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

Study Overview
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Brief Summary
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>24 weeks combined exercise programme (supervised) | Behavioral: Training<br> <br> * Other names: 24 weeks combined exercise programma (supervised);|
| No Intervention: Control<br>sedentary/habitual lifestyle | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity (insulin profile) | glucose and insulin concentration measurements in blood | change from baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aerobic capacity | by means of a submaximal endurance test (ergometer) | change from baseline to 24 weeks | 
| aerobic capacity - lactate concentrations | by means of a submaximal endurance test (ergometer) to determine lactate concentrations (mmol/L) | change from baseline to 24 weeks | 
| cytokine profile | measurements of blood cytokine levels | change from baseline to 24 weeks | 
| 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 | change from baseline to 24 weeks | 
| Self-reported measures | The self-reported measures contains some questionnaires | Change from baseline to 24 weeks | 
| body composition | Weight, body fat% and lean tissue% will be assessed by means of a DEXA (Dual-energy X-ray absorptiometry) scan | Change from baseline to 24 weeks | 
| muscle strength of knee flexor | by means of an isokinetic dynamometer the muscle strength and endurance will be measured | change from baseline to 24 weeks | 
| muscle strength of knee extensor | by means of an isokinetic dynamometer the muscle strength and endurance will be measured | change from baseline to 24 weeks | 
| muscle strength of elbow flexor | by means of an isokinetic dynamometer the muscle strength will be measured | change from baseline to 24 weeks | 
| muscle strength of elbow extensor | by means of an isokinetic dynamometer the muscle strength will be measured | change from baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combined training, insulin resistance