{
  "abstract": "Introduction 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.Methods and analysis 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 >3 months, with a Self-Reported Disability Status Scale category of ≤3.5 (no disability to moderate disability) or 4–6.5 (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.Ethics and dissemination Ethical approval has been granted by the NHS London—Bloomsbury 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).Trial registration number ISRCTN16944301.",
  "authors": [
    {
      "affiliations": [
        "Centre for Physical Activity in Health and Disease, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, England, UK",
        "Department of Sport, Health and Exercise Sciences, Brunel University of London, Uxbridge, UK"
      ],
      "name": "Daniel P Bailey"
    },
    {
      "affiliations": [
        "Department of Health Sciences, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, UK"
      ],
      "name": "Emma Norris"
    },
    {
      "affiliations": [
        "Centre for Physical Activity in Health and Disease, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, England, UK",
        "Department of Sport, Health and Exercise Sciences, Brunel University of London, Uxbridge, UK"
      ],
      "name": "Myles D LeWarne"
    },
    {
      "affiliations": [
        "Centre for Physical Activity in Health and Disease, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, England, UK",
        "Department of Sport, Health and Exercise Sciences, Brunel University of London, Uxbridge, UK"
      ],
      "name": "Luke Cerexhe"
    },
    {
      "affiliations": [
        "Department of Health Sciences, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, UK"
      ],
      "name": "Nana Anokye"
    },
    {
      "affiliations": [
        "Department of Health Sciences, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, UK"
      ],
      "name": "Amrit Banstola"
    },
    {
      "affiliations": [
        "Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, England, UK"
      ],
      "name": "Joe Gwatsvaira"
    },
    {
      "affiliations": [
        "College of Health and Life Sciences, Brunel University of London, Uxbridge, UK"
      ],
      "name": "Meriel Norris"
    },
    {
      "affiliations": [
        "School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland"
      ],
      "name": "Jennifer Ryan"
    },
    {
      "affiliations": [
        "Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, England, UK",
        "Wolfson Institute of Population Health, Queen Mary University of London, London, UK"
      ],
      "name": "Beth Stuart"
    },
    {
      "affiliations": [
        "Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, England, UK"
      ],
      "name": "Ann Thomson"
    },
    {
      "affiliations": [
        "Department of Health Sciences, College of Health, Medicine and Life Sciences, Brunel University of London, Uxbridge, UK"
      ],
      "name": "Cherry Kilbride"
    }
  ],
  "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",
  "uid": "33a2a922-3193-578e-af4b-dc4421ae0a61"
}