Multiple Sclerosis Clinical Trial
Official title:
Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Oxford Brookes University |
Denmark,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in physical activity, accelerometry | Measurement of level of physical activity by wearing a accelerometer for 7 days at each time point. Measured in counts/min. | Baseline, 12 weeks and 52 weeks. | |
Other | Change in aerobic capacity | Maximal oxygen uptake test on bike ergometer, measured by indirect calorimetry. | Baseline, 12 weeks and 52 weeks. | |
Other | Change in Multiple Sclerosis Walking Scale 12 (MSWS-12) | Questionnaire assessing the impact of the disease on walking. Each question is scored from 1-5 and then summed and transformed to a 0-100 scale. Higher scores indicate a greater impact on walking. | Baseline, 12 weeks and 52 weeks. | |
Other | Change in Modified Fatigue Impact Scale (MFIS) | Questionnaire assessing the effects of fatigue on physical, cognitive and psychosocial functioning. The score of the MFIS is the sum of the scores for the 21 items. A higher score represents a higher impact of fatigue, in general or in relation to one of the above mentioned areas. | Baseline, 12 weeks and 52 weeks. | |
Other | Change in Short Form Health Survey 36 (SF-36) | Questionnaire assessing health status. The SF-36 consists of eight subscales, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | Baseline, 12 weeks and 52 weeks. | |
Other | Change in Hospital anxiety and depression scale (HADS) | Questionnaire assessing anxiety and depression. It consists of two subscales (anxiety and depression), and should be scored separately. A higher score indicates a higher degree of anxiety and depression. | Baseline, 12 weeks and 52 weeks. | |
Other | Change in self reported physical activity measured by the Baecke questionnaire. | Questionnaire assessing the self reported amount of physical activity. This questionnaire quantifies the habitual physical activity level in three indexes: occupational (at work), sport (structured exercise) and leisure (leisure time). Each index is scored from 1 to 5, with 5 indicating the highest level of physical activity | Baseline, 12 weeks and 52 weeks. | |
Other | Change in maximal strength | Maximal strength measurement measured in the knee extensors by isokinetic dynamometry. | Baseline, 12 weeks and 52 weeks. | |
Primary | Change in functional capacity measured as a composite score of the six minute walk test and the 5x sit to stand test (5STS). | 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. | Baseline,12 weeks and 52 weeks. | |
Secondary | Change in functional capacity measured by the Six spot step test (SSST) | SSST is a measure of walking ability, balance and coordination. Measured as the time to complete the six-spot course. | Baseline, 12 weeks and 52 weeks. | |
Secondary | Change in functional capacity measured by the Multiple Sclerosis Functional Composite (MSFC) | Composite score from Timed 25-Feet Walk Test (T25FWT), 9-Hole Peg Test (9HPT), Paced Auditory Serial Addition Test (PASAT) | Baseline, 12 weeks and 52 weeks. |
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