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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Systemic sclerosis according to ACR/EULAR 2013 criteria - Lung involvement, with FCV \> 70% on PFT Who Should NOT Join This Trial: - 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% Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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%

Treatments Being Tested

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.

Locations (1)

Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital
Paris, Île-de-France Region, France