Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life

Study Overview
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Brief Summary
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Regular physical activity promotes physical and mental well-being in the general population. Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity or because of deficiencies related to the disease, or even on the advice of their caregivers in order to save their functional abilities. Time for leisure activity could be almost 20% lower in MS patients compared to healthy controls, and this situation is likely to aggravate the functional symptoms of multiple sclerosis. The literature described the benefit of physical activity for MS patients according to protocols and varied assessments. Evaluations were indeed concern very analytical elements of metabolic functioning, nervous, muscular, cardiopulmonary etc ... or take into account the performance of components or fatigue and quality of life. Due to the multiplicity of RE protocols, sometimes on the verge of pragmatic goals of functional rehabilitation, the double issue was the profit earned by an RE program and of this benefit by level of severity of MS. The main objective of our study was an evaluation of the effects on fatigue and quality of life of a retraining program to effort suitable for levels of impairment and patients with MS activity limitations. The secondary objective was checking a performance improvement of the patients in this adapted program.

Official Title
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Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Re-training to effort (RE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients necessarily declare fatigue perceived as annoying in everyday life. Basic electrocardiogram should be absolutely normal. Patients should subject themselves to regular participation in the RE program Exclusion Criteria: In the previous month the inclusion or during the RE, the MS patients should not have presented thrust nor undergone intravenous chemotherapy, or have been in care center. Free of cognitive impairment.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IA group<br>EDSS (Expanded Disability Status Scale) below 6 with RE | Other: Re-training to effort (RE)<br>* The RE program includes three weekly sessions, supervised individually by a teacher in adapted physical activity, during 1:30, for four weeks, for a total of 12 sessions<br>|
| IB group<br>EDSS (Expanded Disability Status Scale) below 6 with no RE | |
| IIA group<br>EDSS (Expanded Disability Status Scale) betwin 6 and 8 with RE | Other: Re-training to effort (RE)<br>* The RE program includes three weekly sessions, supervised individually by a teacher in adapted physical activity, during 1:30, for four weeks, for a total of 12 sessions<br>|
| IIB group<br>EDSS (Expanded Disability Status Scale) below 6 with RE | Other: Re-training to effort (RE)<br>* The RE program includes three weekly sessions, supervised individually by a teacher in adapted physical activity, during 1:30, for four weeks, for a total of 12 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SEP-59 questionnaire in MS | The first main criteria was established by the link between the quality of life (SEP-59 self-questionnaire scores) and the specific numerical data of multiple sclerosis | 1 month | 
| Scale impact of fatigue in MS (EMIF-SEP) | The second main criteria was established by the link between the fatigue (scale impact of fatigue in MS (EMIF-SEP), self-questionnaire scores) and the specific numerical data of multiple sclerosis | 1 month |