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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Re-training to effort (RE)

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Marc LE FORT, Doctor, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: RC13_0296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO