Status:
UNKNOWN
"Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis"
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Systemic Sclerosis Associated Interstitial Lung Disease
Eligibility:
All Genders
18-75 years
Brief 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 rehabil...
Detailed Description
Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Interstitial Lung Disease associated Systemic Sclerosis, at the Speciality Hospital from t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06105073
Start Date
March 1 2022
End Date
March 1 2024
Last Update
February 2 2024
Active Locations (1)
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1
Centro Medico Nacional La Raza
Mexico City, Mexico, 02990