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

NCT05533034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Rehabilitation

* 1 supervised session of rehabilitation, including a cardiac stress test (to define maximal intensity for aerobic activities), aerobic activity with interval training of moderate and progressive intensity (walking), and respiratory exercise using a volumetric spirometer, and strengthening exercises for lower and upper limbs. * 3 months of self-managed home exercises. Patients will be asked to use a tracker activity when performing home exercises to self-monitor cardiac frequency and to assess their adherence.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Camille DASTE, MD · Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

  • Christelle NGUYEN, MD, PhD · Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2026-04-21
Completion
2026-04-21

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05533034 on ClinicalTrials.gov