Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease: Pilot Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Systemic sclerosis according to ACR/EULAR 2013 criteria

• Lung involvement, with FCV \> 70% on PFT

Locations
Other Locations
France
Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital
RECRUITING
Paris
Contact Information
Primary
Alexandra ROREN, PhD
alexandra.roren@aphp.fr
00 33 1 58 41 13 71
Backup
Marie BENHAMMANI-GODARD
marie.godard@aphp.fr
0033 1 58411190
Time Frame
Start Date: 2024-04-08
Estimated Completion Date: 2026-03
Participants
Target number of participants: 15
Treatments
Experimental: Home based exercises
1 supervised session in the outpatient rehabilitation department with respiratory, aerobic and muscles strengthening exercises, followed by 3 months of self-manage personalized home exercises program. Cardiac frequency and adherence to exercise will be monitored using an activity tracker (Garmin© watch).
Related Therapeutic Areas
Sponsors
Collaborators: URC-CIC Paris Descartes Necker Cochin
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov