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Abstract
Introduction Although physical activity may reduce disease burden, fatigue and disability, and improve quality of life among people with multiple sclerosis (MS), many people with MS are physically inactive and spend significant time in sedentary behaviour. Behaviour change interventions may assist people with MS to increase physical activity and reduce sedentary behaviour. However, few studies have investigated their effectiveness using objective measures of physical activity, particularly in the long term. Further, interventions that have proven effective in the short term may not be feasible in clinical practice because of the large amount of support provided. The iStep-MS trial aims 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 and analysis Sixty people with MS will be randomised (1:1 ratio) to receive a 12-week intervention or usual care only. The intervention consists of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Outcomes assessed at baseline, 12 weeks and 9 months are physical activity (ActiGraph wGT3X-BT accelerometer), sedentary behaviour (activPAL3µ), self-reported activity and sitting time, walking capability, fatigue, self-efficacy, participation, quality of life and health service use. The safety of the intervention will be determined by assessing change in pain and fatigue and the incidence of adverse events during the follow-up period. A parallel process evaluation will assess the feasibility and acceptability of the intervention through assessment of fidelity to the programme and semistructured interviews exploring participants’ and therapists’ experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on quality of life and resource use.
Ethics and dissemination Research ethics committee approval has been granted from Brunel University London. Results of the trial will be submitted for publication in journals and distributed to people with MS and physiotherapists.
Trial registration number ISRCTN15343862 (doi 10.1186/ISRCTN15343862). Protocol version: 1.0; Pre-results.
- multiple sclerosis
- neurology
- public health
- rehabilitation medicine
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors JMR and MN conceived the study and are co-chief investigators. JMR, MN, JF, AS, CK, NA, CV, WH, MA, LDS and GL designed the study. DB, LD, JF, MN and JMR developed the intervention and handbook. JMR will lead the running of the trial. MN will lead the process evaluation. NA will lead the evaluation of the feasibility of the economic evaluation. All authors have read and approved the final manuscript.
Funding This study is funded by a project grant from the MS Society, UK (award reference: 53).
Competing interests None declared.
Ethics approval Ethical approval has been granted by College of Health and Life Sciences Research Ethics Committee (REC) in Brunel University London (6181-NHS-Apr/2017-7016-2).
Provenance and peer review Not commissioned; externally peer reviewed.