Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment exercise
Sponsor University of Glasgow
Collaborator National Heatlh Service Ayrshire and Arran
Start date January 2015
End date November 2016
Trial size 90 participants
Trial identifier NCT02508961, 15/WS/0030

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants receive an online individualised exercise programme to complete over the internet twice per week. Exercises can be a combination of aerobic, strengthening and balance exercises. Participants receive a weekly phone call from a physiotherapist for the first two weeks to check on progress. After this, every 2 weeks online exercise diaries are remotely monitored by a physiotherapist and exercise programmes progressed as appropriate.
exercise
web-based physio exercise programme
(Active Comparator)
Participants receive printed exercise programme to complete twice per week. Exercises can be a combination of aerobic, strengthening and balance exercises. Participants receive a weekly phone call from a physiotherapist for the first two weeks to check on progress. Participants complete a paper exercise diary and after the first 2 weeks if they require a progression to their exercise programme they contact their physiotherapist.
exercise
web-based physio exercise programme

Primary Outcomes

Measure
Compliance to the exercise programme
time frame: 9 months
Two Minute Walk Test
time frame: 9 months

Secondary Outcomes

Measure
Timed 25 Foot Walk
time frame: 9 months
Timed Up and Go
time frame: 9 months
Berg Balance Scale
time frame: 9 months
Physical Activity
time frame: 9 months
MS-Related Symptom Checklist
time frame: 9 months
Multiple Sclerosis Impact Scale
time frame: 9 months
Hospital Anxiety and Depression Scale
time frame: 9 months
Health related quality of life
time frame: 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title WEB-Based Physiotherapy for People With Multiple Sclerosis
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Glasgow.