Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study

Abstract

ObjectiveTo investigate feasibility of multiple sclerosis (MS) exercise guidelines for inactive people with MS (PwMS) and to examine preliminary efficacy for walking. To investigate effect of augmenting that intervention with education based on social cognitive theory (SCT).DesignPilot multicentre, double-blind, randomised, parallel, controlled trial.SettingCommunity-delivered programme.ParticipantsSixty-five physically inactive PwMS walked independently, scored 0–3 on the Patient Determined Disease Steps Scale, had no MS relapse or change in MS medication in 12 weeks.Interventions10-week exercise plus SCT education (SCT) compared with exercise plus attention control education (CON).Outcome measuresSix-Minute Walk Test (6MWT), Timed Up and Go (TUG) test and Multiple Sclerosis Walking Scale-12 (MSWS-12).Results174 expressed interest, 92 were eligible and 65 enrolled (SCT, n=32; CON, n=33). The intervention was feasible and delivered as intended. 68% of SCT group and 50% of control group met the exercise guidelines after intervention. Using linear mixed effects models, intention-to-treat basis, there was insufficient evidence for difference between the groups over the trial (6MWT, p=0.30; TUG, p=0.4; MSWS-12, p=0.8). Using secondary analysis of a cohort with data for≥3 assessments (SCT, n=21; CON, n=20), there was significant treatment effect favouring the intervention group (p=0.04) with mean effect for 6MWT 39.0 m (95% CI 2.26 to 75.73) at 12 weeks and 40.0 m (95% CI 2.3 to 77.8) at 36 weeks. Both groups improved significantly in 6MWT following 10-week intervention (SCT, mean ∆=83.02, SD=60.1, p≤0.01; CON, mean ∆=56.92, SD=73.5, p≤0.01), TUG (SCT, ∆=−0.70, SD=1.25, p≤0.01; CON, ∆=−0.54, SD=0.95, p≤0.01) and MSWS-12 (SCT, ∆=−8.03, SD=16.18, p=0.02; CON, ∆=−0.86, SD=18.74, p=0.81).ConclusionsA 10-week exercise programme based on the MS exercise guidelines for improving walking in previously inactive PwMS was feasible. There is marginal evidence of a treatment effect in favour of the exercise plus SCT intervention at 12 and 36 weeks.Trial registration numberNCT02301442; Results.

Safety, feasibility, acceptability and effects of a behaviour-change intervention to change physical activity behaviour among people with multiple sclerosis: Results from the iStep-MS randomised controlled trial

“…Seven of the 14 studies did not mention adverse events (AEs), 14,[17][18][19] five stated no AEs were recorded without providing information on how this was assessed, 1,16,20 one assessed AEs in the intervention group only, 15 and one reported related-AEs only. 13 We therefore aimed to examine the safety, feasibility, acceptability and effects of a behaviour-change intervention to increase PA and reduce sedentary behaviour among people with MS, and to explore the feasibility of conducting a larger trial to evaluate effectiveness.…”

“…This is an important step in evaluating a complex intervention that can enable differentiation between true ineffectiveness and implementation failure, 12 and has not been well described in this context to date. Of the 14 studies included in the meta-analysis of behaviour-change interventions, 6 one reported fidelity to content 13 and another reported fidelity to delivery. 14 No study explored the feasibility of delivering behaviour-change interventions to change PA behaviour from the perspective of the intervention provider.…”

Beyond current research practice: Methodological considerations in MS rehabilitation research (is designing the perfect rehabilitation trial the Holy Grail or a Gordian knot?)

“…Given the complex nature of most rehabilitation interventions, in the context of a trial, it is vital for reliability and validity of the findings that the intervention is delivered as intended , consistently across participants and sites, and any deviations from the planned intervention recorded. While some MS trials describe intervention fidelity, 38,39 this is not yet the norm, despite guidelines available on treatment fidelity in health behaviour change studies, 40 which can be adapted for MS rehabilitation trials. This said, assessing fidelity in complex interventions is challenging, because it not only requires an examination of what was delivered (content), but also how the intervention was delivered (process).…”

The effectiveness of interventions targeting physical activity and/or sedentary behaviour in people with Multiple Sclerosis: a systematic review

“…A total of 1697 participants were included in the review with study samples ranging from 14 to 218 participants. Studies evaluated interventions based upon exercise prescription (n=5) [28][29][30][31][32]; behaviour change interventions (n=10) [33][34][35][36][37][38][39][40][41][42][43][44][45][46]; exercise prescription and behaviour change interventions (n=7) [47][48][49][50][51][52][53][54]; and health promotion education (n=3) [55][56][57] (Table 2).…”

“…The majority of studies (n=14) lasting 8-12 weeks [28,30,31,34,35,[41][42][43][44][48][49][50][51][52]55,57]; with other interventions lasting four [47], five [56] and six months [29,[37][38][39][40]46,54]. Thirteen studies did not follow-up participants after the intervention period, while 12 studies included a follow-up assessment of participants at 1 month [33]; 3 and 6 months [34,57], 6 months only [30,[41][42][43]49,50], 8 months [56], 6 and 9 months [52,53], 9 months only [48] and 12 months [54].…”