Combining physical activity and education for patients with chronic Lyme disease symptoms
Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis. Multicenter, Controlled, Randomized Pilot Study
This study tests whether a program that combines exercise and education can help people with chronic Lyme disease symptoms feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT05641116 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a program that integrates adapted physical activity with therapeutic education for patients suffering from chronic symptoms related to Lyme borreliosis. The intervention aims to improve patient management through a multidisciplinary approach, addressing both physical activity levels and educational support. Patients will be assessed for their symptoms and physical activity habits, and those who meet the criteria will participate in a structured program designed to enhance their overall well-being.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic Lyme disease symptoms lasting more than six months who engage in less than 150 minutes of physical activity per week.
Not a fit: Patients with significant cardiac, respiratory, or joint comorbidities that prevent safe participation in physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and functional outcomes for patients with chronic Lyme disease symptoms.
How similar studies have performed: Other studies have shown promise in using physical activity and educational interventions for chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient referred to the reference center for tick-borne diseases by his attending physician * Duration of symptoms \>6 months * At the end of the initial assessment, the diagnosis of functional somatic disorders is retained after consensus between the physicians * Patient practicing less than 150 minutes of regular physical activity per week (WHO recommendations) Exclusion Criteria: * Patients with cardiac or respiratory pathologies that contraindicate the practice of physical activity physical activity * Important comorbidities contraindicating the practice of physical activity: associated cardiac pathologies associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies respiratory pathologies (obstructive or severe restrictive respiratory insufficiency), disabling joint pathologies joint pathologies (gonarthrosis or coxarthrosis limiting training on a treadmill or on a high-intensity bicycle). intensity cycling). * Patients under guardianship or curatorship
Where this trial is running
Clermont-Ferrand and 1 other locations
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- Chu Saint Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: David HUPIN, MD — CHU de Saint Etienne
- Study coordinator: David HUPIN, MD
- 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.