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

Completed

• Conditions: Exercise

• Registration Number: NCT01065090
• Lead Sponsor: Biogen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Study Start: 2010-06
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of muscle strength	Baseline, 12 months, 15 months and 18 months.	Measured by chair stand test

Secondary Outcome Measures

Name	Time	Method
Changes of speed of walking	Baseline, 12 months and 18 months	Measured by 6 min walk test, Symbol Digit Modalities Test (SDMT), Quality of Life (QoL, SF26, physical part) and Multiple Sclerosis Walking Scale (MSWS)

Trial Locations

Locations (2)

Coordinating Research Site; 🇦🇺 NSW, Australia

Research Site; 🇸🇪 Ängelholm, Sweden