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

Launched by COORDINACIÓN DE INVESTIGACIÓN EN SALUD, MEXICO · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a 36-session supervised pulmonary rehabilitation program on patients with interstitial lung disease caused by systemic sclerosis, a condition that affects the lungs and can lead to serious health issues. The goal is to see how this program impacts patients' ability to use oxygen, their overall physical function, and their quality of life. Participants will undergo tests before and after the rehabilitation program to measure these effects.

To be eligible for this trial, participants must have a confirmed diagnosis of systemic sclerosis and interstitial lung disease, determined by specific medical criteria. They can be of any age and can be receiving various treatments for their condition. However, individuals who are pregnant, have certain health issues that make physical activity unsafe, or have recently had surgeries may not be able to participate. Those who join the study can expect to complete a series of tests and questionnaires to help assess their health before starting the rehabilitation program and again after completing it. This research aims to provide valuable insights into how rehabilitation can improve the lives of patients with this challenging condition.

Gender

ALL

Eligibility criteria

• 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.