Clinical trial NCT04796272: Role of Individualized Versus Traditional Exercise in Combating Fatigue
Official title: Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
individual exercise
fatigue
traditional exercise
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chronic fatigue score
timeFrame: Month 3
Secondary outcomes:
measure: cardiorespiratory fitness
timeFrame: Month 3
measure: Hematological parameters
timeFrame: Month 3
measure: Inflammatory parameters
timeFrame: Month 3
measure: quality of sleep
timeFrame: Month 3
measure: cortical activation level
timeFrame: Month 3
measure: cortico-spinal excitability
timeFrame: Month 3
measure: neuromuscular fatigue of peripheral function
timeFrame: Month 3
measure: Analysis overall quality of life : Fatigue questionnaire
timeFrame: Month 3
measure: Analysis overall quality of life :Quality of Life
timeFrame: Month 3
measure: Analysis overall quality of life :Depression
timeFrame: Month 3
measure: Analysis overall quality of life : Sleep Quality
timeFrame: Month 3
measure: Analysis overall quality of life : Physical Activity
timeFrame: Month 3
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean Philippe CAMDESSANCHE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: