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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Training

• Registration Number: NCT01718392
• Lead Sponsor: Hasselt University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Primary Completion: 2013-03
• Study Completion: 2013-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training	Training	24 weeks combined exercise programme (supervised)

Primary Outcome Measures

Name	Time	Method
insulin sensitivity (insulin profile)	change from baseline to 24 weeks	glucose and insulin concentration measurements in blood

Secondary Outcome Measures

Name	Time	Method
aerobic capacity - lactate concentrations	change from baseline to 24 weeks	by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L)
walking performance	change from baseline to 24 weeks	Walking performance will be assessed by means of 2 and 6 minute walk test, 25-foot walk test, Chair rise test, Stair climb test
body composition	Change from baseline to 24 weeks	Weight, body fat% and lean tissue% will be assessed by means of a DEXA (Dual-energy X-ray absorptiometry) scan
muscle strength of knee extensor	change from baseline to 24 weeks	by means of an isokinetic dynamometer the muscle strength and endurance will be measured
cytokine profile	change from baseline to 24 weeks	measurements of blood cytokine levels
Self-reported measures	Change from baseline to 24 weeks	The self-reported measures contains some questionnaires
muscle strength of knee flexor	change from baseline to 24 weeks	by means of an isokinetic dynamometer the muscle strength and endurance will be measured
muscle strength of elbow flexor	change from baseline to 24 weeks	by means of an isokinetic dynamometer the muscle strength will be measured
muscle strength of elbow extensor	change from baseline to 24 weeks	by means of an isokinetic dynamometer the muscle strength will be measured
aerobic capacity	change from baseline to 24 weeks	by means of a submaximal endurance test (ergometer)

Trial Locations

Locations (1)

REVAL; 🇧🇪 Diepenbeek, Belgium