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OpenTrials
Completed

NCT Number: NCT01845896

Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis

The purpose of this study is to investigate the effects of a combined training programme and a high intensity interval training programme on insulin resistance, muscle strength/ muscle contractile properties, aerobic capacity and body composition in MS patients.

It is assumed that the the above mentioned clinical parameters will improve due to physical exercise.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Glucose Metabolism Disorders Healthy Controls Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reval

Diepenbeek, 3590, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosed MS according to the McDonald criteria
  • Expanded Disability Status Scale (EDSS) between 0.5 and 6
  • Be able to train 5 times in 2 weeks at the University

Exclusion criteria

  • Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases (like diabetes type 2)
  • Having had an relapse in a period of 3 months prior to the start of the intervention period
  • Having an relapse during the intervention period
  • Pregnancy and other contra indications for physical activity
  • Mental disorders

Treatment and study plan

Training

Behavioral

Other names: 12 weeks of high intensity interval training or combined exercise

Primary outcomes

  1. insulin sensitivity (insulin profile)

    Time frame: change from baseline to 12 weeks

    glucose and insulin concentration measurements in blood

  2. muscle contractile properties

    Time frame: from baseline to 12 weeks

    measurements of cross sectional area and fiber distribution in muscle fibers of the m. vastus lateralis + measurements of enzymatic reactions, ATP, glycogen, ...

Secondary outcomes

  1. muscle strength of knee extensor/flexor

    Time frame: change from baseline to 12 weeks

    by means of an isokinetic dynamometer the muscle strength and endurance will be measured

  2. aerobic capacity

    Time frame: change from baseline to 12 weeks

    by means of a submaximal endurance test (ergometer)

  3. cytokine profile

    Time frame: change from baseline to 12 weeks

    measurements of blood cytokine levels

  4. Self-reported measures

    Time frame: Change from baseline to 12 weeks

    The self-reported measures contains some questionnaires

  5. body composition

    Time frame: Change from baseline to 12 weeks

    Weight, body fat% and lean tissue% will be assessed by means of a DEXA scan

Sponsors and collaborators

Lead sponsor

Bert Op't Eijnde

Other

Registry information

Official study title

Rehabilitation in MS: Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 3, 2013
Registry last updated
May 6, 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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