Effective exercise for people with Multiple Sclerosis

ISRCTN	ISRCTN89009719
DOI	https://doi.org/10.1186/ISRCTN89009719
Protocol serial number	N/A
Sponsor	Oxford Brookes University (UK)
Funder	Multiple Sclerosis Society (UK) (grant ref: 840/06)

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

Movement science group
School of life sciences
Oxford Brookes University
Gipsy Lane
Headington
Oxford
OX10 0SB
United Kingdom

Phone	+44 (0)1865 483272
Email	jcollett@brookes.ac.uk

Study information

Primary study design	Interventional
Study design	Single-blind randomised non-controlled trial
Secondary study design	Non randomised controlled trial
Study type	Participant 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(s)	Two-minute walk distance, measured at baseline, week 6 (half-way intervention), week 12 (end intervention) and week 24 (follow up).
Key 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
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Movement science group

Oxford
OX10 0SB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes