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

November 22, 2016 updated by: Bert Op't Eijnde, Hasselt University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Diepenbeek, Belgium, 3590
        • REVAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
sedentary/habitual lifestyle
Experimental: Training
24 weeks combined exercise programme (supervised)
Behavioral: Training
Other Names:
  • 24 weeks combined exercise programma (supervised)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin sensitivity (insulin profile)
Time Frame: change from baseline to 24 weeks
glucose and insulin concentration measurements in blood
change from baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aerobic capacity
Time Frame: change from baseline to 24 weeks
by means of a submaximal endurance test (ergometer)
change from baseline to 24 weeks
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)
change from baseline to 24 weeks
cytokine profile
Time Frame: change from baseline to 24 weeks
measurements of blood cytokine levels
change from baseline to 24 weeks
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
change from baseline to 24 weeks
Self-reported measures
Time Frame: Change from baseline to 24 weeks
The self-reported measures contains some questionnaires
Change from baseline to 24 weeks
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
Change from baseline to 24 weeks
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
change from baseline to 24 weeks
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
change from baseline to 24 weeks
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
change from baseline to 24 weeks
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
change from baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimate)

October 31, 2012

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CME 2011/311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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