Role of Individualized Versus Traditional Exercise in Combating Fatigue
NCT ID: NCT04796272
Last Updated: 2023-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2021-04-02
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Traditional exercise
fatigued multiple sclerosis patients with a traditional training program
traditional training program
Same training program for all patients in this group
Individual exercise
tired multiple sclerosis patients with an adapted and individualized training program
Adapted and individualized physical training program
Physical training program adapted and individualized according to each patient in this group
Interventions
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Adapted and individualized physical training program
Physical training program adapted and individualized according to each patient in this group
traditional training program
Same training program for all patients in this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Jean Philippe CAMDESSANCHE, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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CHU de Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2020-A00841-38
Identifier Type: OTHER
Identifier Source: secondary_id
20CH032
Identifier Type: -
Identifier Source: org_study_id
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