Contact information
Type
Scientific
Primary contact
Dr Johnny Collett
ORCID ID
Contact details
Movement science group
School of life sciences
Oxford Brookes University
Gipsy Lane
Headington
Oxford
OX10 0SB
United Kingdom
+44 (0)1865 483272
jcollett@brookes.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effective exercise for people with Multiple Sclerosis: a single-blind randomised non-controlled trial
Acronym
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
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
Added 11/02/2009: National Research Ethics Service, Oxfordshire REC A gave approval on the 7th May 2008 (ref: 08/H0604/3)
Study design
Single-blind randomised non-controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/06/2008
Overall trial end date
01/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Serious medical condition or complication that would preclude safe exercise
2. Sudden change/relapse in MS
3. Cognitively unable to consent
Recruitment start date
01/06/2008
Recruitment end date
01/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Movement science group
Oxford
OX10 0SB
United Kingdom
Sponsor information
Organisation
Oxford Brookes University (UK)
Sponsor details
School of Life Sciences
Gipsy Lane Campus
Headington
Oxford
OX3 0BP
United Kingdom
+44 (0)1865 483293
lifesciences1@brookes.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Multiple Sclerosis Society (UK) (grant ref: 840/06)
Alternative name(s)
MS Society
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21247971
Publication citations
-
Results
Collett J, Dawes H, Meaney A, Sackley C, Barker K, Wade D, Izardi H, Bateman J, Duda J, Buckingham E, Exercise for multiple sclerosis: a single-blind randomized trial comparing three exercise intensities., Mult. Scler., 2011, 17, 5, 594-603, doi: 10.1177/1352458510391836.