Exercise Intensity and Immune Function in Multiple Sclerosis
1 other identifier
interventional
63
1 country
1
Brief Summary
This study aims to determine the effect of exercise intensity within a 15 week programme in moderately disabled people with multiple sclerosis (MS). Although earlier research has shown that exercise is safe and may improve health related factors such as mobility and fatigue, the intensity at which exercise offers the most benefit has not yet been defined. Participants will be randomly assigned to one of three groups - high intensity, moderate intensity or usual care. Participants in the exercising groups (high and moderate intensity) will take part in a supervised 15 week cycling exercise programme based in the Douglas Grant Rehabilitation Centre. Those assigned to the usual care (control) group will continue to receive their usual medical care and will not participate in the exercise programme. The acute immune response to exercise will also be measured. Participants from all three groups will be monitored regularly. Clinical outcomes of the study include immunological markers, exercise capacity, mobility, fatigue, quality of life and cognitive ability. These will be measured by a combination of blood tests, physical assessments and questionnaires. It is hypothesised that high intensity exercise will cause a favourable, anti-inflammatory response which will be associated with greater improvements in physical and psychological outcomes than both moderate intensity exercise and usual care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Nov 2014
Shorter than P25 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 15, 2014
October 1, 2014
8 months
October 8, 2014
October 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in serum brain-derived neurotrophic factor (BDNF) level
The level of brain-derived neurotrophic factor in participant serum will be determined by analysing blood samples using commercially available ELISA assays.
Chronic - Baseline, week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise
Secondary Outcomes (11)
Change in serum nerve growth factor (NGF) level
Chronic - Baseline, week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise
Change in serum interleukin-4 (IL-4) level
Chronic - Baseline (week 0), week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise
Change in serum interferon gamma (IFN-γ) level
Chronic - Baseline (week 0), week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise
Change in mobility
Baseline, weeks 5, 10, 15 and follow up (week 20)
Change in exercise capacity
Baseline, weeks 5, 10, 15 and follow up (week 20)
- +6 more secondary outcomes
Study Arms (3)
High intensity exercise
EXPERIMENTALHigh intensity exercise Participants will exercise at high intensity (70% VO2 peak) intermittently (30 seconds on, 30 seconds off) for 15 minutes, twice weekly for 15 weeks.
Moderate intensity exercise
EXPERIMENTALParticipants exercise at moderate intensity (35% VO2 peak) continuously for 15 minutes, twice weekly for 15 weeks.
Usual Care
NO INTERVENTIONParticipants receive usual medical care.
Interventions
Participants will exercise at high intensity (70% VO2 peak) intermittently (30 seconds on, 30 seconds off) for 15 minutes, twice weekly for 15 weeks. Workload may increase as the study progresses based on heart rate response.
Participants exercise at moderate intensity (35% VO2 peak) continuously for 15 minutes, twice weekly for 15 weeks. Workload may increase as the study progresses based on heart rate response.
Eligibility Criteria
You may qualify if:
- Clinically confirmed MS (according to the revised 2010 McDonald criteria) (Polman et al., 2011)
- Expanded disability status scale (EDSS) 3.0-5.0
You may not qualify if:
- Unable to consent due cognitive impairment or mental illness
- Immunomodulatory therapy in past 3 months
- Steroid therapy in the past 6 weeks
- Existence of medical contraindications for exercise i.e. cardiovascular or orthopaedic disease.
- Compounding neurological condition other than MS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Douglas Grant Rehabilitation Centre, Ayrshire Central Hospital
Irvine, Ayrshire, KA12 8SS, United Kingdom
Related Publications (2)
Heine M, Hoogervorst EL, Hacking HG, Verschuren O, Kwakkel G. Validity of maximal exercise testing in people with multiple sclerosis and low to moderate levels of disability. Phys Ther. 2014 Aug;94(8):1168-75. doi: 10.2522/ptj.20130418. Epub 2014 Mar 27.
PMID: 24677255BACKGROUNDCollett 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 May;17(5):594-603. doi: 10.1177/1352458510391836. Epub 2011 Jan 19.
PMID: 21247971BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Bell, MSc
University of the West of Scotland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postgraduate Student
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 15, 2014
Study Start
November 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
October 15, 2014
Record last verified: 2014-10