Role of Individualized Versus Traditional Exercise in Combating Fatigue

Not Applicable

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Other: Adapted and individualized physical training program; Other: traditional training program

• Registration Number: NCT04796272
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Study Start: 2021-04-02
• Primary Completion: 2022-02-23
• Study Completion: 2022-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual exercise	Adapted and individualized physical training program	tired multiple sclerosis patients with an adapted and individualized training program
Traditional exercise	traditional training program	fatigued multiple sclerosis patients with a traditional training program

Primary Outcome Measures

Name	Time	Method
Chronic fatigue score	Month 3	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France