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Multiple Sclerosis and Progressive Resistance Training

Primary Purpose

Multiple Sclerosis (Relapsing Remitting)

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Training
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis (Relapsing Remitting) focused on measuring Resistance Training, Strength Training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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%.

Sites / Locations

  • MS Clinic, Department of Neurology, Aarhus University Hospital
  • Sport Science, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training

Control

Arm Description

Outcomes

Primary Outcome Measures

Blood-borne biomarkers
Resting levels of bloodbourne biomarkers; Cytokines Neurotrophins

Secondary Outcome Measures

Neuro-muscular function of knee extensors
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
Walking performance will be assessed by the; Two minute walk test 25-foot walk test Chair rise test Stair climb test
Self-reported measures
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
MRI-scans of the head will provide the following measurements; Brain volume (analysed with SIENA) Plaque incidence
Body Composition
Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)
Thigh muscle cross-sectional area
MRI-scans of the thigh will provide cross-sectional area of m. quadriceps m. hamstring

Full Information

First Posted
January 6, 2012
Last Updated
December 1, 2014
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT01518660
Brief Title
Multiple Sclerosis and Progressive Resistance Training
Official Title
Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Biogen

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (Relapsing Remitting)
Keywords
Resistance Training, Strength Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
Bi-weekly progressive resistance training
Primary Outcome Measure Information:
Title
Blood-borne biomarkers
Description
Resting levels of bloodbourne biomarkers; Cytokines Neurotrophins
Time Frame
Change from baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Neuro-muscular function of knee extensors
Description
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
Time Frame
Change from baseline to 24 weeks
Title
Walking performance
Description
Walking performance will be assessed by the; Two minute walk test 25-foot walk test Chair rise test Stair climb test
Time Frame
Change from baseline to 24 weeks
Title
Self-reported measures
Description
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)
Time Frame
Change from baseline to 24 weeks
Title
Brain volume
Description
MRI-scans of the head will provide the following measurements; Brain volume (analysed with SIENA) Plaque incidence
Time Frame
Change from baseline to 24 weeks
Title
Body Composition
Description
Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)
Time Frame
Change from baseline to 24 weeks
Title
Thigh muscle cross-sectional area
Description
MRI-scans of the thigh will provide cross-sectional area of m. quadriceps m. hamstring
Time Frame
Change from baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tue Kjølhede, M.Sc.
Organizational Affiliation
Sport Science, Department of Public Health, Aarhus University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrik Dalgas, Ph.D.
Organizational Affiliation
Sport Science, Department of Public Health, Aarhus University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristian Vissing, Ph.D.
Organizational Affiliation
Sport Science, Department of Public Health, Aarhus University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thor Petersen, Dr.med
Organizational Affiliation
MS Clinic, Department of Neurology, Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
MS Clinic, Department of Neurology, Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Sport Science, Aarhus University
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Multiple Sclerosis and Progressive Resistance Training

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