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Completed

NCT Number: NCT05533034

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

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Lung Diseases Respiratory Tract Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, Île-de-France Region, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

rehabilitation

Other
  • 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

Primary outcomes

  1. Number of lost to follow up patients

    Time frame: 3 months

    Adherence to treatment

  2. Number of uncompleted questionnaires

    Time frame: 3 months

    Adherence to treatment

  3. 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

  4. Amount of exercises self-reported in a logbook

    Time frame: 3 months

    Adherence to treatment

  5. Exercise Adherence Rating Scale (EARS) questionnaire

    Time frame: 3 months

    Adherence to treatment / Amount of exercises

  6. Self-reported adherence

    Time frame: 3 months

    Adherence to treatment

  7. Exercise Adherence Rating Scale (EARS) questionnaire

    Time frame: 3 months

    Adherence to treatment

  8. Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)

    Time frame: 3 months

    Adherence to treatment / Burden of program

  9. Check-list to report side effects

    Time frame: 3 months

    Adherence to treatment

Secondary outcomes

  1. Lung volume

    Time frame: Day of inclusion

    Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months

  2. Lung volume

    Time frame: 3 months

    Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months

  3. Diffusing capacity

    Time frame: Day of inclusion

    Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months

  4. Diffusing capacity

    Time frame: 3 months

    Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months

  5. Maximal oxygen consumption during a 6 minute walking test

    Time frame: Day of inclusion

    Aerobic capacity / Variation between base line and 3 months

  6. Maximal oxygen consumption during a 6 minute walking test

    Time frame: 3 months

    Aerobic capacity / Variation between base line and 3 months

  7. Saint Georges hospital questionnaire

    Time frame: Day of inclusion

    Activity limitations specific to respiratory function / Variation between base line and 3 months

  8. Saint Georges hospital questionnaire

    Time frame: 3 months

    Activity limitations specific to respiratory function / Variation between base line and 3 months

  9. Health Assessment Questionnaire (HAQ)

    Time frame: Day of inclusion

    Overall activity limitations / Variation between base line and 3 months

  10. Health Assessment Questionnaire (HAQ)

    Time frame: 3 months

    Overall activity limitations / Variation between base line and 3 months

  11. 12-Items short form survey questionnaire (SF-12)

    Time frame: Day of inclusion

    Quality of life / Variation between base line and 3 months

  12. 12-Items short form survey questionnaire (SF-12)

    Time frame: 3 months

    Quality of life / Variation between base line and 3 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: SCLERESPIR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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