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

Primary Purpose

Multiple Sclerosis, Healthy Controls

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Training
Sponsored by
Bert Op't Eijnde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring high intensity interval training, combined training, insulin resistance, muscle contractile properties

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Reval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Combined exercise

High intensity interval training

Control

Arm Description

12 weeks combined exercise programme (supervised)

12 weeks high intensity interval exercise programme (supervised)

sedentary/habitual lifestyle

Outcomes

Primary Outcome Measures

insulin sensitivity (insulin profile)
glucose and insulin concentration measurements in blood
muscle contractile properties
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

muscle strength of knee extensor/flexor
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
aerobic capacity
by means of a submaximal endurance test (ergometer)
cytokine profile
measurements of blood cytokine levels
Self-reported measures
The self-reported measures contains some questionnaires
body composition
Weight, body fat% and lean tissue% will be assessed by means of a DEXA scan

Full Information

First Posted
April 30, 2013
Last Updated
May 3, 2014
Sponsor
Bert Op't Eijnde
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1. Study Identification

Unique Protocol Identification Number
NCT01845896
Brief Title
Influence of High Intensity Exercise on Insulin Resistance, Muscle Contractile Properties, Aerobic Capacity and Body Composition in Multiple Sclerosis
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bert Op't Eijnde

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Healthy Controls
Keywords
high intensity interval training, combined training, insulin resistance, muscle contractile properties

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined exercise
Arm Type
Experimental
Arm Description
12 weeks combined exercise programme (supervised)
Arm Title
High intensity interval training
Arm Type
Experimental
Arm Description
12 weeks high intensity interval exercise programme (supervised)
Arm Title
Control
Arm Type
No Intervention
Arm Description
sedentary/habitual lifestyle
Intervention Type
Behavioral
Intervention Name(s)
Training
Other Intervention Name(s)
12 weeks of high intensity interval training or combined exercise
Primary Outcome Measure Information:
Title
insulin sensitivity (insulin profile)
Description
glucose and insulin concentration measurements in blood
Time Frame
change from baseline to 12 weeks
Title
muscle contractile properties
Description
measurements of cross sectional area and fiber distribution in muscle fibers of the m. vastus lateralis + measurements of enzymatic reactions, ATP, glycogen, ...
Time Frame
from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
muscle strength of knee extensor/flexor
Description
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
Time Frame
change from baseline to 12 weeks
Title
aerobic capacity
Description
by means of a submaximal endurance test (ergometer)
Time Frame
change from baseline to 12 weeks
Title
cytokine profile
Description
measurements of blood cytokine levels
Time Frame
change from baseline to 12 weeks
Title
Self-reported measures
Description
The self-reported measures contains some questionnaires
Time Frame
Change from baseline to 12 weeks
Title
body composition
Description
Weight, body fat% and lean tissue% will be assessed by means of a DEXA scan
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inez Wens, M.Sc.
Organizational Affiliation
Reval/Biomed, Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bert Opt Eijnde, Ph.D
Organizational Affiliation
Reval/Biomed, Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Reval
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
26418222
Citation
Wens I, Dalgas U, Vandenabeele F, Grevendonk L, Verboven K, Hansen D, Eijnde BO. High Intensity Exercise in Multiple Sclerosis: Effects on Muscle Contractile Characteristics and Exercise Capacity, a Randomised Controlled Trial. PLoS One. 2015 Sep 29;10(9):e0133697. doi: 10.1371/journal.pone.0133697. eCollection 2015.
Results Reference
derived
PubMed Identifier
25666356
Citation
Hansen D, Wens I, Vandenabeele F, Verboven K, Eijnde BO. Altered signaling for mitochondrial and myofibrillar biogenesis in skeletal muscles of patients with multiple sclerosis. Transl Res. 2015 Jul;166(1):70-9. doi: 10.1016/j.trsl.2015.01.006. Epub 2015 Jan 20.
Results Reference
derived
PubMed Identifier
25264868
Citation
Wens I, Dalgas U, Vandenabeele F, Krekels M, Grevendonk L, Eijnde BO. Multiple sclerosis affects skeletal muscle characteristics. PLoS One. 2014 Sep 29;9(9):e108158. doi: 10.1371/journal.pone.0108158. eCollection 2014.
Results Reference
derived

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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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