Multiple Sclerosis
Conditions
Keywords
Physical Activity, Exercise, Physiotherapy
Brief summary
The study will be a pragmatic, single blind, randomised, controlled feasibility study, comparing 6 months of web-based physiotherapy plus usual care with usual care alone in pwMS. The study will recruit 90 pwMS from three UK Centres (30 from each centre); NHS Ayrshire and Arran, NHS Lothian, and Plymouth Hospitals NHS Trust. The aim of this study is to assess the feasibility of a randomised controlled trial examining the effectiveness of a six-month web-based physiotherapy programme and usual care compared to usual care alone, in people moderately affected by MS and to gather essential information for the planning of a definitive trial, which would evaluate both clinical and cost effectiveness of the intervention.
Detailed description
Following baseline assessments, both groups will be given an appointment with the physiotherapist to agree shared goals and to devise an individualised exercise programme based upon their needs and treatment goals. Participants will then be randomised to one of two groups. Participants randomised to the intervention group will receive their individualised exercise programme delivered via the web-based physio website. Participants will be asked to complete their exercise programme at least twice weekly. They will receive weekly standardised phone calls from the physiotherapist for the first two weeks of the programme. Every two weeks thereafter for the remainder of the 6 month intervention period the physiotherapist will review the exercise diary of each participant and remotely alter the participant's exercise programme as appropriate, by changing any combination of exercises, level of difficulty or number of repetitions. The number and type of exercises within the programme and duration to complete the exercise programme will be documented. Participants will be informed of any changes by standardised email. Participants randomised to the control group will receive a print out exercise sheet of their individualised exercise programme. Participants will be asked to complete their exercise programme at least twice weekly. Compliance will be captured using a home exercise diary. Participants will also receive a weekly phone call from the physiotherapist for the first two weeks to check on progress.
Interventions
BEHAVIORALExercise
web-based physio exercise programme
Sponsors
National Heatlh Service Ayrshire and Arran
NHS Lothian
University of Plymouth
University Hospital Plymouth NHS Trust
University of Glasgow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A confirmed diagnosis of MS * Known to a MS consultant in NHS Ayrshire and Arran, Lothian or Plymouth Hospitals NHS Trust * EDSS of 4 - 6.5 * Access to a personal computer/tablet or smart television with an email address and internet connection
Exclusion criteria
* Currently taking part in regular exercise (two or more times per week) and/or a regular physiotherapy programme * Poor cognitive function as assessed by a Mini Mental State Examination Score (MMSE) \<24 * Any significant change in medication (within the last 3 months) * Relapse within 3 months requiring treatment * Other significant co-morbidities for which exercise is contra-indicated * Unwilling to be randomised to intervention/control group * Currently participating in another clinical trial (rehabilitation or pharmacological)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance to the exercise programme | 9 months | Number of completed exercise diary entries |
| Two Minute Walk Test | 9 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | 9 months | — |
| Physical Activity | 9 months | Measured using the activPAL physical activity monitor |
| MS-Related Symptom Checklist | 9 months | — |
| Timed 25 Foot Walk | 9 months | — |
| Hospital Anxiety and Depression Scale | 9 months | — |
| Health related quality of life | 9 months | EQ-5D |
| Multiple Sclerosis Impact Scale | 9 months | — |
| Timed Up and Go | 9 months | — |
Countries
United Kingdom
Outcome results
None listed