A randomised controlled trial to assess the safety, feasibility and acceptability of a behaviour-change intervention to change physical activity behaviour in people with MS: the iStep-MS trial

Completed (inferred)MS (type not specified)ISRCTN15343862

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • All participants will be assessed at baseline (week 0), 3 months (week 12), and 9 months (week 36). Safety: 1. Fatigue is assessed using the Modified Fatigue Impact Scale 2. Pain is assessed using the question regarding pain on the EQ-5D-5L 3. Number and type of adverse events and serious adverse events including falls and relapses throughout the duration of the participants' involvement in the

    RelapsesFatigueWalking and mobilityPainQuality of life (reported by participants)SafetyFeasibility

Other measures (1)

  • The following outcomes will be assessed in all participants at baseline (week 0), 3 months (week 12), and 9 months (week 36). These outcomes are the proposed outcomes that will be used to determine the effectiveness of the intervention if a definitive trial is conducted. 1. Light, moderate and vigorous physical activity assessed by the Actigraph GT3x+ accelerometer 2. Sedentary behaviour assesse

    FatigueWalking and mobilityPhysical functionQuality of life (reported by participants)

Who could take part

MS (type not specified)

Show the full criteria

Inclusion criteria

Inclusion: 1. A self-reported diagnosis of MS 2. Relapse free for the past 3 months 3. Independently ambulatory at a minimum within their home environment, with or without a walking aid 4. Free of unstable medical condition e.g. unstable angina 5. Ability to travel to the Berkshire MS therapy centre for the intervention 6. Fluent in English to a standard sufficient for completion of the trial assessment and intervention 7. An ability to comprehend and follow all instructions relating to participation in the study including providing informed consent, completing the outcome measures, or participating in the intervention Exclusion: 1. Pregnancy 2. Already participating in an interventional study

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 Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively, causing a range of symptoms including problems with balance and coordination and weakness in the arms or legs. Physical activity has multiple benefits for people with MS including improvements in physical, mental and social wellbeing. Despite the benefits of physical activity, the majority of people with MS don’t do very much physical activity. The main aims of this project are to develop a new way to help adults with MS to increase the amount of physical activity they do and reduce the amount of time they spend in sedentary behaviours (i.e. time spent in sitting and lying); and to determine if this approach is safe, enjoyable and easy to follow. Who can participate? People with MS who are able to walk independently with or without a walking aid within their house. What does the study involve? This project is being carried out in two phases. In phase 1 an programme is developed to increase physical activity levels and reduce sedentary behaviour among people with MS. This programme is based upon an intervention that has been successfully implemented among older adults in a primary care (GP level) setting. The researchers plan to work closely with a cognitive-behavioural therapy specialist and people with MS to develop the intervention over four months. The programme consists of physical activity sessions that incorporate behaviour-change techniques supported by a handbook, pedometer step-count feedback, and an individual physical activity diary. Once the programme has been developed the researchers train physiotherapists at the Berkshire MS Therapy Centre to deliver the physical activity consultations. In phase 2 of the study the researchers conduct a trial to test how safe and easy it is to follow the programme, and also to see if it is possible to carry out a large trial to investigate if the programme is effective. Participants are randomly allocated to one of those groups. Those in the first group continue as normal for the duration of the study. Those in the second group receive four sessions with a physiotherapist over three months. Physiotherapists use established techniques during the sessions, such as education about the consequences of physical inactivity, goal-setting, self-monitoring, creating action plans, and identifying social support, that have been shown to help people change their physical activity behaviour. In order to determine if the programme is safe and feasible for both the participants taking part and the physiotherapists delivering the programme, participant attendance is monitored and participants complete a range of questionnaires about their wellbeing. What are the possible benefits and risks? Participants may increase the amount of physical activity they do and reduce the amount of time they spend in sedentary behaviour after participating in the intervention, which may make them feel better and more energetic. There is a small risk that people may find the data collection procedures, in particular some aspects of the questionnaires that discuss fatigue or quality of life tiring or distressing. A very small number of people are sensitive to the adhesive tape used for the activity monitors, which is similar to that on a sticking plaster. Some people may find they are more tired or have muscle soreness from increasing the amount of activity they do. Where is the study run from? Berkshire MS Therapy Centre (UK) When is the study starting? January 2017 to December 2018 Who is funding the study? Multiple Sclerosis Society (UK) Who is the main contact? Dr Jennifer Ryan Jennifer.Ryan@brunel.ac.uk

Papers

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History

    1. Started

      May 2017

    2. Finished

      Dec 2018

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