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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Other: traditional training program; Other: Adapted and individualized physical training program

Study type: Interventional

Funder types: Other

Identifiers

NCT04796272

2020-A00841-38 (Other Identifier)

20CH032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Traditional exercise

Active Comparator group

Description:

fatigued multiple sclerosis patients with a traditional training program

Treatment:

Other: traditional training program

Individual exercise

Experimental group

Description:

tired multiple sclerosis patients with an adapted and individualized training program

Treatment:

Other: Adapted and individualized physical training program