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Clinical Trials/NCT02848976
NCT02848976
Completed
Not Applicable

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

Nantes University Hospital1 site in 1 country32 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Nantes University Hospital
Enrollment
32
Locations
1
Primary Endpoint
Scale impact of fatigue in MS (EMIF-SEP)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
May 2010
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Scale impact of fatigue in MS (EMIF-SEP)

Time Frame: 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

Time Frame: 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

Study Sites (1)

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