Optimized care organization for fibromyalgia patients
Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary
This study tests if a special program that includes supervised exercise and education can help people with fibromyalgia feel better compared to regular home-based care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 7 sites (Annonay and 6 other locations) |
| Trial ID | NCT04107948 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a healthcare organization designed for fibromyalgia patients, combining supervised physical activity and therapeutic education sessions. Patients will participate in a structured program that begins with a month of hospital-based physical activity followed by two months of community-based activity. The study aims to determine whether this approach is more effective than standard care, which includes home-based physical activity and education. The goal is to improve patient outcomes by addressing the challenges of inactivity and deconditioning associated with fibromyalgia.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with fibromyalgia who are sedentary or engage in low levels of physical activity.
Not a fit: Patients with significant co-morbidities that prevent them from safely participating in physical activity will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for fibromyalgia patients by enhancing their physical activity levels and reducing symptoms.
How similar studies have performed: Previous studies have shown that supervised physical activity can be beneficial for fibromyalgia patients, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13 * French writing and speaking * Sedentary or low level of activity (less than 150 minutes of regular physical activity per week at the time of inclusion) * Signature of informed consent Exclusion Criteria: * Cardiac or respiratory diseases that contraindicate the practice of physical activity * Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike). * Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason
Where this trial is running
Annonay and 6 other locations
- CH d'ANNONAY — Annonay, France (Recruiting)
- CH de Firminy — Firminy, France (Recruiting)
- CH de MONTBRISON — Montbrison, France (Recruiting)
- CH de Rive de Gier — Rive-de-Gier, France (Not_yet_recruiting)
- CH de ROANNE — Roanne, France (Recruiting)
- CH du Gier — Saint Chamond, France (Recruiting)
- Chu Saint Etienne — Saint Etienne, France (Recruiting)
Study contacts
- Principal investigator: David HUPIN — CHU de Saint Etienne
- Study coordinator: David HUPIN
- Email: David.Hupin@chu-st-etienne.fr
- Phone: 0477828413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.