CompletedInterventional

Changing physical activity and sedentary behaviour in people with MS to reduce fatigue: the iStep-MS study

The iStep-MS study aims to help people with Multiple Sclerosis (MS) reduce tiredness by encouraging more physical activity and less sitting. Many people with MS find being active challenging, but it can greatly improve well-being. Researchers will test a new program, iStep-MS, that includes four support sessions with a healthcare professional, a handbook, and a smartwatch. Participants will be randomly placed into two groups: one receiving the iStep-MS program and another continuing their usual care. Researchers will measure changes in activity levels, tiredness, walking ability, and quality of life over nine months. This study hopes to discover better ways to manage MS fatigue.

At a glance

Status

Completed

Sponsor

Brunel University of London

Enrolment target

198

Start

10 Aug 2025

Estimated completion

30 Apr 2026

Multiple Sclerosis

What is this study about?

Many people living with Multiple Sclerosis (MS) often feel very tired and find it hard to be physically active, even though being active can really help with their physical, mental, and social health. This study, called iStep-MS, wants to explore if a new program can effectively help people with MS become more active and spend less time sitting, which researchers hope will reduce their fatigue.

Researchers will involve 198 people with MS from different care settings. Each participant will first have some measurements taken. Then, everyone will be randomly assigned to one of two groups. One group will continue with their normal routines, while the other will take part in the iStep-MS program. This random choice helps the study be fair and makes sure the results are reliable.

The iStep-MS program includes four meetings over three months with a healthcare professional, either in person or online. Participants will also get a handbook with advice and tasks, and a smartwatch to help them track their activity, set goals, and get reminders to move. Over nine months, researchers will check if participants' activity levels, tiredness, walking ability, pain, and general quality of life change.

Key takeaways

The iStep-MS study aims to help people with MS manage fatigue through physical activity.
It tests a new program including support meetings, a handbook, and a smartwatch.
Participants will be randomly assigned to either the program or usual care.
The study measures activity levels, fatigue, and quality of life over nine months.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to have MS and have been feeling tired because of your MS for the past month. Your tiredness will be checked using a special questionnaire.

It's important that you haven't had an MS relapse in the last three months. A relapse means new or returning symptoms lasting more than 24 hours. You should also be able to move around without too much difficulty, ranging from no disability to needing two walking aids like crutches.

You must be able to speak and understand English well enough to give your permission and fully take part in the study activities. You also need to be able to travel to a study centre or attend online appointments. You shouldn't have any serious health problems that would make being active unsafe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have Multiple Sclerosis (MS)?
Have you felt tired due to your MS in the last month?
Have you been free from an MS relapse for the past three months?
Can you move around without severe difficulty (e.g., you can walk 20 metres with two aids or less)?
Can you speak and understand English well enough to participate fully?
Are you able to attend appointments in person or online?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have some measurements taken. After that, you'll be randomly put into one of two groups. If you're in the 'usual care' group, you'll just carry on as normal. If you're in the 'iStep-MS' group, you'll have four meetings over three months with a healthcare professional. These meetings can be in person or online. You'll also get a handbook and a smartwatch to help you.

Throughout the study, you'll have measurements taken again at 3 months and 9 months to see how things have changed. These measurements will check your activity, steps, sitting time, tiredness, walking ability, pain, and quality of life. Some people might also be asked to take part in group discussions. The total study will last for nine months.

Potential risks and benefits

While we can't guarantee you'll personally benefit, joining this study offers a chance to get support in increasing your physical activity. Being more active and sitting less may help you feel better generally. We hope the information gathered will lead to better ways to help people with MS in the future. There's a small chance you might find answering questionnaires tiring or upsetting; you can take breaks if this happens. A very few people might react to the sticky tape used for the activity monitor, similar to a plaster. If this happens, you can remove it or try it on your other leg. Remember, taking part is completely your choice, and you can leave the study at any time without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Hillingdon Hospitals NHS Foundation Trust
City only
Uxbridge, England
Milton Keynes Neuro Conditions Service
City only
Milton Keynes, England
Harrow MS Therapy Centre
City only
Harrow, England
Bedford MS Therapy Centre
City only
Bedford, England
Camden Neurological and Stroke Service
Unverified
London NO COUNTRY SPECIFIED, assuming England, England
Neurophysiotherapy Service, Royal Free London NHS Foundation Trust
City only
London, England
Integrated Neurological Service
Unverified
Twickenham, England

Common questions

What is the main goal of the iStep-MS study?

To see if a new program can help people with MS reduce their fatigue by becoming more active and sitting less.

Will I have to take any new medicines?

No, this study focuses on physical activity and behaviour changes, not new medications.

How long will I need to be involved in the study?

The study will involve measurements at the beginning, 3 months, and 9 months, lasting a total of nine months.

What kind of support will I get if I'm in the iStep-MS group?

You'll have four meetings with a healthcare professional, a handbook, and a smartwatch to help you set goals and track your activity.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

How to find out more

Daniel Bailey

daniel.bailey@brunel.ac.uk +44 1895 265363 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.