Status:
TERMINATED
Role of Individualized Versus Traditional Exercise in Combating Fatigue
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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 fa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04796272
Start Date
April 2 2021
End Date
June 30 2022
Last Update
November 2 2023
Active Locations (1)
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1
CHU de Saint-Etienne
Saint-Etienne, France