{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T14:13:47Z","timestamp":1788444827026,"version":"build-2803163510"},"reference-count":60,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T00:00:00Z","timestamp":1784505600000},"content-version":"unspecified","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Multiple Sclerosis Society in the UK","award":["198"],"award-info":[{"award-number":["198"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,7,5]]},"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Regular physical activity and limiting sedentary behaviour are important aspects in managing multiple sclerosis (MS). Fatigue is a common and disabling symptom in MS, contributing to impairments in activities of daily living and poorer quality of life. This study aims to determine the effectiveness of a physical activity and sedentary behaviour intervention, called iStep-MS, for reducing fatigue in people with MS when delivered across the MS care pathway.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a multicentre, two-arm randomised controlled superiority trial with embedded economic and process evaluations. The study will take place across South-East England in acute and community National Health Service settings and charity-funded MS and neurological therapy centres. Intervention deliverers will include a range of healthcare staff such as physiotherapists, occupational therapists, therapy assistants, nurses and exercise therapists. A target sample size of n=198 participants will be randomised 1:1 to the intervention (iStep-MS behaviour change intervention plus usual care) or control (usual care only) arms. Participants will be adults with any type of MS, experiencing MS-related fatigue, relapse-free for &gt;3 months, with a Self-Reported Disability Status Scale category of \u22643.5 (no disability to moderate disability) or 4\u20136.5 (significant disability). The iStep-MS intervention includes four one-to-one consultation sessions in-person or online with an intervention deliverer over 3 months, incorporating behaviour change techniques aimed at increasing physical activity and reducing sedentary behaviour. The consultations are supported by a handbook designed to help individuals with MS set goals and achieve behavioural changes and a wearable activity tracker for self-monitoring. Outcomes (assessed at baseline, 3 months and 9 months) include self-reported fatigue, quality of life, MS-impact, walking capability, pain, self-efficacy and waist circumference. Sitting, standing and stepping will be measured over 8 days using the activPAL4 device. A process evaluation will assess intervention acceptability, adherence and fidelity, including questionnaires and focus groups with participants and deliverers. A cost-effectiveness analysis will evaluate the value for money of the intervention against usual care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been granted by the NHS London\u2014Bloomsbury Research Ethics Committee (reference 25\/LO\/0272). Results will be disseminated in scientific journals, conferences and to the wider public (eg, newsletters and social media).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN16944301\">ISRCTN16944301<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-121358","type":"journal-article","created":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T15:30:28Z","timestamp":1784561428000},"page":"e121358","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical and cost-effectiveness of the iStep-MS physical activity and sedentary behaviour intervention for managing fatigue in people with multiple sclerosis: protocol for a multicentre randomised controlled trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"isrctn16944301","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3772-630X","authenticated-orcid":false,"given":"Daniel P","family":"Bailey","sequence":"first","affiliation":[{"name":"Centre for Physical Activity in Health and Disease, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, England, UK"},{"name":"Department of Sport, Health and Exercise Sciences, Brunel University of London, Uxbridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9957-4025","authenticated-orcid":false,"given":"Emma","family":"Norris","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, 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