Multiple Sclerosis and Progressive Resistance Training

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sport Science, Institute of Public Health, Aarhus University
Aarhus University Hospital
Biogen Idec
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01518660
First received: January 6, 2012
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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 Intervention
Multiple Sclerosis (Relapsing Remitting)
Behavioral: Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Blood-borne biomarkers [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]

    Resting levels of bloodbourne biomarkers;

    • Cytokines
    • Neurotrophins


Secondary Outcome Measures:
  • Neuro-muscular function of knee extensors [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]

    Walking performance will be assessed by the;

    • Two minute walk test
    • 25-foot walk test
    • Chair rise test
    • Stair climb test

  • Self-reported measures [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]

    MRI-scans of the head will provide the following measurements;

    • Brain volume (analysed with SIENA)
    • Plaque incidence

  • Body Composition [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)

  • Thigh muscle cross-sectional area [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]

    MRI-scans of the thigh will provide cross-sectional area of

    • m. quadriceps
    • m. hamstring


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training Behavioral: Training
Bi-weekly progressive resistance training
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518660

Locations
Denmark
Sport Science, Aarhus University
Aarhus C, Denmark, 8000
MS Clinic, Department of Neurology, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Sport Science, Institute of Public Health, Aarhus University
Aarhus University Hospital
Biogen Idec
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01518660     History of Changes
Other Study ID Numbers: MS&PRT_SSAU_TK
Study First Received: January 6, 2012
Last Updated: April 29, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Resistance Training
Strength Training

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014