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

Biogen38 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Exercise

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (14)

Coordinating Research Site

NSW, Australia

Research Site

Odense, Denmark

Research Site

Sønderborg, Denmark

Research Site

Vejle, Denmark

Research Site

Jyväskylä, Finland

Research Site

Oulu, Finland

Research Site

Pori, Finland

Research Site

Seinäjokï, Finland

Research Site

Hamilton, New Zealand

Research Site

Drammen, Norway

...and 4 more locations

Outcomes

Primary Outcomes

Change of muscle strength

Measured by chair stand test

Time frame: Baseline, 12 months, 15 months and 18 months.

Secondary Outcomes

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)

Time frame: Baseline, 12 months and 18 months