UnknownNot Applicable

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

Mexico67 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed diagnosis of SSc, determined by the treating rheumatology service either from the Rheumatology and/or Internal Medicine Service of the Specialty Hospital of the National Medical Center La Raza IMSS , based on the ACR/EULAR 2013 criteria for SSc. * Time of evolution of the disease indistinct. You can be treated with any of the drugs in the spectrum of autoimmune disease treatment (immunosuppressants, steroids, biologics, etc.). * Diagnosis of Interstitial Lung Disease associated with SSc, confirmed by HRCT and FVC \< 80% or TLC \< 80% or DLCO \< 80%. Exclusion Criteria: * Pregnant * Chest, abdominal pain, oral or facial pain that prevents using the mouthpiece or forced expiration. * Stress incontinence, dementia or confusion. * Who have contraindications for performing physical effort. * Oxygen dependence that does not allow its withdrawal for more than 10 minutes. * Recent surgeries less than 1 month in case of thorax and upper abdomen and less than three months in case of retina and middle ear surgery. * Belonging to vulnerable groups (homeless people, prisoners, etc.) * Failure to obtain the informed consent signature * Presence of contraindication to exercise such as muscular or orthopedic injuries. * Who have presented disease activity data that would have required a change in pharmacological treatment in a period of less than 12 weeks prior to the start of the rehabilitation program.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oxygen consumption peak

Timeframe: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks), estimated by cardiopulmonary exercise test

Quality of life health related

Timeframe: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)

Functionality

Timeframe: t will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)

Trial details

NCT IDNCT06105073

SponsorCoordinación de Investigación en Salud, Mexico

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-03-01

View on ClinicalTrials.gov More Systemic Sclerosis Associated Interstitial Lung Disease trials