Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Chronic fatigue score
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
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 \>
- •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.
Outcomes
Primary Outcomes
Chronic fatigue score
Time Frame: Month 3
assessed using the Fatigue Severity Scale (FSS) questionnaire before and after an individualized re-training program compared to a traditional re-training program in MS patients.
Secondary Outcomes
- Analysis overall quality of life : Fatigue questionnaire(Month 3)
- Analysis overall quality of life : Physical Activity(Month 3)
- Hematological parameters(Month 3)
- Inflammatory parameters(Month 3)
- quality of sleep(Month 3)
- cortical activation level(Month 3)
- neuromuscular fatigue of peripheral function(Month 3)
- cortico-spinal excitability(Month 3)
- cardiorespiratory fitness(Month 3)
- Analysis overall quality of life :Quality of Life(Month 3)
- Analysis overall quality of life :Depression(Month 3)
- Analysis overall quality of life : Sleep Quality(Month 3)