Clinical trial NCT02848976: Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life
Official title: Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Due to the double question about the expected benefits of our CR program, the inclusion of patients was conducted in two distinct periods, from specialized MS consultations in the services of Neurology and Physical Medicine and Rehabilitation ( MPR) of the University Hospital of Nantes (France). The first period (I) would lead to compare patients with EDSS less than 6 performing an exercise training (retrained group = IA) and patients with similar levels of EDSS not engaged in physical training (not retrained group = IB). The second period (II) compared to patients EDSS between 6 and 8 (EDSS group high = IIA) and patients with lower EDSS (EDSS group IIB = low), the two groups were following a RE program.

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.


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.

Primary outcomes:
measure: SEP-59 questionnaire in MS
timeFrame: 1 month
measure: Scale impact of fatigue in MS (EMIF-SEP)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Marc LE FORT, Doctor
role: PRINCIPAL_INVESTIGATOR
References: