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

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ClinicalTrials.gov Identifier: NCT01845896
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Bert Op't Eijnde, Hasselt University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Healthy Controls Behavioral: Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation in MS: Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis
Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Combined exercise
12 weeks combined exercise programme (supervised)
Behavioral: Training
Other Name: 12 weeks of high intensity interval training or combined exercise

Experimental: High intensity interval training
12 weeks high intensity interval exercise programme (supervised)
Behavioral: Training
Other Name: 12 weeks of high intensity interval training or combined exercise

No Intervention: Control
sedentary/habitual lifestyle



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845896


Locations
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Belgium
Reval
Diepenbeek, Belgium, 3590
Sponsors and Collaborators
Bert Op't Eijnde
Investigators
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Principal Investigator: Inez Wens, M.Sc. Reval/Biomed, Hasselt University
Study Chair: Bert Opt Eijnde, Ph.D Reval/Biomed, Hasselt University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bert Op't Eijnde, Ph.D, Hasselt University
ClinicalTrials.gov Identifier: NCT01845896     History of Changes
Other Study ID Numbers: 13.20/reva13.02
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Bert Op't Eijnde, Hasselt University:
high intensity interval training
combined training
insulin resistance
muscle contractile properties

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Insulin Resistance
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs