Multiple Sclerosis and Progressive Resistance Training

Not Applicable

Completed

• Conditions: Multiple Sclerosis (Relapsing Remitting)
• Interventions: Behavioral: Training

• Registration Number: NCT01518660
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of this study is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.

Detailed Description

Exercise in general, and progressive resistance training (PRT) in particular, is regarded as an important tool in the rehabilitation of people with multiple sclerosis (MS).

Previous studies have reported positive effects of PRT on muscle strength, functional capacity, fatigue and quality of life. Also, a possible disease modifying effect has been proposed. However, the underlying physiological mechanisms that might explain these beneficial effects and the possible effects on disease progression are unresolved. Additionally, none of the previous studies has been concerned with the possible impact of MS progression type, gender and/or medication.

The purpose of this randomized, controlled, gender stratified trial is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Study Start: 2012-02
• Status Verified: 2013-04
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Diagnosed relapsing-remitting MS according to the McDonald criteria
• Expanded Disability Status Scale (EDSS) between 2.0 and 5.5
• Be able to train twice a week at the University
• Use interferon based medication

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Exclusion Criteria

• Alcohol abuse, Alzheimer's and pacemaker (or other metallic implant)
• Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
• Having had an attack in a period of 8 weeks prior to the start of the intervention period
• Having an attack during the intervention period
• Pregnancy
• Systematic resistance training in a period of 3 months prior to the start of the intervention period.
• Training adherence of less than 85%.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training	Training	-

Primary Outcome Measures

Name	Time	Method
Blood-borne biomarkers	Change from baseline to 24 weeks	Resting levels of bloodbourne biomarkers; * Cytokines; * Neurotrophins

Secondary Outcome Measures

Name	Time	Method
Brain volume	Change from baseline to 24 weeks	MRI-scans of the head will provide the following measurements; * Brain volume (analysed with SIENA); * Plaque incidence
Walking performance	Change from baseline to 24 weeks	Walking performance will be assessed by the; * Two minute walk test; * 25-foot walk test; * Chair rise test; * Stair climb test
Self-reported measures	Change from baseline to 24 weeks	The self-reported measures contains questionnaires regarding; * Fatigue (Fatigue Severity Scale, Modifies Fatigue Impact Scale); * Health-Related Quality of Life (SF-36); * Depression (Major Depression Inventory); * Disease impact (MS Impact Scale 29); * Walking Performance (MS Walking Scale 12)
Body Composition	Change from baseline to 24 weeks	Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)
Neuro-muscular function of knee extensors	Change from baseline to 24 weeks	By use of an isokinetic dynamometer, EMG and stimulation equipment the following will be assessed for the knee extensors; * Maximal muscle strength; * Surface EMG; * Central activation ratio
Thigh muscle cross-sectional area	Change from baseline to 24 weeks	MRI-scans of the thigh will provide cross-sectional area of; * m. quadriceps; * m. hamstring

Trial Locations

Locations (2)

MS Clinic, Department of Neurology, Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark

Sport Science, Aarhus University; 🇩🇰 Aarhus C, Denmark