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Completed

NCT Number: NCT01518660

Multiple Sclerosis and Progressive Resistance Training

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

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Key information

Conditions

Multiple Sclerosis (Relapsing Remitting) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MS Clinic, Department of Neurology, Aarhus University Hospital, Aarhus C, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Training

Behavioral

Bi-weekly progressive resistance training

Primary outcomes

  1. Blood-borne biomarkers

    Time frame: Change from baseline to 24 weeks

    Resting levels of bloodbourne biomarkers;

    • Cytokines
    • Neurotrophins

Secondary outcomes

  1. Neuro-muscular function of knee extensors

    Time frame: 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

  2. Walking performance

    Time frame: 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

  3. Self-reported measures

    Time frame: 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)

  4. Brain volume

    Time frame: Change from baseline to 24 weeks

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

    • Brain volume (analysed with SIENA)
    • Plaque incidence

  5. Body Composition

    Time frame: Change from baseline to 24 weeks

    Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)

  6. Thigh muscle cross-sectional area

    Time frame: Change from baseline to 24 weeks

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

    • m. quadriceps
    • m. hamstring

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Biogen

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2012
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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