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

Multiple Sclerosis Clinical Trial

— RE-SEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848976
• Other study ID #: RC13_0296
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: July 26, 2016
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No