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Search / Trial NCT05533034

Personalized Home Respiratory Rehabilitation Program for Subjects with Systemic Sclerosis with Early Lung Disease

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 6, 2022

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Systemic Sclerosis Lung Disease Rehabilitation Respiratory Deficiencies Feasibility Study

ClinConnect Summary

This clinical trial is looking at a special program designed to help people with systemic sclerosis (a serious disease that can affect the lungs) who are experiencing early lung problems. The researchers believe that a personalized home exercise program can improve breathing, increase fitness levels, and help patients stay active. Before fully testing how well this program works, the team wants to first see if it’s practical and beneficial for patients.

To participate in this study, individuals should be between the ages of 65 and 74 and have been diagnosed with systemic sclerosis that meets specific criteria, along with some lung involvement. Participants will have one session with a therapist in a rehabilitation center and then follow a personalized exercise plan at home for three months. The study aims to understand how well patients stick to the program, any challenges they face, and how it affects their quality of life. It's important to note that certain conditions, like severe lung issues or other serious health problems, may exclude someone from joining the trial.

Gender

ALL

Eligibility 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%

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, Ile De France, France

Patients applied

0 patients applied

Trial Officials

Camille DASTE, MD

Principal Investigator

Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Christelle NGUYEN, MD, PhD

Study Director

Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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