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Clinical trial

Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.

ID
Name
Laurits_Madsen_PhD
Description
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.
Trial arms
Trial start
2021-08-01
Estimated PCD
2024-09-01
Trial end
2024-09-01
Status
Recruiting
Treatment
Systematic aerobic training
Two-three weekly supervised aerobic exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Arms:
Aerobic training booster group, Aerobic training control group
Systematic resistance training
Two-three weekly supervised resistance exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Arms:
Resistance training booster group, Resistance training control group
Aerobic training booster sessions
Supervised aerobic training booster sessions delivered in the follow up period (two sessions every fifth week).
Arms:
Aerobic training booster group
Resistance training booster sessions
Supervised resistance training booster sessions in the follow up period (two sessions every fifth week).
Arms:
Resistance training booster group
Size
150
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).
Baseline,12 weeks and 52 weeks.
Eligibility criteria
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.)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-11-29

1 organization

4 products

1 indication

Organization
Aarhus University
Product
Systematic aerobic training
Indication
Multiple Sclerosis
Product
Systematic resistance training
Product
Aerobic training booster
Product
Resistance training booster