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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845896
• Other study ID #: 13.20/reva13.02
• Status: Completed
• Phase: N/A
• First received: April 30, 2013
• Last updated: May 3, 2014
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Controls
• Insulin Resistance
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Training

Locations

Country	Name	City	State
Belgium	Reval	Diepenbeek

Sponsors (1)

Lead Sponsor	Collaborator
Bert Op't Eijnde

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity (insulin profile)	glucose and insulin concentration measurements in blood	change from baseline to 12 weeks	No
Primary	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	No
Secondary	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	No
Secondary	aerobic capacity	by means of a submaximal endurance test (ergometer)	change from baseline to 12 weeks	No
Secondary	cytokine profile	measurements of blood cytokine levels	change from baseline to 12 weeks	No
Secondary	Self-reported measures	The self-reported measures contains some questionnaires	Change from baseline to 12 weeks	No
Secondary	body composition	Weight, body fat% and lean tissue% will be assessed by means of a DEXA scan	Change from baseline to 12 weeks	No