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