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Completed

NCT Number: NCT01718392

Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity

the purpose of this study is to investigate the development of insulin resistance in multiple sclerosis patients + explaining the effects of a combined training programme on insulin resistance, muscle power and aerobic capacity in multiple sclerosis patients

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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 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: 24 weeks combined exercise programma (supervised)

Primary outcomes

  1. insulin sensitivity (insulin profile)

    Time frame: change from baseline to 24 weeks

    glucose and insulin concentration measurements in blood

Secondary outcomes

  1. aerobic capacity

    Time frame: change from baseline to 24 weeks

    by means of a submaximal endurance test (ergometer)

  2. aerobic capacity - lactate concentrations

    Time frame: change from baseline to 24 weeks

    by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)

  3. cytokine profile

    Time frame: change from baseline to 24 weeks

    measurements of blood cytokine levels

  4. walking performance

    Time frame: change from baseline to 24 weeks

    Walking performance will be assessed by means of 2 and 6 minute walk test, 25-foot walk test, Chair rise test, Stair climb test

  5. Self-reported measures

    Time frame: Change from baseline to 24 weeks

    The self-reported measures contains some questionnaires

  6. body composition

    Time frame: Change from baseline to 24 weeks

    Weight, body fat% and lean tissue% will be assessed by means of a DEXA (Dual-energy X-ray absorptiometry) scan

  7. muscle strength of knee flexor

    Time frame: change from baseline to 24 weeks

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

  8. muscle strength of knee extensor

    Time frame: change from baseline to 24 weeks

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

  9. muscle strength of elbow flexor

    Time frame: change from baseline to 24 weeks

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

  10. muscle strength of elbow extensor

    Time frame: change from baseline to 24 weeks

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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 31, 2012
Registry last updated
Nov 25, 2016

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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