Effectiveness and cost-effectiveness of the iStep-MS physical activity and sedentary behaviour intervention in people with MS: A randomised controlled trial

Ongoing (inferred)MS (type not specified)ISRCTN16944301

What it found

Still running

No result yet.

What it measured

Main measures

  • Fatigue measured using the Modified Fatigue Impact Scale at baseline, 3 months and 9 months.

    Fatigue

Other measures (1)

  • 1. Stepping time and number of steps per day using the activPAL activity monitor measured at baseline, 3 months and 9 months 2. Standing time using the activPAL activity monitor measured at baseline, 3 months and 9 months 3. Daily sitting and prolonged sitting time using the activPAL activity monitor measured at baseline, 3 months and 9 months 4. Quality of life using the EQ-5D-5L measured at base

    FatigueWalking and mobilityPhysical functionPainQuality of life (reported by participants)

Who could take part

MS (type not specified)

Show the full criteria

Inclusion criteria

Inclusion: Current key inclusion criteria as of 06/02/2026: 1. Experiencing MS-related fatigue over the past four weeks, as indicated by a Modified Fatigue Impact Scale (MFIS) score of one or more of the following: 1.1. >35.5 for total MFIS score 1.2. >18.5 for combined physical and social subscales 1.3. >15.5 for cognitive subscale 2. Experiencing MS-related fatigue over the past four weeks as indicated by a score of ≥ 38 on the Modified Fatigue Impact Scale (MFIS). 3. Relapse-free for the past 3 months; a relapse will be defined as ‘the appearance of new symptoms, or the return of old symptoms, for a period of 24 hours or more, in the absence of a change in core body temperature or infection’. 4. Self-Reported Disability Status Scale (SRDSS) category of ≤ 3.5 (no disability to moderate disability) or 4-6.5 (significant disability). The SRDSS represents mobility-centred descriptions of the Expanded Disability Status Scale (EDSS), with the SRDSS categories for eligibility here aligning to EDSS scores of 1.0 “no disability, very small sign that one function isn’t normal” to 6.5 “you can walk 20 metres with two aids (e.g. crutches, sticks, frame etc) without stopping for rests”. 5. Free of contraindications to participate in physical activity as defined by the local site criteria. 6. Free of unstable medical conditions e.g. unstable angina. 7. Able to communicate in English to a standard sufficient to provide informed consent and take part fully in the study protocols. 8. Able to travel to a study centre or attend online consultations for the intervention. Previous key inclusion criteria: 1. Diagnosis of MS. 2. Experiencing MS-related fatigue over the past four weeks as indicated by a score of ≥ 38 on the Modified Fatigue Impact Scale (MFIS). 3. Relapse free for the past 3 months; a relapse will be defined as ‘the appearance of new symptoms, or the return of old symptoms, for a period of 24 hours or more, in the absence of a change in core body temperature or infection’. 4. Expanded Disability Status Scale (EDSS) score of 1.0 “no disability, very small sign that one function isn’t normal” to 6.5 “you can walk 20 metres with two aids (crutches, sticks or frame etc) without stopping for rests”; this range allows inclusivity across different disability levels, in line with the iStep-MS feasibility study. 5. Free of contraindications to participate in physical activity as defined by the local site criteria. 6. Free of unstable medical conditions e.g. unstable angina. 7. Able to communicate in English to a standard sufficient to provide informed consent and take part fully in the study protocols. 8. Able to travel to a study centre or attend online consultations for the intervention. Exclusion: Current key exclusion criteria as of 06/02/2026: 1. SRDSS category of ≥ 7.0 “Unable to walk beyond approximately 5 m even with aid. Essentially restricted to a wheelchair; though wheels a standard wheelchair and able to get in and out alone. Up and about in wheelchair some 12 hours a day”. 2. Currently pregnant or become pregnant during the study. 3. Already participating in an interventional clinical trial (in order to minimise the impact of potential confounding variables on the study outcomes). 4. Do not have the capacity to provide informed consent. Previous key exclusion criteria: 1. EDSS score ≥ 7.0 “Unable to walk beyond approximately 5m even with aid. Essentially restricted to a wheelchair; though wheels a standard wheelchair and able to get in and out alone. Up and about in wheelchair some 12 hours a day”. 2. Currently pregnant or become pregnant during the study. 3. Already participating in an interventional clinical trial (in order to minimise the impact of potential confounding variables on the study outcomes). 4. Do not have capacity to provide informed consent.

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims Physical activity has many benefits for people living with multiple sclerosis (MS) including improvements in physical, mental and social wellbeing. Despite these benefits, the majority of people with MS don’t do very much physical activity and spend a lot of their day sitting. The aim of this project is to test how effective a new physical activity intervention is, called iStepMS, for improving fatigue in people with MS. Participants will have a range of measurements taken before the intervention, then 3 and 9 months later. After the first measurements, participants will be randomly entered into the intervention group or a usual care control group. Who can participate? We will do the study with 198 people living with MS. We will recruit participants from an MS therapy centre, a hospital and community health service. What does the study involve? The 99 participants in the control group will be asked to continue what they are doing as normal. The 99 people in the intervention group will receive the iStep-MS intervention. iStep-MS will involve four physical activity consultations over 3 months with a qualified healthcare team member at a hospital, community NHS service or charity-funded MS centre. The consultations will be in-person or online and use techniques known to support more physical activity and less sitting. Participants will receive the iStep-MS handbook that provides readings and tasks to do before the consultations and provides guidance on setting goals and planning when, where and how to do physical activity and reduce sitting. They will also be given a Smartwatch activity tracker to monitor their physical activity, set goals and receive reminders to move. To test if the programme is effective, we will see if the following measurements change: physical activity, steps, sitting time, fatigue, walking capability, pain and quality of life. We will also use focus groups to find out about the experiences of participants and staff delivering iStep-MS. What are the possible benefits and risks of participating? We cannot promise that taking part will lead to benefits, but the study will give participants an opportunity to increase their physical activity and to easily access support designed to help them gradually increase their physical activity. Participants may feel better as a result of doing more physical activity and spending less time sitting. We hope the information we get from this study will help improve the treatments for people with MS in the future. There is a small risk that people may find completing the questionnaires tiring or distressing. If this happens they can take a break and then continue if they are happy to. A very small number of people are sensitive to the adhesive tape used for the activity monitoring, which is similar to that on a sticking plaster. If this happens, we will advise participants to remove the tape and attach the monitor to the other thigh or to stop wearing it. Participation is voluntary and participants may withdraw at any point without this decision affecting their normal care. Where is the study run from? Brunel University of London (UK) When is the study starting and how long is it expected to run for? August 2025 to August 2027 Who is funding the study? Multiple Sclerosis Society (UK) Who is the main contact? Dr Daniel Bailey, daniel.bailey@brunel.ac.uk

Papers

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History

    1. Started

      Aug 2025

    2. Finished

      Aug 2027

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