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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Training
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring combined training, insulin resistance

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 Type

Experimental

No Intervention

Arm Label

Training

Control

Arm Description

24 weeks combined exercise programme (supervised)

sedentary/habitual lifestyle

Outcomes

Primary Outcome Measures

insulin sensitivity (insulin profile)
glucose and insulin concentration measurements in blood

Secondary Outcome Measures

aerobic capacity
by means of a submaximal endurance test (ergometer)
aerobic capacity - lactate concentrations
by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)
cytokine profile
measurements of blood cytokine levels
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
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 (Dual-energy X-ray absorptiometry) scan
muscle strength of knee flexor
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
muscle strength of knee extensor
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
muscle strength of elbow flexor
by means of an isokinetic dynamometer the muscle strength will be measured
muscle strength of elbow extensor
by means of an isokinetic dynamometer the muscle strength will be measured

Full Information

First Posted
October 23, 2012
Last Updated
November 22, 2016
Sponsor
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT01718392
Brief Title
Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
combined training, insulin resistance

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Experimental
Arm Description
24 weeks combined 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)
24 weeks combined exercise programma (supervised)
Primary Outcome Measure Information:
Title
insulin sensitivity (insulin profile)
Description
glucose and insulin concentration measurements in blood
Time Frame
change from baseline to 24 weeks
Secondary Outcome Measure Information:
Title
aerobic capacity
Description
by means of a submaximal endurance test (ergometer)
Time Frame
change from baseline to 24 weeks
Title
aerobic capacity - lactate concentrations
Description
by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)
Time Frame
change from baseline to 24 weeks
Title
cytokine profile
Description
measurements of blood cytokine levels
Time Frame
change from baseline to 24 weeks
Title
walking performance
Description
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
Title
Self-reported measures
Description
The self-reported measures contains some questionnaires
Time Frame
Change from baseline to 24 weeks
Title
body composition
Description
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
Title
muscle strength of knee flexor
Description
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
Time Frame
change from baseline to 24 weeks
Title
muscle strength of knee extensor
Description
by means of an isokinetic dynamometer the muscle strength and endurance will be measured
Time Frame
change from baseline to 24 weeks
Title
muscle strength of elbow flexor
Description
by means of an isokinetic dynamometer the muscle strength will be measured
Time Frame
change from baseline to 24 weeks
Title
muscle strength of elbow extensor
Description
by means of an isokinetic dynamometer the muscle strength will be measured
Time Frame
change from baseline to 24 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 Op't 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

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

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