Multiple Sclerosis Nervous System Diseases
Conditions
Interventions
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 s
Sponsors
Brunel University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue measured using the Modified Fatigue Impact Scale at baseline, 3 months and 9 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactDaniel Bailey
Outcome results
None listed