Actively Recruiting
Effects of Individualized, Home-based, Mobile App-guided Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis: a Randomized Controlled Trial.
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2024-10-23
96
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system, causing a wide range of symptoms including fatigue, which is experienced by 80% of patients. This research aims to evaluate the effects of individualized home-based training, guided by a mobile app, on reducing fatigue in patients with newly and advanced diagnosed MS. The study addresses the need for better exercise therapy personalization, home practice, and early initiation to improve patient outcomes. Participants will be assigned to one of four groups based on their diagnosis stage and exercise type: newly diagnosed or advanced MS patients doing either traditional aerobic and resistance exercises at home or individualized exercises guided by a mobile app tailored to their specific disabilities. The individualized program targets muscle strength and cardiorespiratory conditioning. Training is conducted at home, with the mobile app providing guidance for the experimental groups. Throughout the study, participants will be monitored using various assessments including the Fatigue Severity Scale at week 15, muscle biopsies, muscle enzymatic activity, VO2max, strength measurements, balance tests, and questionnaires on quality of life, sleep quality, anxiety, and depression. Data collection occurs up to week 17, with the aim to measure fatigue reduction and physical improvements. The study also tracks safety and adherence over this period, ensuring a comprehensive evaluation of the exercise programs.
CONDITIONS
Brief 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...
- Adults aged 18 to 60 years
- Diagnosed with relapsing-remitting multiple sclerosis according to McDonald criteria
- MS diagnosed less than 2 years ago or first symptoms less than 5 years old, or MS diagnosed more than 2 years ago with first symptoms less than 5 years old
- High level of fatigue with Fatigue Severity Scale (FSS) score greater than 4
- Expanded Disability Status Scale (EDSS) score less than 4
- Medical Research Council (MRC) muscle strength testing at least 4 in all leg muscles
- Ability to walk for 10 minutes without stopping (self-reported)
- Have a mobile phone with internet access
- Affiliated with or benefiting from a social security scheme
- Provided written informed consent after being informed about the study
You will not qualify if you...
- Spasticity or severe cerebellar ataxia in either leg
- Abnormal range of movement of toes and/or ankle
- Musculoskeletal injury impairing pedalling
- Multiple sclerosis attack within 90 days before the study
- Recent medication changes impacting fatigue, including neuropathic pain treatments or stimulants (e.g., modafinil, amantadine, fampridine)
- History of comorbid illness compromising safety during the study
- Participation in another medical intervention study currently or within 30 days prior
- Pregnant or breastfeeding women
- Inability to understand study purpose or provide consent
- Patients deprived of liberty or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 weeks
Participants perform either traditional aerobic and resistance exercises or individualized mobile app-guided training at home targeting their specific disabilities to reduce fatigue.
Weekly visits for assessments
Duration - Up to 17 weeks from start
Participants undergo muscle biopsies, muscle strength and balance tests, and quality of life assessments to evaluate treatment effects.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 1 location
1
Chu de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
Research Team
J
Jean-Philippe CAMDESSANCHE, PHD
L
Leonard FEASSON, PHD
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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