Exercise Intervention for Multiple Sclerosis: the Sheffield ExIMS tria
The effects of a pragmatic exercise therapy intervention on physical activity and important health outcomes influencing maintenance in people with multiple sclerosis (PWMS)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
1. Physical activity levels 2. Six-minute walking test All outcome measures will be taken at baseline, 12-weeks and at 6-months follow-up.
Walking and mobilityPhysical function
Other measures (1)
1. Neurological impairment and clinical functional mobility 2. Quality of life 3. Fatigue 4. Focus groups and interviews 5. Immunological analysis All outcome measures will be taken at baseline, 12-weeks and at 6-months follow-up.
FatigueWalking and mobilityQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over · EDSS 1.0 to 6.5
Show the full criteria
Inclusion criteria
Inclusion: 1. Clinical diagnosis of MS with an Expanded Disability Status Scale (EDSS) score of between 1.0 - 6.5, and able to walk 10 m distance 2. Aged 18 - 65 years, either sex 3. Participants must have been clinically stable for at least 4 weeks prior to entering the study 4. Participants on disease modifying therapy (interferon and glatiramer acetate) must have been stable on this treatment for at least 3 months prior to entering the study 5. Physically able to participate in some form of exercise three times per week 6. Able to provide written informed consent Exclusion: 1. Failure to meet any of the above inclusion criteria 2. Experiencing illness that impairs their ability to be physically active three times per week 3. Not willing to be randomised to either the exercise intervention or usual care control group 4. Living more than 20 miles from the trial centre 5. Already engaged in purposeful structured exercise or brisk walking exercise for equal to or greater than three times per week for equal to or greater than 30 minutes per session and have been so on a consistent basis during the previous six months
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord) in young adults. Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along them. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks and gradually destroys the myelin sheath (demyelination). This means that messages cannot travel along the nerves effectively causing a range of disabilities. A number of recent studies have shown that exercise is an effective way of improving functioning and mobility in people suffering from MS. The aim of this study is to investigate the effectiveness of a 12-week exercise programme in patients with mild to moderate MS. Who can participate? Adults with MS who are able to walk a distance of 10 meters. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group take part in a 12 week exercise programme. This involves two supervised and one home-based session per week for six weeks and then one supervised and two home-based sessions per week for six weeks. The sessions take place in small groups and involve short bouts of low to moderate intensity exercise. Those in the second group continue with their normal support alone during the study. At the start of the study and then again after 12 weeks and a further six months, participants in both groups complete a walking test to assess their abilities and complete a number of questionnaires in order to find out if their quality of life and other MS symptoms have improved. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Centre for Sport and Exercise Science, Sheffield Hallam University (UK) When is the study starting and how long is it expected to run for? January 2009 to January 2012 Who is funding the study? Multiple Sclerosis Society (UK) Who is the main contact? Dr John Saxton j.m.saxton@shu.ac.uk
Papers
Loading reviews and guidelines…
History
Started
Jan 2009
Finished
Jan 2012