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"Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis"

NCT06105073 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2024-02-02

No results posted yet for this study

Summary

Interstitial Lung Disease associated with Systemic Sclerosis currently represents the main cause of death in this disease, it is also the cause of significant morbidity, which is why pulmonary rehabilitation strategies can be of great benefit in this group of patients. The aim of this study is to determine the effect of a 36-session supervised pulmonary rehabilitation program compared before and after, on oxygen consumption, functionality, and quality of life in Interstitial Lung

The main question it aims to answer are:

What effect will have with a 36-session supervised pulmonary rehabilitation program, compared before and after, on oxygen consumption, functionality and quality of life in Interstitial Lung Disease associated with Systemic Sclerosis, estimated by Cardiopulmonary Exercise Test, the questionnaire self-administered SySQ (systemic sclerosis functionality questionnaire) and the self-administered questionnaire SF-36.

Disease associated with Systemic Sclerosis. Study design: Quasi-experimental, longitudinal, comparative before and after study. Methods: Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Systemic Sclerosis, at the Speciality Hospital of the National Medical Center La raza IMSS (Mexican Institute of Social Security), all those patients who wish to participate in the study will be asked to sign the informed consent letter, subsequently the Goldberg anxiety and depression questionnaire will be applied, as well as the SF-36 questionnaire to evaluate quality of life and SySQ to evaluate functionality, all participants will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test, the Pulmonary Function laboratory of the General Hospital National Medical Center La Raza IMSS . Subsequently, they will be sent to the Pulmonary Rehabilitation service, where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions (12 weeks). After the end of the program, respiratory function tests and tests will be performed again questionnaires, pulmonary function tests and cardiopulmonary exercise test.

Conditions

  • Systemic Sclerosis Associated Interstitial Lung Disease

Interventions

PROCEDURE

Pulmonary Rehabilitation Program

Consecutive patients who attend with a confirmed diagnosis of Systemic Sclerosis associated Interstitial Lung disease, at the Speciality Hospital from the Medical Center La Raza IMSS. The anxiety and depression questionnaire will be applied to them. Goldberg, as well as the SF-36 questionnaire to evaluate quality of life and the SySQ questionnaire to evaluate functionality, to include these data in the analysis, these questionnaires are validated in our population and have been widely used. All participants (T0) will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test. Then they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions, which is equivalent to 12 weeks. At the end of this period (T1), again the respiratory function tests (spirometry, DLCO and Cardiopulmonary Exercise Test) as well as the Goldberg, SF-36 and SySq questionnaires.

Sponsors & Collaborators

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-03-01
Completion
2024-03-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105073 on ClinicalTrials.gov