Actively Recruiting
Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2024-10-23
96
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Current pharmacological treatments for MS patients reduce the number of relapses and their severity but do not improve symptoms such as fatigue. Physical activity is a therapy that helps reduce this fatigue, in addition to improving muscular and cardiorespiratory functions. However, the results are not optimal because MS patients remain less active than the general population. The improvement of the benefits of exercise therapy could therefore be based on three approaches: personalization of the training program, home practice and early initiation.
CONDITIONS
Official Title
Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have relapsing-remitting multiple sclerosis (RRMS) diagnosed by McDonald criteria
- MS diagnosed less than 2 years ago or first symptoms less than 5 years ago, or diagnosed more than 2 years ago with first symptoms less than 5 years ago
- Experience high fatigue with a Fatigue Severity Scale score over 4
- Have an Expanded Disability Status Scale score less than 4
- Have muscle strength of 4 or greater in all leg muscles by Medical Research Council testing
- Be able to walk for 10 minutes without stopping (self-reported)
- Own a mobile phone with internet access
- Be affiliated with or benefit from a social security scheme
- Provide written informed consent after understanding the study's purpose and procedures
You will not qualify if you...
- Have spasticity or severe cerebellar ataxia in either leg
- Have abnormal movement range of toes or ankle
- Have musculoskeletal injury that impairs pedaling
- Experienced an MS attack within 90 days before the study
- Recently changed medications that affect fatigue, including treatments for neuropathic pain or stimulants like modafinil, amantadine, or fampridine
- Have other illnesses or conditions that could risk safety during the study
- Currently participate or recently participated in another medical intervention study within 30 days
- Are pregnant or breastfeeding
- Are unable to understand the study or provide consent
- Are deprived of liberty or under guardianship
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chu de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
Research Team
J
Jean-Philippe CAMDESSANCHE, PHD
CONTACT
L
Leonard FEASSON, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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