Exercise Intervention for Multiple Sclerosis: the Sheffield ExIMS trial

Not Applicable

Completed

Conditions: Multiple sclerosis
Nervous System Diseases

Registration Number: ISRCTN41541516

Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Clinical diagnosis of MS with an Expanded Disability Status Scale (EDSS) score of between 1.0 - 6.5, and able to walk 10 m distance
2. Aged 18 - 65 years, either sex
3. Participants must have been clinically stable for at least 4 weeks prior to entering the study
4. Participants on disease modifying therapy (interferon and glatiramer acetate) must have been stable on this treatment for at least 3 months prior to entering the study
5. Physically able to participate in some form of exercise three times per week
6. Able to provide written informed consent

Exclusion Criteria

1. Failure to meet any of the above inclusion criteria
2. Experiencing illness that impairs their ability to be physically active three times per week
3. Not willing to be randomised to either the exercise intervention or usual care control group
4. Living more than 20 miles from the trial centre
5. Already engaged in purposeful structured exercise or brisk walking exercise for equal to or greater than three times per week for equal to or greater than 30 minutes per session and have been so on a consistent basis during the previous six months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Physical activity levels <br>2. Six-minute walking test<br><br>All outcome measures will be taken at baseline, 12-weeks and at 6-months follow-up.

Secondary Outcome Measures

Name	Time	Method
1. Neurological impairment and clinical functional mobility<br>2. Quality of life<br>3. Fatigue<br>4. Focus groups and interviews<br>5. Immunological analysis<br><br>All outcome measures will be taken at baseline, 12-weeks and at 6-months follow-up.