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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 (RE-SEP)

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: Re-training to effort (RE)

Study type

Observational

Funder types

Other

Identifiers

NCT02848976
RC13_0296

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

32 participants in 4 patient groups

IA group
Description:
EDSS (Expanded Disability Status Scale) below 6 with RE
Treatment:
Other: Re-training to effort (RE)
IB group
Description:
EDSS (Expanded Disability Status Scale) below 6 with no RE
IIA group
Description:
EDSS (Expanded Disability Status Scale) betwin 6 and 8 with RE
Treatment:
Other: Re-training to effort (RE)
IIB group
Description:
EDSS (Expanded Disability Status Scale) below 6 with RE
Treatment:
Other: Re-training to effort (RE)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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