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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Systemic Sclerosis

Treatments: Other: Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05533034

APHP210260

2020-A03551-38 (Other Identifier)

Details and patient eligibility

About

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.

Full description

SSc is responsible for a reduced life expectancy. The prognosis depends on the presence of severe visceral damage and more particularly on the presence of interstitial lung damage, pulmonary arterial hypertension or specific cardiac damage which represent the 3 main causes of mortality in SSc.

The importance of rehabilitation in SSc has been confirmed by the latest INSERM Collective Expertise 2019). The objectives of functional rehabilitation in SSc are to prevent and/or reduce the specific (cutaneous, oral, cardiorespiratory, musculoskeletal) and non-specific (exercise deconditioning, fatigue, anxiety and depression) impairments frequently characterizing the evolution of the disease. Based on the latest practice recommendations for the diagnosis and treatment of idiopathic pulmonary fibrosis, people with a confirmed diagnosis of idiopathic pulmonary fibrosis and significant exercise and activity limitations should follow a respiratory rehabilitation program.

The value of a specific respiratory rehabilitation program for people with SSc is then a matter of interest. A pilot study is needed to assess the feasibility and optimize the content of a rehabilitation program. The investigators aimed to study the feasibility of a personalized home-based respiratory rehabilitation program in people with SSc with early lung disease.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Home based exercises

Experimental group

Description:

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).

Treatment:

Other: Rehabilitation