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

Biogen

Status

Completed

Conditions

Exercise

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT01065090

ACTIMS

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.