An interventional study of Rehabilitation in Systemic Sclerosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 15 is below the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.
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Exclusion Criteria:
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.
Also known as: Personalized home exercises program
Number of lost to follow up patients
Adherence to treatment
Time frame: 3 months
Number of uncompleted questionnaires
Adherence to treatment
Time frame: 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
Time frame: 3 months
Amount of exercises self-reported in a logbook
Adherence to treatment
Time frame: 3 months
Exercise Adherence Rating Scale (EARS) questionnaire
Adherence to treatment / Amount of exercises
Time frame: 3 months
Self-reported adherence
Adherence to treatment
Time frame: 3 months
Exercise Adherence Rating Scale (EARS) questionnaire
Adherence to treatment
Time frame: 3 months
Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)
Adherence to treatment / Burden of program
Time frame: 3 months
Check-list to report side effects
Adherence to treatment
Time frame: 3 months
Lung volume
Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Time frame: Day of inclusion
Lung volume
Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Time frame: 3 months
Diffusing capacity
Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Time frame: Day of inclusion
Diffusing capacity
Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Time frame: 3 months
Maximal oxygen consumption during a 6 minute walking test
Aerobic capacity / Variation between base line and 3 months
Time frame: Day of inclusion
Maximal oxygen consumption during a 6 minute walking test
Aerobic capacity / Variation between base line and 3 months
Time frame: 3 months
Saint Georges hospital questionnaire
Activity limitations specific to respiratory function / Variation between base line and 3 months
Time frame: Day of inclusion
Saint Georges hospital questionnaire
Activity limitations specific to respiratory function / Variation between base line and 3 months
Time frame: 3 months
Health Assessment Questionnaire (HAQ)
Overall activity limitations / Variation between base line and 3 months
Time frame: Day of inclusion
Health Assessment Questionnaire (HAQ)
Overall activity limitations / Variation between base line and 3 months
Time frame: 3 months
12-Items short form survey questionnaire (SF-12)
Quality of life / Variation between base line and 3 months
Time frame: Day of inclusion
12-Items short form survey questionnaire (SF-12)
Quality of life / Variation between base line and 3 months
Time frame: 3 months
Plan to share: Undecided
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris