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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Healthy Controls
• Intervention / Treatment: Behavioral: Training

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Diepenbeek, Belgium, 3590
    • REVAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined exercise; 12 weeks combined exercise programme (supervised)	Behavioral: Training; Other Names: 12 weeks of high intensity interval training or combined exercise
Experimental: High intensity interval training; 12 weeks high intensity interval exercise programme (supervised)	Behavioral: Training; Other Names: 12 weeks of high intensity interval training or combined exercise
No Intervention: Control; sedentary/habitual lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin sensitivity (insulin profile)	glucose and insulin concentration measurements in blood	change from baseline to 12 weeks
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, ...	from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength of knee extensor/flexor	by means of an isokinetic dynamometer the muscle strength and endurance will be measured	change from baseline to 12 weeks
aerobic capacity	by means of a submaximal endurance test (ergometer)	change from baseline to 12 weeks
cytokine profile	measurements of blood cytokine levels	change from baseline to 12 weeks
Self-reported measures	The self-reported measures contains some questionnaires	Change from baseline to 12 weeks
body composition	Weight, body fat% and lean tissue% will be assessed by means of a DEXA scan	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Bert Op't Eijnde
• Investigators: Principal Investigator: Inez Wens, M.Sc., Reval/Biomed, Hasselt University; Study Chair: Bert Opt Eijnde, Ph.D, Reval/Biomed, Hasselt University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 30, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 3, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: insulin resistance; high intensity interval training; combined training; muscle contractile properties
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Hyperinsulinism; Multiple Sclerosis; Sclerosis; Insulin Resistance
• Other Study ID Numbers: 13.20/reva13.02