between further assessment s. Between 6 and 12 weeks there was a drop in attendance that seemed to be associated with the intermittent and combined groups ; these groups also had a greater number of adverse events ( leg pain during cycling most common ) and dropouts ( n = continuous 1 , intermittent 5 , combined 10 ) . Considering all participants , 6 weeks of cycling exercise  produced benefits in mobility that were maintained with further sessions . Conclusion : While no differences were found between groups , greater benefit may be associated with higher-intensity exercise , but this may be less well tolerated . CONSORT - trial registration number ( IS RCT N89009719 Background : Few high- quality trials have examined the effects of progressive resistance training ( PRT ) on people with multiple sclerosis ( MS ) . Objective : To determine the effectiveness of PRT for people with MS , focusing on improving the gait deficits common in this population . Methods : Using a single blind r and omized controlled trial , people with relapsing – remitting MS were r and omly allocated to either a PRT program targeting the lower limb muscles twice a week for 10 weeks ( n = 36 ) , or usual care plus an attention and social program conducted once a week for 10 weeks ( n = 35 ) . Outcomes were recorded at baseline , week 10 and week 22 . Results : Participants attended 92 % of training sessions , with no serious adverse events . At 10 weeks , no differences were detected in walking performance . However , compared with the comparison group PRT demonstrated increased leg press strength ( 16.8 % , SD 4.5 ) , increased reverse leg press strength ( 29.8 % , SD 12.7 ) , and increased muscle endurance of the reverse leg press ( 38.7 % , SD 32.8 ) . Improvements in favor of PRT were also found for physical fatigue ( Mean difference −3.9 units , 95%CI −6.6 to −1.3 ) , and the physical health domain of quality of life ( Mean difference 1.5 units , 95%CI 0.1 to 2.9 ) . At week 22 almost no between-group differences remained . Conclusion : PRT is a relatively safe intervention that can have short-term effects on reducing physical fatigue , increasing muscle endurance and can lead to small improvements in muscle strength and quality of life in people with relapsing – remitting MS . However , no improvements in walking performance were observed and benefits do not appear to persist if training is completely stopped Objective : Investigate the feasibility and potential efficacy of a customized print-based intervention to promote physical activity and symptom self-management in women with multiple sclerosis . Design : A r and omly allocated two-group repeated measures design , with a delayed-treatment contact group serving as the control . Participants were r and omized to receive the intervention immediately ( n = 14 ) or receive it at week 12 ( n = 16 ) . Outcome measures were administered at weeks 1 , 12 , and 24 . Setting : Community-based in metropolitan area . Subjects : Thirty women with multiple sclerosis . Intervention : Prescribing a home-exercise program and following up with customized pamphlets , which are matched to participants ’ stage of readiness to change physical activity behavior and physical activity barriers ( e.g. encouraging self-management of symptoms ) . Main Measures : Physical Activity and Disability Survey-revised , Godin Leisure-Time Exercise Question naire , SF-12 , Symptoms of Multiple Sclerosis Scale , and 6-minute walk test . Results : Intent-to-treat analyses using mixed multivariate analysis of variance ( MANOVA ) were conducted on ( 1 ) physical activity levels and ( 2 ) health and function outcomes . The mixed MANOVAs for physical activity levels and health and function outcomes indicated significant improvements in the immediate group compared with the delayed group ( i.e. condition by time interaction was significant , Wilks ’ λ = 0.59 , F2 , 27 = 9.31 , P = 0.001 and Wilks ’ λ = 0.70 , F4 , 25 = 2.72 , P = 0.052 , respectively ) . The intervention had moderate to large effect sizes in improving physical activity levels ( d = 0.63 to 0.89 ) , perceptions of physical function ( d = 0.63 ) , and 6-minute walk test ( d=0.86 ) . Conclusion : This pilot study indicates that a customized print-based intervention shows promise in improving physical activity levels and health and function in women with multiple sclerosis This pilot study investigated whether 4 weeks of aerobic treadmill training in individuals with multiple sclerosis ( MS )  improved mobility and reduced fatigue .  Individuals with MS were recruited to this prospect i ve , r and omised controlled trial . Individuals were assessed at baseline , week 7 and 12 with a 10 metre timed walk , a 2 minute walk , the Rivermead Mobility Index , and the Fatigue Severity Scale . After a pre- assessment familiarisation session and a baseline assessment , individuals were r and omly allocated to an initial intervention or delayed intervention group . Treadmill training consisted of 4 weeks of supervised aerobic exercise delivered weeks 3–6 in the immediate group and 8–11 in the delayed group . Of the initial 19 recruits , 16 individuals completed the study . There was a significant difference in walking endurance between the delayed and immediate groups at baseline ( p<0.05 ) . On re assessment in week 7 , decreases in 10 metre walk time were found in both groups , which was significant in the immediate group ( p<0.05 ) . The 2 minute walk distance significantly increased in both groups ( p<0.05 ) . In the training group , reassessed at week 12 after training ceased , there was a return towards baseline scores . No significant changes in fatigue scores were found . This study showed that in individuals with MS  , aerobic treadmill training is feasible and well tolerated . Walking speed and endurance increased following training with no increase in reported fatigue . Detraining occurred in the period following training . A larger r and omised clinical trial is warranted People with multiple sclerosis ( MS ) are likely to benefit from regular exercise , but physical inactivity is more common among people with MS than among the general population . This small r and omized study evaluated whether motivational interviewing ( MI ) affects adherence to and personal experience in an exercise program .  Inactive people with MS participating in an eight-week exercise program  were r and omized to either three brief MI ( n = 7 ) or three health coaching ( n = 6 ) sessions . Session attendance for both conditions was high , and MI fidelity was rigorously and reliably measured using the Motivational Interviewing Treatment Integrity Scales . The feasibility of using this approach was demonstrated with a small sample . Large effects favoring the MI condition were found for physical exertion , affect during exercise , and fatigue , but no effects were found for adherence to the exercise program . Treatment integrity measures of MI  were correlated with outcomes in expected directions . Although this study demonstrated the feasibility of this MI approach , the large effect sizes found should be viewed with substantial skepticism and replicated in sufficiently powered studies using objective measures of exercise adherence There is increasing recognition that exercise is an efficacious strategy for managing many consequences of multiple sclerosis ( MS ) , yet persons with MS are not engaging in sufficient exercise for accruing health benefits . Poor exercise uptake might be associated with the design of previous research . We conducted a r and omised controlled trial ( RCT ) for examining the feasibility of a 4-month home-based , exercise-training program design ed based on recent physical activity guidelines for MS and supplemented by behavioural strategies for compliance . Feasibility was assessed in the domains of process ( e.g. , recruitment ) , re source ( e.g. , monetary costs ) , management ( e.g. , personnel time requirements ) and scientific outcomes ( e.g. , treatment effect ) . We recruited persons with mild-to-moderate MS who were r and omised into an intervention or wait-list control condition . Intervention participants received a pedometer , elastic resistance b and s , DVD , training manual , calendars , log-book , video coaching calls and newsletters . Participants in both conditions completed home-based assessment s before and after the 4-month period . Ninety-nine persons with MS were assessed for eligibility , and 57 were r and omised . Fifty-one persons completed the study ( 90 % ) . Total costs of the study were US $ 5331.03 . Personnel time to conduct the study totaled 263h . Participants in the intervention group complied fully with 71 % of all exercise sessions . There was a moderate increase in self-reported exercise behaviour of the intervention participants as measured by the Godin Leisure-Time Exercise Question naire ( d≥0.5 ) . The results support the feasibility and acceptability of a home-based exercise intervention based on physical activity guidelines and supplemented with behavioural strategies for adults with mild-to-moderate MS Abstract Purpose : This mixed methods study aim ed to explore the feasibility , efficacy and the participants ’ experiences of a Pilates programme for people with Multiple Sclerosis ( pwMS ) who use a wheelchair . Method : Fifteen pwMS took part in the 12-week Pilates programme . At baseline and after 6 and 12 weeks of the programme , sitting stability , measured as maximum progression of the Centre of Pressure when leaning sideways ( COPmax ) , posture , pain on a Visual Analogue Scale , function , fatigue and the impact of MS ( MSIS29 ) were assessed . Ten participants took part in two focus groups within six weeks of the completion of the programme . Results : Significant improvements at the 12-week assessment were found in COPmax ( p = 0.046 ) , sitting posture ( p = 0.004 ) , pain in the shoulders ( p = 0.005 ) and back ( p = 0.005 ) and MSIS29 ( p = 0.006 ) . The majority of participants described various physical , functional , psychological and social benefits from participation that reflected increased confidence in activities of daily living . Enjoyment of the classes was expressed by all , and most wished to continue participation . Conclusions : Pilates appears to be efficacious in improving sitting stability and posture and decreasing pain and was also well tolerated by wheelchair users with MS . Further mixed methods studies are warranted . Implication s for Rehabilitation Group-based core stability exercise or Pilates for people with MS who use wheelchair is a feasible and safe way of exercising for this patient group . Pilates exercises for people moderately to severely affected by MS result ed in a decrease in back and shoulder pain and improvement in sitting balance . Future appropriately powered r and omised controlled studies into Pilates for people with MS reliant on wheelchair are warranted
target: Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) .
  Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .
background: Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis ( MS ) .
  There is disagreement regarding the strength of this research , perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing .
  We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS .