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

NCT05533034 | Completed

• 2 other identifiers: APHP2102602020-A03551-38
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis

Keywords

Systemic Sclerosis; Lung disease; Rehabilitation; Respiratory deficiencies; Feasibility study

Outcome Measures

Primary Outcomes (9)

• Number of lost to follow up patients

  Adherence to treatment

  3 months

• Number of uncompleted questionnaires

  Adherence to treatment

  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

  3 months

• Amount of exercises self-reported in a logbook

  Adherence to treatment

  3 months

• Exercise Adherence Rating Scale (EARS) questionnaire

  Adherence to treatment / Amount of exercises

  3 months

• Self-reported adherence

  Adherence to treatment

  3 months

• Exercise Adherence Rating Scale (EARS) questionnaire

  Adherence to treatment

  3 months

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

  Adherence to treatment / Burden of program

  3 months

• Check-list to report side effects

  Adherence to treatment

  3 months

Secondary Outcomes (12)

• Lung volume

  Day of inclusion

• Lung volume

  3 months

• Diffusing capacity

  Day of inclusion

• Diffusing capacity

  3 months

• Maximal oxygen consumption during a 6 minute walking test

  Day of inclusion

Study Arms (1)

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).

Other: Rehabilitation

Interventions

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.

Also known as: Personalized home exercises program

Home based exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemic sclerosis according to ACR/EULAR 2013 criteria
• Lung involvement, with FCV \> 70% on PFT

You may not qualify if:

• 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%

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Lung Diseases

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Camille DASTE, MD

  Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

  PRINCIPAL INVESTIGATOR

• Christelle NGUYEN, MD, PhD

  Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: September 8, 2022
• Study Start: April 8, 2024
• Primary Completion: April 21, 2026
• Study Completion: April 21, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)