Multiple Sclerosis and Progressive Resistance Training

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01518660

Collaborator

Aarhus University Hospital (Other), Biogen (Industry)

Enrollment

Locations

Arms

Duration (Months)

17.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis (Relapsing Remitting)	Behavioral: Training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Training	Behavioral: Training Bi-weekly progressive resistance training
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Training

Behavioral: Training

Bi-weekly progressive resistance training

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Blood-borne biomarkers [Change from baseline to 24 weeks]
Resting levels of bloodbourne biomarkers; Cytokines Neurotrophins

Secondary Outcome Measures

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
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)
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
Body Composition [Change from baseline to 24 weeks]
Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MS Clinic, Department of Neurology, Aarhus University Hospital	Aarhus C		Denmark	8000
2	Sport Science, Aarhus University	Aarhus C		Denmark	8000

Sponsors and Collaborators

University of Aarhus
Aarhus University Hospital
Biogen

Investigators

Principal Investigator: Tue Kjølhede, M.Sc., Sport Science, Department of Public Health, Aarhus University
Study Chair: Ulrik Dalgas, Ph.D., Sport Science, Department of Public Health, Aarhus University
Study Chair: Kristian Vissing, Ph.D., Sport Science, Department of Public Health, Aarhus University
Study Chair: Thor Petersen, Dr.med, MS Clinic, Department of Neurology, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01518660

Other Study ID Numbers:

MS&PRT_SSAU_TK

First Posted:

Jan 26, 2012

Last Update Posted:

Dec 2, 2014

Last Verified:

Apr 1, 2013

Keywords provided by University of Aarhus

Resistance Training

Strength Training

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Dec 2, 2014