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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Exercise

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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training

one group will receive resistance training and one group the normal physiotherapeutic treatment

No interventions assigned to this group

physiotherapy

one group will receive resistance training and one group the normal physiotherapeutic treatment

No interventions assigned to this group

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No