Fortune J1, Norris M1, Stennett A1, Kilbride C1, Anokye N1, Victor C1, Hendrie W2, deSouza L1, Lavelle G1, Ryan J1,3
1Brunel University London, London, United Kingdom, 2MS Therapy Centre, Norwich, United Kingdom, 3RCSI Royal College of Surgeons, Dublin, Ireland
Background: Although physical activity may reduce disease burden, fatigue and disability among people with multiple sclerosis (MS), many people with MS are physically inactive and spend increased time in sedentary behaviour. Behaviour-change interventions, which incorporate techniques such as goal setting, action planning, and self-monitoring, may be used to change physical activity behaviour among people with MS.
Purpose: The iStep-MS trial aimed to determine the safety, feasibility and acceptability of a behaviour-change intervention to increase physical activity and reduce sedentary behaviour among people with MS.
Methods: Adults with MS, who were independently ambulatory with or without a walking aid were recruited and randomised in a 1:1 ratio to a 12-week intervention or usual care. The intervention consisted of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Safety was determined by assessing pain (EQ-5D-5L pain question) and fatigue (MFIS) at baseline, 3 months and 9 months, and recording the incidence of falls, relapses, and other adverse events from baseline to 9 months. Feasibility and acceptability of the intervention was assessed by evaluating fidelity to the programme, and exploring the experience of the intervention through interviews with 15 participants and a focus group with 4 physiotherapists. Differences in pain and fatigue between groups at 3 and 9 months, respectively, adjusted for baseline values were investigated using ANCOVAs. Differences in the number of people experiencing an adverse event between groups was examined using logistic regression. Qualitative data was analysed using the Framework method.
Results: Sixty participants (mean age 56.8 [9.1] yr; 41 females; 16 EDSS 1-4.5) were randomised. Data were available on 55 participants at 3 months (iStep-MS=28; control=27) and 52 participants at 9 months (iStep-MS=27; control=25). Twenty-eight participants completed all four intervention sessions. One participant attended 3 sessions and one participant attended one session only. Fidelity to intervention delivery and engagement was good (>70%). Physiotherapists reported that intervention delivery was feasible. There was no difference in fatigue (p=0.104) or pain (p=0.290) between groups at 3 months or in pain at 9 months (p=0.066). Fatigue was lower in the intervention group at 9 months (β=-7.66, 95% CI -14.00 to -1.32, p=0.019). At 9 months, there was no difference between groups in the number of people experiencing a fall, relapse, or other adverse event. Participants reported that the study protocol (e.g. burden of assessment, study information provided, and venue) and intervention were acceptable and highlighted a number of positive subjective changes in their activity levels and confidence to complete physical tasks. Face-to-face empathic support from professionals who were specialists in MS, individualised goal setting and measurable monitoring and outcomes were identified as key components of the intervention. The acceptability of the pedometer was poor requiring exploration of alternative measurement options.
Conclusion(s): This feasibility study demonstrated that a behaviour-change intervention focused on changing physical activity behaviour in people with MS is safe, feasible and acceptable.
Implications: A physiotherapist-led intervention consisting of four sessions that incorporate behaviour-change techniques has the potential to change physical activity behaviour in people with MS. A definitive trial of the intervention is warranted.
Keywords: physical activity, physiotherapy, multiple sclerosis
Funding acknowledgements: MS Society UK
Purpose: The iStep-MS trial aimed to determine the safety, feasibility and acceptability of a behaviour-change intervention to increase physical activity and reduce sedentary behaviour among people with MS.
Methods: Adults with MS, who were independently ambulatory with or without a walking aid were recruited and randomised in a 1:1 ratio to a 12-week intervention or usual care. The intervention consisted of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Safety was determined by assessing pain (EQ-5D-5L pain question) and fatigue (MFIS) at baseline, 3 months and 9 months, and recording the incidence of falls, relapses, and other adverse events from baseline to 9 months. Feasibility and acceptability of the intervention was assessed by evaluating fidelity to the programme, and exploring the experience of the intervention through interviews with 15 participants and a focus group with 4 physiotherapists. Differences in pain and fatigue between groups at 3 and 9 months, respectively, adjusted for baseline values were investigated using ANCOVAs. Differences in the number of people experiencing an adverse event between groups was examined using logistic regression. Qualitative data was analysed using the Framework method.
Results: Sixty participants (mean age 56.8 [9.1] yr; 41 females; 16 EDSS 1-4.5) were randomised. Data were available on 55 participants at 3 months (iStep-MS=28; control=27) and 52 participants at 9 months (iStep-MS=27; control=25). Twenty-eight participants completed all four intervention sessions. One participant attended 3 sessions and one participant attended one session only. Fidelity to intervention delivery and engagement was good (>70%). Physiotherapists reported that intervention delivery was feasible. There was no difference in fatigue (p=0.104) or pain (p=0.290) between groups at 3 months or in pain at 9 months (p=0.066). Fatigue was lower in the intervention group at 9 months (β=-7.66, 95% CI -14.00 to -1.32, p=0.019). At 9 months, there was no difference between groups in the number of people experiencing a fall, relapse, or other adverse event. Participants reported that the study protocol (e.g. burden of assessment, study information provided, and venue) and intervention were acceptable and highlighted a number of positive subjective changes in their activity levels and confidence to complete physical tasks. Face-to-face empathic support from professionals who were specialists in MS, individualised goal setting and measurable monitoring and outcomes were identified as key components of the intervention. The acceptability of the pedometer was poor requiring exploration of alternative measurement options.
Conclusion(s): This feasibility study demonstrated that a behaviour-change intervention focused on changing physical activity behaviour in people with MS is safe, feasible and acceptable.
Implications: A physiotherapist-led intervention consisting of four sessions that incorporate behaviour-change techniques has the potential to change physical activity behaviour in people with MS. A definitive trial of the intervention is warranted.
Keywords: physical activity, physiotherapy, multiple sclerosis
Funding acknowledgements: MS Society UK
Topic: Neurology
Ethics approval required: Yes
Institution: Brunel University London
Ethics committee: CHLS REC
Ethics number: 6181-NHS-Apr/2017-7016-2
All authors, affiliations and abstracts have been published as submitted.
