A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis

Study Overview
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Brief Summary
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The primary objective of the investigation is to determine whether the addition of exercise (resistance training or modified physiotherapy) improves functional capacity in Multiple Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity without increasing the risk of relapses in participants undergoing standard DMT treatment. The secondary objectives are to determine whether exercise (resistance training or physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing DMT treatment. Also as a secondary objective, the study aims at determining whether exercise (resistance training or modified physiotherapy) has an impact on Expanded Disability Status Scale (EDSS), time to first relapse, number of relapse free participants, and immunological factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood and QoL and that an impact on immunological factors will be seen in participants even though they are undergoing standard DMT treatment.

Official Title
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A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis

Conditions
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Exercise

Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Age > 18 years and age < 65 years at screening Relapsing Remitting Multiple Sclerosis (RRMS) diagnosis according to McDonald Criteria Subjects who have been on Avonex treatment for 3-6 months prior to screening A signed informed consent form (ICF) is obtained before any study activity EDSS > 1.5 and < 5 at Screening with at least a score of 1 in pyramidal function Are able to walk at least 100 meters Are able to transport themselves to and from the training facility Key Exclusion Criteria: Suffer from dementia, alcoholism or if they use pacemaker Have any serious medical co-morbidities like cardiovascular, respiratory, orthopedic or metabolic diseases Have had a MS relapse within an eight week period prior to the study start Are pregnant Have trained systematic resistance training for one day or more each week in the prior 3 months before study start. Only able to participate in less than 70% of the planned training sessions. Suffers from major depression NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| training<br>one group will receive resistance training and one group the normal physiotherapeutic treatment | |
| physiotherapy<br>one group will receive resistance training and one group the normal physiotherapeutic treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle strength | Measured by chair stand test | Baseline, 12 months, 15 months and 18 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of speed of walking | Measured by 6 min walk test, Symbol Digit Modalities Test (SDMT), Quality of Life (QoL, SF26, physical part) and Multiple Sclerosis Walking Scale (MSWS) | Baseline, 12 months and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capacity for Work Questionnaire, exercise, AVONEX, SDMT: Symbol Digit Modalities Test, FSMC: Fatigue Scale for Motor and Cognitive functions, effects of exercise, EDSS: Expanded Disability Status Scale