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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

NCT ID: NCT02848976

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IA group

EDSS (Expanded Disability Status Scale) below 6 with RE

Re-training to effort (RE)

Intervention Type OTHER

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

IB group

EDSS (Expanded Disability Status Scale) below 6 with no RE

No interventions assigned to this group

IIA group

EDSS (Expanded Disability Status Scale) betwin 6 and 8 with RE

Re-training to effort (RE)

Intervention Type OTHER

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

IIB group

EDSS (Expanded Disability Status Scale) below 6 with RE

Re-training to effort (RE)

Intervention Type OTHER

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

Interventions

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Re-training to effort (RE)

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

Intervention Type OTHER

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc LE FORT, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC13_0296

Identifier Type: -

Identifier Source: org_study_id