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Exercise

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

Sponsored by Biogen

About this trial

Last updated 10 years ago

Study ID

ACTIMS

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 64 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 11 years ago

What is this trial 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.

What are the Participation Requirements?

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

Location

Status

For more information, view the full study details:

NCT01065090