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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Re-training to effort (RE)

• Registration Number: NCT02848976
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-29
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IIB group	Re-training to effort (RE)	EDSS (Expanded Disability Status Scale) below 6 with RE
IA group	Re-training to effort (RE)	EDSS (Expanded Disability Status Scale) below 6 with RE
IIA group	Re-training to effort (RE)	EDSS (Expanded Disability Status Scale) betwin 6 and 8 with RE

Primary Outcome Measures

Name	Time	Method
Scale impact of fatigue in MS (EMIF-SEP)	1 month	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
SEP-59 questionnaire in MS	1 month	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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France