Clinical trial NCT05533034: Personalized Home Respiratory Rehabilitation Program for Subjects with Systemic Sclerosis with Early Lung Disease
Official title: Personalized Home Respiratory Rehabilitation Program for Subjects with Systemic Sclerosis with Early Lung Disease: Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Sclerosis
Keywords: Systemic Sclerosis
Lung disease
Rehabilitation
Respiratory deficiencies
Feasibility study
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Number of lost to follow up patients
timeFrame: 3 months
measure: Number of uncompleted questionnaires
timeFrame: 3 months
measure: Amount of aerobic work recorded using a connected watch
timeFrame: 3 months
measure: Amount of exercises self-reported in a logbook
timeFrame: 3 months
measure: Exercise Adherence Rating Scale (EARS) questionnaire
timeFrame: 3 months
measure: Self-reported adherence
timeFrame: 3 months
measure: Exercise Adherence Rating Scale (EARS) questionnaire
timeFrame: 3 months
measure: Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)
timeFrame: 3 months
measure: Check-list to report side effects
timeFrame: 3 months
Secondary outcomes:
measure: Lung volume
timeFrame: Day of inclusion
measure: Lung volume
timeFrame: 3 months
measure: Diffusing capacity
timeFrame: Day of inclusion
measure: Diffusing capacity
timeFrame: 3 months
measure: Maximal oxygen consumption during a 6 minute walking test
timeFrame: Day of inclusion
measure: Maximal oxygen consumption during a 6 minute walking test
timeFrame: 3 months
measure: Saint Georges hospital questionnaire
timeFrame: Day of inclusion
measure: Saint Georges hospital questionnaire
timeFrame: 3 months
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Day of inclusion
measure: Health Assessment Questionnaire (HAQ)
timeFrame: 3 months
measure: 12-Items short form survey questionnaire (SF-12)
timeFrame: Day of inclusion
measure: 12-Items short form survey questionnaire (SF-12)
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital
state: Ile de France
Study officials:
affiliation: Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
name: Camille DASTE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
name: Christelle NGUYEN, MD, PhD
role: STUDY_DIRECTOR
References: