Personalized home rehabilitation program for lung issues in systemic sclerosis patients
Personalized Home Respiratory Rehabilitation Program for Subjects with Systemic Sclerosis with Early Lung Disease: Pilot Feasibility Study
NA · Assistance Publique - Hôpitaux de Paris · NCT05533034
This study is testing a personalized home exercise program for people with early lung problems due to systemic sclerosis to see if it helps them breathe better and improve their fitness.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, Ile de France) |
| Trial ID | NCT05533034 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility of a personalized home-based respiratory rehabilitation program for patients with systemic sclerosis who have early lung disease. Participants will engage in one supervised session at an outpatient rehabilitation department, followed by a three-month home exercise program tailored to their needs. The study will evaluate adherence to the program and its impact on respiratory deficiencies and overall aerobic capacity. The goal is to optimize the rehabilitation content before testing its effectiveness in a larger cohort.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with systemic sclerosis who exhibit early lung involvement and have a forced vital capacity greater than 70%.
Not a fit: Patients with severe pulmonary hypertension, significant musculoskeletal impairments, or other conditions that limit physical activity may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve respiratory function and quality of life for patients with systemic sclerosis and early lung disease.
How similar studies have performed: While the specific approach for systemic sclerosis is novel, similar rehabilitation programs for lung diseases have shown positive outcomes in other patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemic sclerosis according to ACR/EULAR 2013 criteria * Lung involvement, with FCV \> 70% on PFT Exclusion Criteria: * Inability to understand French * Pregnancy or breastfeeding * Arterial pulmonary hypertension \> 35 mmHg and unexplained dyspnoea or arterial pulmonary hypertension \> 40 mmHg * Major musculoskeletal impairment incompatible with physical activity * other pulmonary disease decreasing FCV * Pathological EKG * Oxygen saturation at rest or during physical activity \< 90% * FCV \< 70%
Where this trial is running
Paris, Ile de France
- Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital — Paris, Ile de France, France (RECRUITING)
Study contacts
- Principal investigator: Camille DASTE, MD — Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
- Study coordinator: Alexandra ROREN, PhD
- Email: alexandra.roren@aphp.fr
- Phone: 00 33 1 58 41 13 71
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.
Conditions: Systemic Sclerosis, Lung disease, Rehabilitation, Respiratory deficiencies, Feasibility study