Personalized Home Respiratory Rehabilitation Program for Subjects with Systemic Sclerosis with Early Lung Disease
- Conditions
- Systemic Sclerosis
- Interventions
- Other: Rehabilitation
- Registration Number
- NCT05533034
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- Systemic sclerosis according to ACR/EULAR 2013 criteria
- Lung involvement, with FCV > 70% on PFT
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Home based exercises Rehabilitation 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).
- Primary Outcome Measures
Name Time Method Number of lost to follow up patients 3 months Adherence to treatment
Exercise Adherence Rating Scale (EARS) questionnaire 3 months Adherence to treatment
Self-reported adherence 3 months Adherence to treatment
Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ) 3 months Adherence to treatment / Burden of program
Check-list to report side effects 3 months Adherence to treatment
Number of uncompleted questionnaires 3 months Adherence to treatment
Amount of aerobic work recorded using a connected watch 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 3 months Adherence to treatment
- Secondary Outcome Measures
Name Time Method Diffusing capacity 3 months Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Health Assessment Questionnaire (HAQ) 3 months Overall activity limitations / Variation between base line and 3 months
12-Items short form survey questionnaire (SF-12) 3 months Quality of life / Variation between base line and 3 months
Maximal oxygen consumption during a 6 minute walking test 3 months Aerobic capacity / Variation between base line and 3 months
Saint Georges hospital questionnaire 3 months Activity limitations specific to respiratory function / Variation between base line and 3 months
Lung volume 3 months Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months
Trial Locations
- Locations (1)
Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital
🇫🇷Paris, Ile de France, France