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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Other: Rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

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.; Other Names: Personalized home exercises program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of lost to follow up patients	Adherence to treatment	3 months
Number of uncompleted questionnaires	Adherence to treatment	3 months
Amount of aerobic work recorded using a connected watch	Adherence to treatment / Amount of aerobic work recorded using a connected watch with heart rate monitor	3 months
Amount of exercises self-reported in a logbook	Adherence to treatment	3 months
Exercise Adherence Rating Scale (EARS) questionnaire	Adherence to treatment / Amount of exercises	3 months
Self-reported adherence	Adherence to treatment	3 months
Exercise Adherence Rating Scale (EARS) questionnaire	Adherence to treatment	3 months
Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)	Adherence to treatment / Burden of program	3 months
Check-list to report side effects	Adherence to treatment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung volume	Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months	Day of inclusion
Lung volume	Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months	3 months
Diffusing capacity	Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months	Day of inclusion
Diffusing capacity	Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months	3 months
Maximal oxygen consumption during a 6 minute walking test	Aerobic capacity / Variation between base line and 3 months	Day of inclusion
Maximal oxygen consumption during a 6 minute walking test	Aerobic capacity / Variation between base line and 3 months	3 months
Saint Georges hospital questionnaire	Activity limitations specific to respiratory function / Variation between base line and 3 months	Day of inclusion
Saint Georges hospital questionnaire	Activity limitations specific to respiratory function / Variation between base line and 3 months	3 months
Health Assessment Questionnaire (HAQ)	Overall activity limitations / Variation between base line and 3 months	Day of inclusion
Health Assessment Questionnaire (HAQ)	Overall activity limitations / Variation between base line and 3 months	3 months
12-Items short form survey questionnaire (SF-12)	Quality of life / Variation between base line and 3 months	Day of inclusion
12-Items short form survey questionnaire (SF-12)	Quality of life / Variation between base line and 3 months	3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Camille DASTE, MD, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP); Study Director: Christelle NGUYEN, MD, PhD, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Actual): April 21, 2026
• Study Completion (Actual): April 21, 2026

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Systemic Sclerosis; Feasibility study; Lung disease; Respiratory deficiencies
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Respiratory Tract Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lung Diseases; Scleroderma, Systemic; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: APHP210260; 2020-A03551-38 (Other Identifier: France : ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No