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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Multiple Sclerosis, Healthy Controls

Intervention / Treatment
-----------------
* Behavioral: Training


Participation Criteria
=================
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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined exercise<br>12 weeks combined exercise programme (supervised) | Behavioral: Training<br> <br> * Other names: 12 weeks of high intensity interval training or combined exercise;|
| Experimental: High intensity interval training<br>12 weeks high intensity interval exercise programme (supervised) | Behavioral: Training<br> <br> * Other names: 12 weeks of high intensity interval training or combined exercise;|
| No Intervention: Control<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high intensity interval training, combined training, insulin resistance, muscle contractile properties