Multiple Sclerosis and Progressive Resistance Training

NCT ID: NCT01518660

Last Updated: 2014-12-02

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

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis (Relapsing Remitting)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Training

Group Type EXPERIMENTAL

Training

Intervention Type BEHAVIORAL

Bi-weekly progressive resistance training

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Training

Bi-weekly progressive resistance training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Biogen

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tue Kjølhede, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Sport Science, Department of Public Health, Aarhus University

Ulrik Dalgas, Ph.D.

Role: STUDY_CHAIR

Sport Science, Department of Public Health, Aarhus University

Kristian Vissing, Ph.D.

Role: STUDY_CHAIR

Sport Science, Department of Public Health, Aarhus University

Thor Petersen, Dr.med

Role: STUDY_CHAIR

MS Clinic, Department of Neurology, Aarhus University Hospital

Locations

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MS Clinic, Department of Neurology, Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Sport Science, Aarhus University

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MS&PRT_SSAU_TK

Identifier Type: -

Identifier Source: org_study_id