Role of Individualized Versus Traditional Exercise in Combating Fatigue (REEN-SEP)

Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients

The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: traditional training program; Other: Adapted and individualized physical training program

Detailed Description

Chronic fatigue is a very common symptom reported (80%) by patients with multiple sclerosis (MS), regardless of the type of MS and level of disability. Despite the clinical importance of MS-related fatigue, pharmacological treatments remain quite ineffective in preventing or treating chronic fatigue.

Recently, physical activity has proven to be an effective therapy with benefits on chronic fatigue as well as on different functions (muscular, cardiorespiratory, cognitive, etc.). Nevertheless, the effects of physical exercise may vary between MS patients, as MS is a heterogeneous disease and does not affect each individual in the same way. The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 to 70 years old
• Male or female
• With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010 criteria.
• Between 2 and 25 years from the onset of multiple sclerosis
• With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4 and Fatigue questionnaire > 38.
• Expanded Disability Status Scale Score 5
• Testing ≥ 4 in all leg muscles.
• Ability to walk for 10 minutes without stopping (self-reported)
• Affiliates or beneficiaries of a social security scheme
• Having freely given their written consent after having been informed of the purpose, course of action and potential risks involved

Exclusion Criteria:

• Severe cerebellar spasticity or ataxia in either leg.
• Abnormal range of motion of the toes and/or ankle.
• Musculoskeletal injury that interferes with pedaling.
• High resting heart rate (>90 beats per minute).
• Blood pressure > 144/94 mmHg.
• Onset of a multiple sclerosis attack within 90 days prior to the study.
• Recent adjustment of any medication or drugs that may impact on fatigue, or taking stimulants for fatigue (e.g. Modafinil).
• Taking of neuro-active substances that may impair cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) throughout the study period.
• Contraindication to the application of a magnetic field
• History of co-morbid disease or conditions that would compromise the subject's safety during the study.
• Participation at the same time in another medical intervention study or having participated in such a study within 30 days prior to this study.
• Pregnant and Nursing Women
• Women of childbearing age without effective contraception
• Patient unable to understand the purpose and conditions of the study, incapable of giving consent
• Patient deprived of liberty or patient under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional exercise; fatigued multiple sclerosis patients with a traditional training program	Other: traditional training program; Same training program for all patients in this group
Experimental: Individual exercise; tired multiple sclerosis patients with an adapted and individualized training program	Other: Adapted and individualized physical training program; Physical training program adapted and individualized according to each patient in this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic fatigue score	assessed using the Fatigue Severity Scale (FSS) questionnaire before and after an individualized re-training program compared to a traditional re-training program in MS patients.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiorespiratory fitness	evaluated by measuring the maximum oxygen consumption (VO2max) during an incremental exercise on a cycloergometer.	Month 3
Hematological parameters	red blood cell and hemoglobin levels measured by spectrophotometry.	Month 3
Inflammatory parameters	c-reactive protein	Month 3
quality of sleep	actigraphy measurements and sleep diary records	Month 3
cortical activation level	transcranial magnetic stimulation	Month 3
cortico-spinal excitability	transcranial magnetic stimulation	Month 3
neuromuscular fatigue of peripheral function	electrical nerve stimulation	Month 3
Analysis overall quality of life : Fatigue questionnaire	Fatigue questionnaire by Modified Fatigue Impact Scale (MFIS) results	Month 3
Analysis overall quality of life :Quality of Life	Quality of Life Questionnaire by SEP-59 results	Month 3
Analysis overall quality of life :Depression	Depression Questionnaire by Center for Epidemiologic Studies Depression (CES-D) results	Month 3
Analysis overall quality of life : Sleep Quality	Sleep Quality Questionnaire by Pittsburgh Sleep Quality Index (PSQ-I) results	Month 3
Analysis overall quality of life : Physical Activity	Physical Activity Questionnaire by Godin Leisure-Time Exercise Questionnaire (GLTEQ) results	Month 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Jean Philippe CAMDESSANCHE, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: fatigue; multiple sclerosis; individual exercise; traditional exercise
• 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; Fatigue
• Other Study ID Numbers: 20CH032; 2020-A00841-38 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No