Changing physical activity and sedentary behaviour in people with MS to reduce fatigue: the iStep-MS study
| ISRCTN | ISRCTN16944301 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16944301 |
| IRAS number | 335169 |
| Secondary identifying numbers | CPMS 60234 |
- Submission date
- 08/04/2025
- Registration date
- 01/05/2025
- Last edited
- 20/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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?
March 2025 to February 2027
Who is funding the study?
Multiple Sclerosis Society (UK)
Who is the main contact?
Dr Daniel Bailey, daniel.bailey@brunel.ac.uk
Contact information
Public, Scientific, Principal Investigator
Brunel University of London, Kingston Lane, Uxbridge
London
UB8 3PH
United Kingdom
| Phone | +44 1895 265363 |
|---|---|
| daniel.bailey@brunel.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN16944301_PIS_v1.0_10April2025.pdf |
| Scientific title | Effectiveness and cost-effectiveness of the iStep-MS physical activity and sedentary behaviour intervention in people with MS: A randomised controlled trial |
| Study acronym | The iStep-MS study |
| Study objectives | Primary Objective: To investigate the effect of the iStep-MS intervention on fatigue in adults with MS at 9 months. Secondary Objectives: To investigate the effect of the iStep-MS intervention on the following outcomes at 3 and 9 months: 1. Fatigue (at 3 months) 2. Stepping time and number of steps per day 3. Standing time 4. Daily sitting and prolonged sitting time 5. Quality of life 6. Walking capability 7. Pain 8. Self-efficacy 9. Cost per quality adjusted life year 10. Cost per change in fatigue |
| Ethics approval(s) |
Approved 29/04/2025, London – Bloomsbury NHS Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8384; bloomsbury.rec@hra.nhs.uk), ref: 25/LO/0272 |
| Health condition(s) or problem(s) studied | Multiple Sclerosis |
| Intervention | The intervention will be delivered alongside usual care. The intervention will consist of four physical activity consultations (online or in person) delivered over 12 weeks by a qualified healthcare staff member. The consultations will be supported by a handbook. A Smartwatch will also be provided for use throughout the intervention to support self-monitoring of physical activity and sedentary behaviour, in addition to goal setting. The initial consultation (intervention start) will take place within approximately two weeks following randomisation. Subsequent consultations will take place approximately 2, 6 and 10 weeks following intervention start. Prior to each consultation the participant will be encouraged to complete a pre-reading section in the handbook. They will also be asked to record their activity prior to each consultation using the Smartwatch provided. Each physical activity consultation is expected to last for up to 45 minutes. During each consultation the participant’s progress and individual physical activity goals will be reviewed. Topics such as the benefits of increasing activity, participant’s feelings about increasing their walking, how participants plan to increase their physical activity and reduce sedentary behaviour, and their beliefs about achieving this will be discussed. The intervention deliverer and participant will work together to develop an action plan, set achievable goals and develop strategies to overcome any problems that may arise. |
| Intervention type | Behavioural |
| Primary outcome measure | Fatigue measured using the Modified Fatigue Impact Scale at baseline, 3 months and 9 months. |
| Secondary outcome measures | 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 baseline, 3 months and 9 months 5. Walking capability using the 12-item Multiple Sclerosis Walking Scale measured at baseline, 3 months and 9 months 6. Pain using the EQ-5D-5L pain scale measured at baseline, 3 months and 9 months 7. Self-efficacy using the Multiple Sclerosis Self-Efficacy Scale measured at baseline, 3 months and 9 months 8. Cost per quality-adjusted life year based on the EQ-5D-5L measured at baseline, 3 months and 9 months 9. Cost per change in fatigue based on the Modified Fatigue Impact Scale measured at baseline, 3 months and 9 months |
| Overall study start date | 01/03/2025 |
| Completion date | 28/02/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 198; UK Sample Size: 198 |
| 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. |
| 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. |
| Date of first enrolment | 15/07/2025 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Uxbridge
UB8 3NN
United Kingdom
Milton Keynes
MK3 6EN
United Kingdom
Harrow
HA1 3TS
United Kingdom
Bedford
MK41 9RX
United Kingdom
London
NW1 0PE
London
NW3 2QG
United Kingdom
Sponsor information
University/education
Kingston Lane, Uxbridge
London
UB8 3PH
England
United Kingdom
| Phone | +44 1895 266106 |
|---|---|
| kate.dunbar@brunel.ac.uk | |
| Website | https://www.brunel.ac.uk |
"ROR" |
https://ror.org/00dn4t376 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository: https://brunel.figshare.com/. Raw quantitative data will be made available following data analysis and will be available for a minimum of 10 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 10/04/2025 | 09/05/2025 | No | Yes |
Additional files
Editorial Notes
20/06/2025: The recruitment start date was changed from 01/06/2025 to 15/07/2025, and the following study participant centres were added: Neurophysiotherapy Service, Royal Free London NHS Foundation Trust, Camden Neurological and Stroke Service, and Bedford MS Therapy Centre.
09/05/2025: A participant information sheet was uploaded.
08/04/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
