Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in functional capacity measured as a composite score of the six minute walk test and the 5x sit to stand test (5STS).
Study Overview
Brief Summary
This study wants to investigate whether exercise booster sessions applied in the follow-up period after an exercise intervention can increase the sustainability of exercise induced effects in persons with multiple sclerosis.
The study will be a randomized, multi-site, controlled trial. Participants will from the beginning be allocated to either aerobic training group, resistance training group or control group. After a 12 week exercise intervention, the exercise groups will be additionally randomized to receive either exercise booster sessions + standard care or just standard care in the 40 week follow up period.
It is hypothesized that exercise booster sessions can increase the sustainability of exercise induced effects.
Detailed Description
MS is a chronic, autoimmune, and inflammatory disease of the central nervous system, exemplified through marked demyelination and axonal loss. As a result, symptoms such as fatigue, numbness, weakness, depression, walking difficulties and spasticity frequently appear.
Although there is no cure for MS, several disease-modifying therapies are available. These can potentially slow the progression of disabilities and reduce the overall disease burden. This is of great interest from both an individual perspective, where increased disability is associated with a lowered health-related quality of life, and from a societal perspective, where increased disability is associated with larger costs.
Over the past decades exercise has been shown to be safe, tolerable and beneficial in persons with MS (PwMS). Hence, it is known to be an effective way of treating symptoms such as fatigue7, muscle weakness, walking impairments and depression. As with other chronic diseases, exercise for PwMS has been proposed as "medicine". However, in order to benefit from the positive effects of any kind of treatment (i.e. most medical drugs or exercise) one has to adhere to the prescriptions of the treatment (i.e. dose and timing). Despite all the potential benefits of exercise therapy for PwMS, one of the major challenges relate to long-term maintenance of exercise efforts.
An emerging concept that may hold the potential to increase the sustainability of exercise therapy is supervised "exercise booster sessions" (i.e. training sessions provided regularly throughout the follow-up period, to sustain effects of the preceding exercise intervention). These can be placed regularly during the follow-up period, where patients attend a number of supervised high-intensity exercise sessions, hereby trying to boost the effects of the preceding exercise intervention. Furthermore, exercise booster sessions can potentially motivate the patient to keep exercising throughout the follow up period.
However, the optimal way of utilizing this concept is still not fully understood, and has not yet been tried in neurological patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A definite diagnosis of MS, according to the McDonald criteria
- •Walking <650m on 6MWT.
- •Exercising ≤ two sessions per week of moderate-to-high intensity during the past six months.
Exclusion Criteria
- •Comprise comorbidities (cardiovascular-, respiratory-, orthopedic- or other neurological diseases.)
Arms & Interventions
Aerobic training control group
Will receive 12 weeks of aerobic training followed by standard care in the 40 follow up period
Intervention: Systematic aerobic training (Combination Product)
Aerobic training booster group
Will receive 12 weeks of aerobic training followed by booster sessions + standard care in the 40 follow up period
Intervention: Systematic aerobic training (Combination Product)
Aerobic training booster group
Will receive 12 weeks of aerobic training followed by booster sessions + standard care in the 40 follow up period
Intervention: Aerobic training booster sessions (Combination Product)
Resistance training booster group
Will receive 12 weeks of resistance training training followed by booster sessions + standard care in the 40 follow up period
Intervention: Systematic resistance training (Combination Product)
Resistance training booster group
Will receive 12 weeks of resistance training training followed by booster sessions + standard care in the 40 follow up period
Intervention: Resistance training booster sessions (Combination Product)
Resistance training control group
Will receive 12 weeks of resistance training followed by standard care in the 40 follow up period
Intervention: Systematic resistance training (Combination Product)
Control group
Will receive standard care throughout the study
Outcomes
Primary Outcomes
Change in functional capacity measured as a composite score of the six minute walk test and the 5x sit to stand test (5STS).
Time Frame: Baseline,12 weeks and 52 weeks.
The six minute walk test it the distance covered during a six-minute maximal walking test. The 5STS is the time used to stand up from a chair and sit again five times.
Secondary Outcomes
- Change in functional capacity measured by the Multiple Sclerosis Functional Composite (MSFC)(Baseline, 12 weeks and 52 weeks.)
- Change in functional capacity measured by the Six spot step test (SSST)(Baseline, 12 weeks and 52 weeks.)