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CompletedNCT01718392Updated Nov 25, 2016

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

An interventional study of Training in Multiple Sclerosis, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-25.

Sponsored by Hasselt University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • combined training
  • insulin resistance
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Training

    24 weeks combined exercise programme (supervised)

    Behavioral: Training

  • No intervention
    Control

    sedentary/habitual lifestyle

Interventions

  • BehavioralTraining

    Also known as: 24 weeks combined exercise programma (supervised)

06

What researchers measure

Primary outcomes

  1. insulin sensitivity (insulin profile)

    glucose and insulin concentration measurements in blood

    Time frame: change from baseline to 24 weeks

Secondary outcomes

  1. aerobic capacity

    by means of a submaximal endurance test (ergometer)

    Time frame: change from baseline to 24 weeks

  2. aerobic capacity - lactate concentrations

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

    Time frame: change from baseline to 24 weeks

  3. cytokine profile

    measurements of blood cytokine levels

    Time frame: change from baseline to 24 weeks

  4. walking performance

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

    Time frame: change from baseline to 24 weeks

  5. Self-reported measures

    The self-reported measures contains some questionnaires

    Time frame: Change from baseline to 24 weeks

  6. body composition

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

    Time frame: Change from baseline to 24 weeks

  7. muscle strength of knee flexor

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

    Time frame: change from baseline to 24 weeks

  8. muscle strength of knee extensor

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

    Time frame: change from baseline to 24 weeks

  9. muscle strength of elbow flexor

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

    Time frame: change from baseline to 24 weeks

  10. muscle strength of elbow extensor

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

    Time frame: change from baseline to 24 weeks

07

Study locations

1 site
  • REVAL
    Diepenbeek, 3590, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01718392
Lead sponsor
Hasselt University
Responsible party
Bert Op't Eijnde (Professor, Hasselt University) — Principal investigator
First posted
Oct 31, 2012
Start date
Mar 2011
Primary completion
Mar 2013
Completion
Sep 2013
Last update
Nov 25, 2016

Study contacts

Inez Wens, M.Sc.
principal investigator · Reval/Biomed, Hasselt University
Bert Op't Eijnde, Ph.D.
study chair · Reval/Biomed, Hasselt University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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