Effective exercise for people with Multiple Sclerosis
| ISRCTN | ISRCTN89009719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89009719 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/10/2007
- Registration date
- 15/11/2007
- Last edited
- 11/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Johnny Collett
Scientific
Scientific
Movement science group
School of life sciences
Oxford Brookes University
Gipsy Lane
Headington
Oxford
OX10 0SB
United Kingdom
| Phone | +44 (0)1865 483272 |
|---|---|
| jcollett@brookes.ac.uk |
Study information
| Study design | Single-blind randomised non-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effective exercise for people with Multiple Sclerosis: a single-blind randomised non-controlled trial |
| Study objectives | To examine the effect of three different forms of exercise delivered over a three-month period. Three exercise groups will perform the same amount of exercise within sessions but it will be delivered in different ways: 1. Shorter and hard (anaerobic) 2. Longer and easy (aerobic) 3. A combination of both aerobic and anaerobic exercises Please note that as of 11/02/2009 this record was updated to include amended trial dates. The initial trial dates at the time of registration were: Initial anticipated start date: 01/11/2007 Initial anticipated end date: 01/07/2009 |
| Ethics approval(s) | Added 11/02/2009: National Research Ethics Service, Oxfordshire REC A gave approval on the 7th May 2008 (ref: 08/H0604/3) |
| Health condition(s) or problem(s) studied | Multiple sclerosis |
| Intervention | Three exercise groups will perform the same amount of exercise within sessions delivered in different ways: 1. Shorter and hard (anaerobic) 2. Longer and easy (aerobic) 3. A combination of both aerobic and anaerobic exercises Total duration of treatment will be the same for each treatment arm. Each participant will have 20 minute exercise sessions 3 x per week for 12 weeks (36 sessions). The total relative work performed (determined from baseline fitness assessment) at each exercise session will be the same for each exercise group but the intensity and delivery of the exercise with be different. An assessment will take place at week 24 (12 weeks after end of intervention). |
| Intervention type | Other |
| Primary outcome measure | Two-minute walk distance, measured at baseline, week 6 (half-way intervention), week 12 (end intervention) and week 24 (follow up). |
| Secondary outcome measures | 1. Questionnaires: 1.1. Barthel Index of independence in activities of daily living 1.2. Fatigue Severity Scale (FSS): self reported fatigue levels 1.3. Physical Activity Questionnaire in the Elderly (PASE): self reported activity levels in home, work and social environments 1.4. General Health Status questionnaire - 36-item Short Form health survey (SF-36): Patient-completed health status measure 1.5. Short Orientation Memory Concentration scale (SOMC): measure of orientation, memory and concentration 1.6. Subjective vitality individual difference scale: self reported energy levels scale 1.7. Self efficacy scale: confidence to take complete exercise scale 2. Anthropodmetry: weight (kg), height (m) and leg-length (cm) (anterior superior iliac spine to med. Malleolus) 3. Muscle performance: extensor leg power - measurement of leg extension power in sitting 4. Mobility: 4.1. Step count during 8 days measured with a Step Activity Monitor (watch sized device worn on ankle)* 4.2. Timed up and go test (sit to stand from chair and walk 5 metres) 4.3. During 2 minute walk test (walking characteristics (step time and length) recorded with a small accelerometer worn on back) 5. Hydration status: urine analysis 6. Blood test: of neurotrophic factors (proteins associated with brain function) and immune markers* 7. Fitness test: 7.1. Heart Rate (HR): heart rate monitor 7.2. Blood pressure: arm cuff measure 7.3. Rating of perception of effort and symptoms (Breathing and Leg effort): self report 7.4. Enjoyment S-bipolar scale: self report 7.5. Rate of oxygen consumption (metabolism): measurement of expired air 7.6. Muscle response to exercise (blood lactate levels): finger prick (capillary) blood samples 8. Qualative analysis of focus group meetings and interviews Secondary outcome measures will be measured at baseline, week 6 (half-way intervention), week 12 (end intervention) and week 24 (follow up). *Neurotrophic factors, immune markers and step activity will only be measured at baseline and end intervention |
| Overall study start date | 01/06/2008 |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Adults (over 18 years, either sex) with Multiple Sclerosis (MS) 2. Able to sit and pedal on a cycle ergometer and complete 60 seconds unloaded exercise 3. Ambulatory with/without a walking aid |
| Key exclusion criteria | 1. Serious medical condition or complication that would preclude safe exercise 2. Sudden change/relapse in MS 3. Cognitively unable to consent |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Movement science group
Oxford
OX10 0SB
United Kingdom
OX10 0SB
United Kingdom
Sponsor information
Oxford Brookes University (UK)
University/education
University/education
School of Life Sciences
Gipsy Lane Campus
Headington
Oxford
OX3 0BP
England
United Kingdom
| Phone | +44 (0)1865 483293 |
|---|---|
| lifesciences1@brookes.ac.uk | |
| Website | http://www.brookes.ac.uk/ |
"ROR" |
https://ror.org/04v2twj65 |
Funders
Funder type
Charity
Multiple Sclerosis Society (UK) (grant ref: 840/06)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2011 | Yes | No |
