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Role of Individualized Versus Traditional Exercise in Combating Fatigue
Role of Individualized Versus Traditional Exercise in Combating Fatigue

NCT04796272

TerminatedNA

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Conditions: Multiple Sclerosis

Interventions: Adapted and individualized physical training program, traditional training program

Countries: France

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (1)
  • Saint-Etienne, France