Systemic SclerosisSCLERESPIRNCT05533034
Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease
A study testing Rehabilitation in people with Systemic Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2024to 21 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemic sclerosis according to ACR/EULAR 2013 criteria
- Lung involvement, with FCV > 70% on PFT
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital
Paris, Île-de-France Region, 75014
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- Rehabilitation
- Keywords
- Systemic Sclerosis, Lung disease, Rehabilitation, Respiratory deficiencies, Feasibility study
- Medical subject headings
- Scleroderma, Systemic, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Also called Personalized home exercises program
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Home based exercises | Experimental | 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). Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lost to follow up patients
Adherence to treatment
Measured: 3 months
Number of uncompleted questionnaires
Adherence to treatment
Measured: 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
Measured: 3 months
Amount of exercises self-reported in a logbook
Adherence to treatment
Measured: 3 months
Exercise Adherence Rating Scale (EARS) questionnaire
Adherence to treatment / Amount of exercises
Measured: 3 months
Self-reported adherence
Adherence to treatment
Measured: 3 months
Exercise Adherence Rating Scale (EARS) questionnaire
Adherence to treatment
Measured: 3 months
Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)
Adherence to treatment / Burden of program
Measured: 3 months
Check-list to report side effects
Adherence to treatment
Measured: 3 months
Secondary outcomes (12)
Lung volume
Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Measured: Day of inclusion
Lung volume
Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Measured: 3 months
Diffusing capacity
Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Measured: Day of inclusion
Diffusing capacity
Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Measured: 3 months
Maximal oxygen consumption during a 6 minute walking test
Aerobic capacity / Variation between base line and 3 months
Measured: Day of inclusion
Maximal oxygen consumption during a 6 minute walking test
Aerobic capacity / Variation between base line and 3 months
Measured: 3 months
Saint Georges hospital questionnaire
Activity limitations specific to respiratory function / Variation between base line and 3 months
Measured: Day of inclusion
Saint Georges hospital questionnaire
Activity limitations specific to respiratory function / Variation between base line and 3 months
Measured: 3 months
Health Assessment Questionnaire (HAQ)
Overall activity limitations / Variation between base line and 3 months
Measured: Day of inclusion
Health Assessment Questionnaire (HAQ)
Overall activity limitations / Variation between base line and 3 months
Measured: 3 months
12-Items short form survey questionnaire (SF-12)
Quality of life / Variation between base line and 3 months
Measured: Day of inclusion
12-Items short form survey questionnaire (SF-12)
Quality of life / Variation between base line and 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start8 Apr 2024
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Camille DASTE, MD, Principal investigator, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)Christelle NGUYEN, MD, PhD, Study director, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533034
- Sponsor's protocol ID
- APHP210260
- Other IDs
- 2020-A03551-38
- Acronym
- SCLERESPIR
- Status last verified
- Apr 2026
- First submitted
- 7 Jul 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease: Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05533034
- Acronym / sponsor ID
- SCLERESPIR / APHP210260
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic Sclerosis, Lung disease, Rehabilitation, Respiratory deficiencies, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home based exercises | Experimental | Other: Rehabilitation1 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systemic sclerosis according to ACR/EULAR 2013 criteria
- Lung involvement, with FCV > 70% on PFT
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationAlso: Personalized home exercises program* 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 | Home based exercises |
Primary outcome
Number of lost to follow up patients
Time frame: 3 months
Adherence to treatment
Number of uncompleted questionnaires
Time frame: 3 months
Adherence to treatment
Amount of aerobic work recorded using a connected watch
Time frame: 3 months
Adherence to treatment / Amount of aerobic work recorded using a connected watch with heart rate monitor
Amount of exercises self-reported in a logbook
Time frame: 3 months
Adherence to treatment
Exercise Adherence Rating Scale (EARS) questionnaire
Time frame: 3 months
Adherence to treatment / Amount of exercises
Self-reported adherence
Time frame: 3 months
Adherence to treatment
Exercise Adherence Rating Scale (EARS) questionnaire
Time frame: 3 months
Adherence to treatment
Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)
Time frame: 3 months
Adherence to treatment / Burden of program
Check-list to report side effects
Time frame: 3 months
Adherence to treatment
12 secondary outcomes
Lung volume
Time frame: Day of inclusion
Lung volume
Time frame: 3 months
Diffusing capacity
Time frame: Day of inclusion
Diffusing capacity
Time frame: 3 months
Maximal oxygen consumption during a 6 minute walking test
Time frame: Day of inclusion
Maximal oxygen consumption during a 6 minute walking test
Time frame: 3 months
Saint Georges hospital questionnaire
Time frame: Day of inclusion
Saint Georges hospital questionnaire
Time frame: 3 months
Health Assessment Questionnaire (HAQ)
Time frame: Day of inclusion
Health Assessment Questionnaire (HAQ)
Time frame: 3 months
12-Items short form survey questionnaire (SF-12)
Time frame: Day of inclusion
12-Items short form survey questionnaire (SF-12)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille DASTE, MD principal investigator
Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
Christelle NGUYEN, MD, PhD study director
Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Systemic Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lost to follow up patients (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.