Condition category
Nervous System Diseases
Date applied
17/10/2007
Date assigned
15/11/2007
Last edited
11/10/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.brookes.ac.uk/

Funders

Funder type

Charity

Funder name

Multiple Sclerosis Society (UK) (grant ref: 840/06)

Alternative name(s)

MS Society

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21247971

Publication citations

  1. 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.

Additional files

Editorial Notes