Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Following baseline assessments, participants will be randomly allocated to one of two groups in a 1:1 ratio. Allocation will be performed by an individual independent to the study according to a compu
Sponsors
Brunel University London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 criteria
Exclusion criteria: 1. Pregnancy 2. Already participating in an interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 trial (9 months). Participants will specifically asked if they have experienced a fall, relapse or other adverse event since their last contact with the research team at each assessment point (week 12 and week 36). Feasibility and acceptability 1. Attendance of participants at each intervention session 2. Completion of the handbook and diaries 3. Fidelity to the intervention using audio-recordings of 10% of each session (i.e. 1, 2, 3, and 4) for each therapist 4. Physiotherapist reported experience of delivering the intervention through semi-structured interviews 5. Participant reported experience of receiving the intervention through semi-structured interviews with 15 participants purposively sampled from the intervention group Feasibility of conducting a definitive trial: 1. Monitoring recruitment and retention rates 2. Identifying reasons for non-participation using a questionnaire distributed to people who refused to participate in the trial 3. Determining the feasibility and acceptability of randomisation by interviewing a random selection of 10 participants in the control group 4. Monitoring the completion rate of outcome measures relating to the effectiveness of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 assessed by ActivPAL3µ activity monitor 3. Self-reported physical activity and sedentary behaviour assessed by the International Physical Activity Questionnaire short-form 4. Fatigue assessed by the Modified Fatigue Impact Scale 5. Walking capability assessed by the Twelve Item MS Walking Scale 6. Self-efficacy assessed by the Multiple Sclerosis Self-Efficacy Scale 7. Quality of life as assessed by the EQ-5D-5L 8. Health service use assessed by the Adapted Client Service Receipt Inventory 9. Participation assessed by the Impact on Participation and Autonomy Questionnaire | — |
Countries
England, United Kingdom
Contacts
Public ContactJennifer Ryan
Outcome results
None listed