Exercise
Conditions
Keywords
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
Brief summary
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.
Interventions
None listed
Sponsors
Biogen Idec A/S
Biogen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of muscle strength | Baseline, 12 months, 15 months and 18 months. | Measured by chair stand test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of speed of walking | Baseline, 12 months and 18 months | Measured by 6 min walk test, Symbol Digit Modalities Test (SDMT), Quality of Life (QoL, SF26, physical part) and Multiple Sclerosis Walking Scale (MSWS) |
Countries
Australia, Denmark, Finland, New Zealand, Norway, Sweden
Outcome results
None listed