NCT05533034Completed
Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease
Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease: Pilot Feasibility Study
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
Systematic sclerosis (SSc) is a potentially severe disease characterized by various visceral involvements including lung. The investigators hypothesize that a respiratory rehabilitation program specifically designed for people with systematic sclerosis with early lung disease could help to decrease respiratory deficiencies, improve aerobic capacity and prevent activity limitations and participation restrictions. Before testing the effectiveness of such a program, a pilot study is needed to assess its feasibility and optimize its content. Participants will have 1 supervised session in the outpatient rehabilitation department. Each patient will then perform the home personalized exercises program for 3 months. The feasibility of the program will be assessed at 3 months using patients' adherence to the program (assessed by the number of lost to follow-up, the number of questionnaires not completed, the amount of aerobic activity and the amount of home personalized exercises, treatment burden, adverse effects and quality of life.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 7 Jul 2022
- Start date
- 8 Apr 2024
- Primary completion date
- 21 Apr 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05533034
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 8 Apr 2024 to the primary completion date, 21 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Inability to understand French
- Pregnancy or breastfeeding
- Pathological EKG
- Oxygen saturation at rest or during physical activity \< 90%
- FCV \< 70%
Who the study is looking for
- Systemic sclerosis according to ACR/EULAR 2013 criteria
- Lung involvement, with FCV \> 70% on PFT
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.