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

Systemic Sclerosis Clinical Trial

— SCLERESPIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533034
• Other study ID #: APHP210260
• Secondary ID: 2020-A03551-38
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Alexandra ROREN, PhD
• Phone: 00 33 1 58 41 13 71
• Email: alexandra.roren[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%

Related Conditions & MeSH terms

• Lung Diseases
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

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.

Locations

Country	Name	City	State
France	Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of lost to follow up patients	Adherence to treatment	3 months
Primary	Number of uncompleted questionnaires	Adherence to treatment	3 months
Primary	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	3 months
Primary	Amount of exercises self-reported in a logbook	Adherence to treatment	3 months
Primary	Exercise Adherence Rating Scale (EARS) questionnaire	Adherence to treatment / Amount of exercises	3 months
Primary	Self-reported adherence	Adherence to treatment	3 months
Primary	Exercise Adherence Rating Scale (EARS) questionnaire	Adherence to treatment	3 months
Primary	Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)	Adherence to treatment / Burden of program	3 months
Primary	Check-list to report side effects	Adherence to treatment	3 months
Secondary	Lung volume	Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months	Day of inclusion
Secondary	Lung volume	Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months	3 months
Secondary	Diffusing capacity	Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months	Day of inclusion
Secondary	Diffusing capacity	Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months	3 months
Secondary	Maximal oxygen consumption during a 6 minute walking test	Aerobic capacity / Variation between base line and 3 months	Day of inclusion
Secondary	Maximal oxygen consumption during a 6 minute walking test	Aerobic capacity / Variation between base line and 3 months	3 months
Secondary	Saint Georges hospital questionnaire	Activity limitations specific to respiratory function / Variation between base line and 3 months	Day of inclusion
Secondary	Saint Georges hospital questionnaire	Activity limitations specific to respiratory function / Variation between base line and 3 months	3 months
Secondary	Health Assessment Questionnaire (HAQ)	Overall activity limitations / Variation between base line and 3 months	Day of inclusion
Secondary	Health Assessment Questionnaire (HAQ)	Overall activity limitations / Variation between base line and 3 months	3 months
Secondary	12-Items short form survey questionnaire (SF-12)	Quality of life / Variation between base line and 3 months	Day of inclusion
Secondary	12-Items short form survey questionnaire (SF-12)	Quality of life / Variation between base line and 3 months	3 months