Pulmonary rehabilitation for patients with lung disease from systemic sclerosis
"Effect of a Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis on Oxygen Consumption, Functionality, and Quality of Life"
This study is testing a 36-session rehab program to see if it helps people with lung disease from systemic sclerosis breathe better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 67 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06105073 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a 36-session supervised pulmonary rehabilitation program on patients with interstitial lung disease associated with systemic sclerosis. It aims to assess changes in oxygen consumption, functionality, and quality of life before and after the rehabilitation program using validated questionnaires and exercise tests. Participants will undergo various assessments, including spirometry and cardiopulmonary exercise tests, to gather comprehensive data on their respiratory function and overall health. The study is conducted at the National Medical Center La Raza in Mexico City, focusing on patients diagnosed with this specific condition.
Who should consider this trial
Good fit: Ideal candidates include patients with a confirmed diagnosis of systemic sclerosis and interstitial lung disease, regardless of the duration of their condition.
Not a fit: Patients who are pregnant, have severe respiratory limitations, or other contraindications to physical exertion may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and functional capacity of patients suffering from interstitial lung disease associated with systemic sclerosis.
How similar studies have performed: Other studies have shown positive outcomes with pulmonary rehabilitation in similar patient populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City
- Centro Medico Nacional La Raza — Mexico City, Mexico (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.