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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)

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ClinicalTrials.gov Identifier: NCT02848976
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment
Multiple Sclerosis Other: Re-training to effort (RE)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life
Study Start Date : January 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IA group
EDSS (Expanded Disability Status Scale) below 6 with RE
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

IB group
EDSS (Expanded Disability Status Scale) below 6 with no RE
IIA group
EDSS (Expanded Disability Status Scale) betwin 6 and 8 with RE
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

IIB group
EDSS (Expanded Disability Status Scale) below 6 with RE
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




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848976


Locations
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France
University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Marc LE FORT, Doctor Nantes University Hospital

Additional Information:

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02848976     History of Changes
Other Study ID Numbers: RC13_0296
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms