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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bert Op't Eijnde, Hasselt University
ClinicalTrials.gov Identifier:
NCT01718392
First received: October 23, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention
Multiple Sclerosis
 Behavioral: Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hasselt University:

Primary Outcome Measures:
  • insulin sensitivity (insulin profile) [ Time Frame: change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    glucose and insulin concentration measurements in blood


Secondary Outcome Measures:
  • aerobic capacity [ Time Frame: change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    by means of a submaximal endurance test (ergometer)

  • cytokine profile [ Time Frame: change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    measurements of blood cytokine levels

  • walking performance [ Time Frame: change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    Walking performance will be assessed by means of 2 and 6 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 some questionnaires

  • body composition [ Time Frame: Change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    Weight, body fat% and lean tissue% will be assessed by means of a DEXA (Dual-energy X-ray absorptiometry) scan

  • muscle strength of knee flexor [ Time Frame: change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    by means of an isokinetic dynamometer the muscle strength and endurance will be measured

  • muscle strength of knee extensor [ Time Frame: change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    by means of an isokinetic dynamometer the muscle strength and endurance will be measured

  • muscle strength of elbow flexor [ Time Frame: change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    by means of an isokinetic dynamometer the muscle strength will be measured

  • muscle strength of elbow extensor [ Time Frame: change from baseline to 24 weeks ] [ Designated as safety issue: No ]
    by means of an isokinetic dynamometer the muscle strength will be measured


Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training
24 weeks combined exercise programme (supervised)
 Behavioral: Training
Other Name: 24 weeks combined exercise programma (supervised)
No Intervention: Control
sedentary/habitual lifestyle

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718392

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

No publications provided

Responsible Party: Bert Op't Eijnde, Professor, Hasselt University
ClinicalTrials.gov Identifier: NCT01718392     History of Changes
Other Study ID Numbers: CME 2011/311
Study First Received: October 23, 2012
Last Updated: April 30, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Hasselt University:
combined training
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Multiple Sclerosis
Sclerosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
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 May 23, 2013