Cardiovascular Fitness of Patients With Multiple Sclerosis, Effect of Exercise on Fatigue and Depression

Study Overview
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Brief Summary
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This study is focused on patients with multiple sclerosis (MS), their cardiovascular fitness, and the effect of combined controlled training on the perception of fatigue, the development of depression, and quality of life in the first year after diagnosis.

Detailed Description
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The main goal is to find out if fatigue, depression, and quality of life depend on the type of training as well as controlled management of newly diagnosed patients. Fatigue is one of the frequent disabling symptoms and the most difficult to influence pharmacologically. It could lead to inactivity and the progression of deconditioning. We know from systematic reviews that aerobic activity leads to improvement in fatigue, however, there are also opinions about exercise intolerance due to disruption of cardiac autonomy control. The investigators will try to determine whether early rehabilitation intervention leads to support and motivation of patients with an incurable chronic neurodegenerative disease to improve the patient condition and contentment. The researchers will focus on effective training by comparing the study group with a control group of patients undergoing conventional rehabilitation versus a protocol-defined controlled combined (aerobic-resistant) exercise program - based on the results of spiroergometry. Both groups will be treated at ambulatory sections by protocol-defined rehabilitation for a 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total). The control group will be educated in exercises according to kinesiological analysis to do regularly at home. Finally, the researchers will see if early intervention leads to a change in the active approach of probands.

Official Title
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Cardiovascular Fitness and the Influence of a Controlled Combined Exercise Program on Fatigue and Depression of Newly Diagnosed Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Procedure: Controlled combined exercise group
* Procedure: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 - 45 years Newly diagnosed patients with multiple sclerosis Relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS) EDSS 0-6 Signed informed consent Exclusion Criteria: Progressive forms of MS (PRMS or SPMS), Malignant MS Non-cooperation, disagreement with the study Contraindication to spiroergometry

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study subjects will be enrolled into two parallel groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Controlled combined program (aerobic-resistant)<br>Patients randomized into the Experimental arm will undergo controlled exercise on a cycling ergometer in combination with strength training on a multifunctional fitness device for 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total). | Procedure: Controlled combined exercise group<br>* Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device<br>|
| Active Comparator: Conventional rehabilitation<br>Patients randomized into this study arm will undergo conventional rehabilitation. | Procedure: Conventional rehabilitation<br>* Patients will undergo conventional rehabilitation.<br>|
| No Intervention: No intervention<br>Patients randomized into this study arm will undergo no intervention and will serve as the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal aerobic capacity (VO2max.kg-1) | Change after six months follow up in conventional, experimental and control group | 6 months | 
| Power to weight ratio (W.kg-1) | Change after six months follow up in conventional, experimental and control group | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fatigue Impact Scale (MFIS) | Self-reported measure of level of fatigue, minimum 0 points, maximum 84 points - the less score means less fatigue | 6 months | 
| Symptom-Checklist-90-Standard (SCL-90-S) | Change in result of percentile score | 6 months | 
| Beck Depression Inventory Score II (BDI II) | Self-reported rating inventory that measures characteristic attitudes and symptoms of depression, 0-13 - minimal or none depression, 29-63 - severe depression | 6 months | 
| 36-Item Short Form Survey (SF-36) | Self-reported measure of health-related quality of life, minimum 0 points, maximum 100 points - the higher score is the sign of better quality of life | 6 months | 
| Maximal heart rate (bpm) | Change after six months follow up in conventional, experimental and control group | 6 months | 
| Heart rate variability (ms) | Change after six months follow up in conventional, experimental and control group | 6 months | 
| Body composition analysis %) | Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Controlled combined exercise, Cardiovascular fitness, Fatigue, Depression