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Contemporary Clinical Trials
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Pragmatic exercise intervention in people with mild tomoderate multiple sclerosis: A randomised controlledfeasibility study
Anouska M. Carter a,⁎, Amanda J. Daley b, Sue W. Kesterton a, Nicola M. Woodroofe c,John M. Saxton d, Basil Sharrack e,f
a Centre for Sport and Exercise Science, Faculty of Health and Well-being, Sheffield Hallam University, Collegiate Crescent, Sheffield S10 2BP, UK 1
b Department of Primary Care Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UKc Biomedical Research Centre, Faculty of Health and Well-being, Sheffield Hallam University, Collegiate Crescent, Sheffield S10 2BP, UKd School of Allied Health Professions, University of East Anglia, Norwich NR4 7TJ, UKe Neurology Department, Sheffield Teaching Hospitals, Royal Hallamshire Hospital, Glossop Road, Sheffield S11 7FE, UKf Sheffield Institute of Translational Neuroscience, The University of Sheffield, UK.
a r t i c l e i n f o
Abbreviations: PwMS, People with Multiple SclerosNHS, National Health Service; EDSS, Expanded DisabiRate of Perceived Exertion; TRIMP, Training impulseGNDS, Guy's Neurological Disability Scale; BMI, BodMultiple Sclerosis Functional Composite; MSQOL-5Quality of Life-54; HRQOL, Health Related Quality ofMaximisation⁎ Corresponding author. Tel.: +44 114 2255633,+44
Article history:Received 30 November 2012Received in revised form 10 April 2013Accepted 12 April 2013Available online 21 April 2013
Background: People with Multiple Sclerosis (PwMS) are less physically active than the generalpopulation and pragmatic approaches designed to equip them with the skills and confidenceto participate in long-term physical activity are required.Objective: The objective of this study was to determine the feasibility of a pragmatic exerciseintervention 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 fromeligible participants attending outpatient clinics. A total of 28 participants were randomised to a10 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 atbaseline, immediately and 3 months after the intervention.Results: Attrition was low (2 participants lost to immediate follow-up and 4 participants lost to3 month follow-up), with high compliance rates (>75% of all sessions). The intervention groupachieved 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 = trainingimpulse/load [arbitrary units; AU]) (2600 ± 1105 to 3210 ± 1269 AU) during the intervention,whilst significantly increasing(P = 0.050) their physical composite score (MSQOL-54) at10 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 toassess its long-term impact on physical activity behaviour.
is; QoL, Quality of life;lity Status Score; RPE,; AU, Arbitrary units;y Mass Index; MSFC,4, Multiple SclerosisLife; EM, Expectation
1709 816867 (home);
ll rights reserved.
1. Introduction
Evidence suggests that People with Multiple Sclerosis(PwMS) are less physically active than the general population[1], but exercise self-efficacy has consistently been reported toinfluence participation [2,3]. Current research supports thehealth benefits of supervised, one to one facility based exerciseinterventions for people with mild to moderate disabilityfrom Multiple Sclerosis (MS). These include, increased muscle
41A.M. Carter et al. / Contemporary Clinical Trials 35 (2013) 40–47
strength and aerobic capacity, improved mood state and en-hanced quality of life (QoL), with no evidence of patient harm[4,5]. In the long-term, this approach may prove difficult forPwMS and is unlikely to be cost effective. More high qualityrandomised control trials (RCTs) to assess the efficacy of prag-matic interventions for equipping PwMS with the skills andconfidence needed to exercise independently long-term arerequired [6]. This is important as despite the benefits of exer-cise, PwMS appear to find long-termexercise behaviour changedifficult and interventions based on behaviour change theo-ries are likely to optimise the chances of long term behaviourchange. One approach to this is the Transtheoretical Model [7]of behaviour change, which outlines a series of stages thatpeople move through in the behaviour change process andsuggests strategies or processes that can be used to facilitatemovement through the stages. This model has been used topromote physical activity behaviour change in other popula-tions but not in PwMS [8].
The primary aim of this study was to investigate thefeasibility of a ‘pragmatic’ exercise intervention, that includ-ed cognitive–behavioural strategies within the framework ofthe Transtheoretical Model, to facilitate long term physicalactivity behaviour change in PwMS. In this study ‘pragmatic’is defined as a practical, achievable and flexible programmethat allows for individual choice and utilises behaviourchange tools to enhance self-efficacy and promote long-termbehaviour change. Feasibility was measured in terms of re-cruitment, acceptability of the intervention, compliance andattrition, safety and suitability of exercise dose and appropri-ateness of outcomemeasures. The secondary aimwas to obtainpreliminary data on the impact of the intervention on keyhealth outcomes by comparison with PwMS randomised toa usual care control group. We hypothesized that PwMS willfind a pragmatic approach to exercise feasible, with resultsindicating improvements in physical function and quality oflife.
2. Methods
2.1. Participant inclusion/exclusion criteria
A total of 30 participants were recruited fromMS clinics atSheffield Teaching Hospitals NHS Foundation Trust (UK). Allparticipants were aged 18–65 years, fulfilled the modifiedMcDonald diagnostic criteria for MS [9], had an ExpandedDisability Status Score (EDSS; [10]) ≤5.5 and were stable ondisease modifying treatment for ≥3 months prior to recruit-ment. Participants who experienced relapses within thepreceding 3 months, had other illnesses substantially affectingtheir ability to exercise (confirmed by consultant physician) orwho were physically active (≥2× per week, ≥30 min persession, during the previous 3 months) were excluded. Ethicsand research governance approval for this studywere obtainedthrough Sheffield Research Ethics Committee and the SheffieldTeaching Hospitals NHS Foundation Trust, respectively.
2.2. Study design
This feasibility study was a parallel randomised controlledtrial (RCT). Following completion of baseline assessments, 28participants were randomly assigned to either pragmatic
exercise or usual care control groups. The randomization listwas computer generated by an independent researcher andwas concealed from those conducting assessments. Bothgroups had access to usual medical care.
2.3. Pragmatic exercise therapy intervention
Participants attended two supervised sessions and under-took one home session per week for 10 weeks. Supervisedsessions were delivered one-to-one and led by an exerciseresearcher, qualified up to postgraduate level in sport andexercise science, with applied accreditation in exercise deliv-ery. The project lead observed the delivery of the interventionat the start to ensure that protocols were interpreted correctlyand consistently. Each session lasted approximately 1 h, withparticipants being offered a range of aerobic exercise options(rowing, walking, upright cycle, recumbent bike and cross-trainer), delivered as short bouts (e.g. 5× for 3 min,with 2 minrest) at 50 to 69% age predictedmaximumheart rate (ratings ofperceived exertion [RPE] 11 to 13 on the Borg RPE Scale).Training impulse (TRIMP), calculated as average exercise heartrate (beats/min) × duration (min), and expressed in arbitraryunits (AU), was used to quantify overall exercise training load[11]. TRIMP is a method used to quantify aerobic exercise train-ing load and is useful for expressing the total “dose” of exerciseachieved during an intervention and rate of progression.
The exercise programme was progressive and tailoredtowards individual capabilities and preferences. Participantswere encouraged to try all appropriate exercise options, butwere given a choice over the exact modality, duration andintensity of the sessions. Sessions were then designed andprogressed on the basis of individual preferences. Each sessioncontained awarm-up, followed by an aerobic component, tailor-ed functional body conditioning exercises based on indivi-dual need (balance, strength and flexibility) and a cool down,with content recorded (exercise modality, heart rate, RPE andduration). Body conditioning exercises included supported bodyresistance exercises (e.g. squats against the wall), gym ballexercises for core stability and static stretching for large musclegroups. This type of tailored approach is recommended forPwMS [6]. Using the Transtheoretical Model [7] as a guidingframework, a variety of cognitive behavioural techniques (e.g.consciousness raising, goal setting and finding social support forexercise) were also used during sessions to promote motivationand confidence for exercise. Exercise researchers were trained inthe delivery of the intervention and detailed guidelines onweekly contentwere provided. The behavioural techniqueswereintegrated into the exercise sessions and the instructor usedstrategies appropriate to the conversation, the stage of changeparticipants were at, and difficulties/questions participantsraised during sessions. Full details of the behaviour changestrategy have been published previously [12].
Home session content comprised both aerobic exercise andbody conditioning activities, and was agreed with the partic-ipant after taking into account their needs, preferences, goalsand exercise opportunities in their community. The durationand intensity of the home exercise sessions mirrored the leveland progression achieved in the supervised sessions. Homesessions were included to promote independent exerciseparticipation following the intervention. Participants complet-ed a physical activity diary to log compliance and diaries were
42 A.M. Carter et al. / Contemporary Clinical Trials 35 (2013) 40–47
checked and confirmed weekly, with participants being madeaware of the importance of recording accurate data.
2.4. Usual care control group
The usual care group continued with their usual NationalHealth Service Care (NHS) and were offered the opportunityto receive advice and take part in three supervised sessionsonce they had completed the study.
2.5. Assessment of outcomes
All participants were assessed at baseline, immediatelyfollowing the intervention (week 10) and 3 months post inter-vention. Participants were initially assessed on the hospital siteby a neurologist (BS) who assigned EDSS [10] and Guy's Neu-rological Disability Scale (GNDS, [13]) scores. All other assess-ments were undertaken at Sheffield Hallam University.
Height (m) and body mass (kg) for Body Mass Index (BMI)and waist and hip circumferences (cm) were measured usingstandard techniques [14]. Aerobic capacity was determinedusing a continuous, resistance incremented, sub-maximal cycleergometer test. The test was terminated when participantsreached a rating of perceived exertion of 17 (very hard), withtime to termination recorded [15]. The 25 ft walk from theMultiple Sclerosis Functional Composite (MSFC) assessmentwas included as a measure of clinical functional ability [16].QoLwas assessed using theMultiple Sclerosis Quality of Life-54(MSQOL-54 [17]), which includes a generic health related QoLinstrument (Rand 36-item health survey 1.0 [18]) and 18additional items relevant to PwMS. Current physical activityand readiness to exercisewere assessed using the Godin Leisure-Time Exercise Questionnaire [19], which is a valid measure ofphysical activity in PwMS [20], and a visual-analogue stage ofchange ladder [21], with anchored labels for the five items fromthe standard stages of change for exercise questionnaire [22].Additionally, participants assigned to the exercise arm complet-ed a series of open–ended questions focusing on their reasons fortaking part, confidence, side effects, barriers and attitudestowards exercise following the intervention.
Table 1Baseline characteristics of pragmatic exercise and usual care groups.
Data were analysed using SPSS for Windows version 18.0(SPSS Inc., Chicago, Illinois, USA). Statistical significancewas setat P b 0.05. Data were first checked for normality usingKolmogorov–Smirnov test and found to be normally distribut-ed. Data analysis was conducted using the intention to treatprinciple, with missing data points checked to be random(Little's Chi Squared test), and then imputed using the SPSSExpectation Maximisation (EM) method. Data were analysedusing analysis of covariance (ANCOVA), with baseline valuesused as the covariate, to compare differences between groupsat each time point (Follow-up 1/week 10 and Follow-up2/3 months) [23]. Results are presented as mean (±SD) ateach time point. As this was a feasibility study, changes inoutcome data are considered to be preliminary, and a cautiousapproach to interpretation has been taken.
3. Results
3.1. Recruitment, retention and compliance
Thirty PwMSwere recruited at a rate of 1.4 participants permonth, of these 28 were randomised to pragmatic exercise(n = 15) or usual care control (n = 13). Two participantswithdrew prior to randomization (increased commitments,opted to participate in drugs trial). Table 1 shows the baselinecharacteristics of participants.
From the usual care group, one participant withdrew inweek 10 (MS relapse), whilst in the intervention group, oneparticipant withdrew in week 5 due to increased work andfatigue. Attrition was low, with 93% completing the week 10assessments. A further two participants from the interventiongroup were lost to follow-up at 3 months, when they failed torespond to study visit invitations (86% completion; Fig. 1). Noadverse events resulting from the intervention were reported.Compliance was high, with participants attending 76% ofsupervised exercise sessions (15.2 ± 2.7) and an average of75% of prescribed home sessions (7.5 ± 2.2).
3.2. Exercise dose and preference
The mean duration of the aerobic component of supervisedsessions progressed from 24.3 ± 7.0 to 30.9 ± 5.5 min acrossthe 10 weeks, with 11 participants showing an increase. Thiswas accompanied by an increase in intensity (meanpercentageof age predicted [HRmax]), with participants progressing from60.4 ± 8.8 to 67.7 ± 6.9% HR max. Overall TRIMP showedsteady progress from 2600 ± 1105 to 3210 ± 1269 AU. Theincreased in TRIMP was achieved with only small changes inRPE, 11.2 ± 0.8 to 11.6 ± 0.8, excluding the first session (RPE10.8 ± 0.8), which was intentionally light to assess individualresponses to exercise (Fig. 2).
During supervised exercise, themost usedmode of exercisewas the treadmill, with a mean duration of 14.0 ± 5.5 min persession (Fig. 3). The most popular activity for home sessionswas walking (68%), although participants also used publicgyms and swimming pools (14%), engaged in activities of dailyliving (gardening and housework) (10%) and used exerciseequipment at home (8%).
3.3. Functional, clinical and anthropometric outcomes
Therewas encouraging evidence of improvements inwalkingspeed between baseline and 3 months and EDSS betweenbaseline and 10 weeks in the intervention group comparedwith usual care, but with changes being of border-line statistical
Identified at MS clinic by consultant as eligible and
interested (n=30)
En
rolm
ent
Allo
cati
on
Fo
llow
-up
1A
nal
ysis
Fo
llow
-up
2A
nal
ysis
Withdrew (n=2)• Opted to start drug trial (n=1)• Time commitments changed (n=1)
Randomized (n=28)
Allocated to usual Care (n=13) Allocated to pragmatic exerciseintervention (n=15)
Discontinued Intervention • In hospital with relapse (week10) (n=1)
Discontinued Intervention• Work commitment and fatigue (week5) (n=1)
Analysed follow-up 1 (week10)(n=12)
Analysed follow-up 2 (week 24) (n=12)
Analysed follow-up1 (week10)(n=14)
Lost to follow-up• Could not contact (n=2)
Analysed follow-up 2 (week24)(n=12)
Fig. 1. CONSORT diagram of patient recruitment and retention during the study.
43A.M. Carter et al. / Contemporary Clinical Trials 35 (2013) 40–47
significance (P = 0.08 and 0.07 respectively) (Table 2). Therewere no improvements in other MSFC variables or in anthro-pometric variables over the duration of the trial.
3.4. Physical activity outcomes and quality of life
The exercise group increased their readiness to exercise(P = 0.003), based on the visual analogue stages of changeladder [19] (Fig. 4) and there was a trend for an increase inmoderate intensity physical activity (P = 0.08), based onresults from the Godin Leisure-Time Exercise Questionnaire
[19] (Table 3) at 3 months. In addition, this group also scoredhigher on the physical health composite component (P = 0.05)of the MSQOL-54 [16] at 10 weeks (Table 3).
3.5. Qualitative analysis
Data are reported as frequency counts for each of thequestions asked. Over 90% of participants felt confident theywould continue to exercise. When asked about feelings duringand after exercise, 100% (n = 14) gave positive comments,with remarks such as ‘exercise made them feel more awake’,
Fig. 2. Change in exercise load over a pragmatic 10-week supervised programme, with error bars reflecting SD (n = 15).
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‘eased aches and pains’, and that they ‘only occasionally felttired’. Following exercise, 36% (n = 5) reported feeling moreenergetic, 29% (n = 4) reported that they felt tired at first butthis improved and 29% (n = 4) continued to feel occasionaltiredness, but this was reported as manageable. All participantsliked the session structure as it was tailored, built up gradually,manageable and they liked having goals and targets. However,14% (n = 2) did suggest a wider variety of equipment wouldhave been preferable.
Fig. 3. Exercise preference during supervised exercise
4. Discussion
This study evaluated the feasibility of a mixed (supervisedand home-based) pragmatic exercise intervention, designed topromote confidence and motivation for self-directed exercisein people with mild to moderate disability due to MS. Ourfindings suggest that this type of intervention is feasible, withexcellent retention (10 weeks, 87%; 3 months, 80%) and highcompliance (>75% of all sessions) rates, and with this
Table 2Physiological, functional and anthropometric outcomes at baseline, follow-up 1 (week-10) and follow-up 2 (week-24) in the pragmatic exercise and usual caregroups.
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pragmatic approach leading to progression in exercise durationand intensity over the 10 week intervention period. Ourpreliminary data also suggests that PwMS might experienceimportant behavioural and QoL benefits that are retained for atleast 3 months. However, caution should be heeded wheninterpreting outcome data from feasibility studies, as partici-pant numbers are not powered for statistical significance.
4.1. Recruitment, retention and compliance
Our study recruitment rate (1.4 PwMS/month) was compa-rable to a cognitive behavioural trial that recruited via clinics inSheffield [24]. Recruitment to future large scale interventionscould be enhanced byusing a range of differentmethods to reacheligible patients (mail-outs, advertisements, patient notes and amulti-centre approach). The implementation of an efficient andeffective recruitment strategy for patients on clinical trials iscritical to avoid expensive delays and failures [25].
Fig. 4. Change in exercise stage of change from baseline to follow-up 1 andbaseline to follow-up 2 in the pragmatic exercise and usual care groups. *indicates significant change from baseline.
Trial retention was excellent (93% at 10 weeks; 86% at3 months). Previous supervised interventions using a similarexercise frequency and intensity have reported slightly lowerretention rates (73 to 85% at follow-up 1) [26–29]. The inclusionin our study of home exercise, individually tailored sessions anda framework to promote motivation and confidence to exercisemay have increased retention rates. Previous home-basedinterventions that have focused on resistance or physiotherapyexercises, have reported excellent retention rates of 95% to 100%[30,31]. However, to our knowledge, McCullagh et al. [32] is theonly other exercise intervention study to report long-termfollow-up data for PwMS (83% retention at follow-ups 1 and 2),which is comparable to the rates reported here.
Compliance to exercise was also excellent, with 80% ofparticipants completing at least 70% of both supervised andhome sessions and with no adverse events being reported.Petajan et al. [26] reported 97% compliance to a moderateintensity aerobic exercise programme (3× perweek; 15 weeks),whilstMostert andKesselring [33] reportedonly 65% compliance(5× per week; 4 weeks) during exercise at the individuallydetermined anaerobic threshold. Home-based exercise compli-ance rates are also variable, with a physiotherapy-led resistanceprogramme (3× per week; 8 weeks) reporting 95% compliance[30]. However, a combined supervised and home-based aerobicprogramme, reported 83% compliance for supervised exercise,with no participants achieving more than half of home-basedsessions [32]. This is much lower than our home sessioncompliance rates. However, their study [32] did not contain anycognitive–behavioural strategies to enhance self-efficacy andpromote positive behaviour change. This suggests that thestrategies used in the current study could have had a positiveimpact on home exercise adherence, with 90% feeling confidentto continue exercise after the programme. This is supportedby previous research linking the importance of increased self-efficacy for physical activity participation in PwMS [34–36].Future exercise interventions should consider the importance ofthis component when designing trials for PwMS.
Table 3Exercise and quality of life outcomes at baseline, follow-up 1 (week-10) and follow-up 2 (week-24) in the pragmatic exercise and usual care groups.
MSQOL-54: Multiple Sclerosis Quality of Life-54; BL: Baseline; FU1: follow-up 1, week-10; FU2:follow-up 2, week-24, 3-month post intervention.* indicates significant difference from baseline.
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4.2. Exercise progression and preferences
This study aimed to progress exercise sessions by increasingintensity and duration whilst keeping RPE between 11 and 13(fairly light to somewhat hard). Exercise dose, intensity andTRIMP all increased across the programme, whilst RPE remainedrelatively constant, suggesting progression was well tolerated.Motl et al. [37] reported a relatively fast exercise progression ratein PwMS (EDSS 4.0–6.0), from 15 to 60 min per session duringan 8 week, moderate intensity, supervised programme. Rassovaet al. [38] reported progression from 2–10 min of cyclingexercise during week 1 (60% VO2 max), to 10–30 min at week10. This progression rate is similar to results from our study,where progression was participant led.
During the intervention PwMS were encouraged to try allsuitable ergometers and provide feedback on preferences, toinform future programme design. During supervised exercise,the treadmill was utilised the most. Rowing and cyclingergometers were also used frequently, but were not as welltolerated for long durations, either due to the higher intensityof the activity (rower) or localized muscle fatigue (cycle). Thisconflicts with suggestions that rowing was only likely to betolerated by well-functioning patients [5], as after initialtraining on correct usage all our participants included rowingin their programme. Previous exercise research with PwMShas focused on treadmill or cycle ergometry [6] and to ourknowledge no other intervention has incorporated rowingexercise. Anecdotally, for participants experiencing musclefatigue, alternating between equipment using different musclegroups enabled participants to undertake more continuousexercise. At home, 68% of total exercise time was spentwalking, in accordance with previous research [38].
4.3. Outcome measures
The high retention rates in both groups suggest that despitethe large number of outcomemeasures, the volume and type ofassessmentswere feasible and did not discourage participation.We observed significant improvements in stages of changeand QoL (Physical Health Composite score). There was alsoencouraging evidence of an improvement in 25 ft walk time,EDSS and increases in self-reportedmoderate intensity activity(of borderline statistical significance). In addition, participantsreported that they felt confident in continuing to be active and
enjoyed exercise. Despite these improvements, changes in thehealth outcomes should be interpreted with caution due to thesmall sample size. Anecdotally, participants commented onhaving the energy to do more at home, and using walking aidsless.
This encouraging preliminary evidence suggests that im-portant clinical, physical and QoL benefits may be achievablefrom this pragmatic approach to implementing exercisetherapy in PwMS, with some improvements present after afurther 3 months of follow-up. These results are consistentwith systematic review evidence, which concluded thatmild tomoderate exercise can be beneficial for PwMS without anynegative effects [4,6]. Pilot work by McCullagh et al. [32] sup-ports the sustained effects of exercise up to 3 months after theintervention, in terms of improvements in fatigue and QoL.However, a larger scale trial with longer-term follow-up needsto be conducted before conclusions regarding exercise main-tenance and long-term benefits can be drawn.
4.4. Study limitations
The eligible and interested participants that volunteered forthe study may not be representative of the broader MSpopulation, which could have implications for the generaliz-ability of the results. Furthermore, as changes in physicalactivity and home exercise were assessed by questionnaire,subjective fitness assessment and self-report activity diaries,this may have impacted on the results via social desirabilityresponses. The inclusion of an objective physical activitymeasure such as 7-day accelerometry would enhance futuretrials. The current study utilised strategies to enhance self-efficacy and confidence. However, it is recommended thatthese behaviour change constructs are explored in more detailin future trials to gain more insight into their impact onlong-term-behaviour change in PwMS. This study used TRIMPas a non-intrusive method of monitoring changes in exerciseload. This method does not take into account the limitations ofusing absolute heart rate as a measure of exercise intensity,particularly given the cardiovascular dysfunction reported inPwMS [39]. However, as TRIMP results compared the sameindividual over time, it is unlikely to have significantlyimpacted on the findings. Future studies would benefit fromusing more precise measurements of change in exercisetraining load. In addition, there is a need to monitor treatment
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fidelity during complex interventions and to understand thepotential for pragmatic exercise interventions to induce clini-callymeaningful changes in important health outcomes, such asfatigue, balance and neurological function in PwMS. Futurestudies would benefit from monitoring the other services suchas physiotherapy that were accessed by PwMS during the trial,as this may have impacted on outcome measures. It isrecommended that this is not only monitored in future trials,but also that this pragmatic tailored approach could be furtherenhanced if both the expertise of a physiotherapist and anexercise researcher were used in the programme design.
5. Conclusions
Our findings suggest that this type of pragmatic exerciseintervention is feasible for people with mild to moderate MS,with good compliance reported for both aspects of theprogramme. No other studies to date have investigated thefeasibility of this type of pragmatic exercise programme,combining individually tailored aerobic (supervised and home-based) exercise, with flexibility, balance and core work, andbehavioural strategies to encourage PwMS to bemore physicallyactive. In addition, a cautious consideration of the outcome datasuggests that PwMS can experience behavioural and QoLbenefits from participation and that these changes may besustained for up to 3 months after the intervention. Futurelarger-scale definitive trials, with longer follow-up are requiredto corroborate the results from this preliminary study.
Acknowledgements
This project was funded by Sheffield Teaching HospitalsNHS Foundation Trust and a larger scale randomised controlledtrial has been funded by the UK Multiple Sclerosis Society.
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