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| Effective exercise for people with Multiple Sclerosis |
| Source of record | UK Trials |
| ISRCTN | ISRCTN89009719 |
| Date ISRCTN assigned | 15/11/2007 |
| Local reference number(s) | N/A |
| Public title | Effective exercise for people with Multiple Sclerosis |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Multiple Sclerosis |
| Study hypothesis | 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 |
| Design/methodology | Single-blind randomised non-controlled trial |
| Research ethics review | Ethics approval pending as of 17/10/2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Adults (over 18 years) 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 |
| Participants - exclusion criteria | 1. Serious medical condition or complication that would preclude safe exercise 2. Sudden change/relapse in MS 3. Cognitively unable to consent |
| Patient information material | |
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 01/07/2009 |
| Status of trial | Ongoing |
| Target number of participants | 60 |
| Interventions | 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). |
| Primary outcome measure(s) | Two-minute walk distance, measured at baseline, week 6 (half-way intervention), week 12 (end intervention) and week 24 (follow up). |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Multiple Sclerosis Society (UK) (grant ref: 840/06) |
| Sponsor name | Oxford Brookes University (UK) |
| Sponsor details | School of Life Sciences Gipsy lane campus Headington Oxford United Kingdom OX3 0BP |
| Sponsor telephone | +44 (0)1865 483293 |
| Sponsor email | lifesciences1@brookes.ac.uk |
| Sponsor website | http://www.brookes.ac.uk/ |
| Contact name | Dr Johnny Collett |
| Contact details | Movement science group School of life sciences Oxford Brookes University Gipsy Lane Headington Oxford United Kingdom OX10 0SB |
| Contact telephone | +44 (0)1865 483272 |
| Contact email | jcollett@brookes.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN89009719 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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