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NCT06105073
"Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis"
trial testing Pulmonary Rehabilitation Program in Systemic Sclerosis Associated Interstitial Lung Disease in 67 participants. Status unknown.
1 March 2023
Quick facts
| Lead sponsor | Coordinación de Investigación en Salud, Mexico |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 67 |
| Start date | 1 March 2022 |
| Primary completion | 1 March 2023 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Pulmonary Rehabilitation Program
Conditions studied
- Systemic Sclerosis Associated Interstitial Lung Disease — all drugs for Systemic Sclerosis Associated Interstitial Lung Disease →
Sponsor
Coordinación de Investigación en Salud, Mexico — full company profile →
Who can join
Adults 18 to 75, any sex, with Systemic Sclerosis Associated Interstitial Lung Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06105073
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Pulmonary Rehabilitation Program
Trials testing the same drug.
- NCT05242094 — Pulmonary Rehabilitation Implemented With VR for Post-COVID-19 Patients · NA · unknown
Other recruiting trials for Systemic Sclerosis Associated Interstitial Lung Disease
Currently open trials in the same condition.
- NCT07080125 — A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung · active not recruiting
- NCT06189495 — A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, a · Phase 2 · recruiting
- NCT05878717 — A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease · Phase 2, PHASE3 · recruiting
Other Coordinación de Investigación en Salud, Mexico trials
Trials by the same sponsor.
- NCT07248813 — Telerehabilitation Program to Improve Function in People With Chronic Low Back Pain Compared With Conventional Care · NA · recruiting
- NCT07248891 — Type 2 Diabetes and Associated Factors in Mexico · enrolling by invitation
- NCT06847373 — Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity · NA · recruiting
- NCT07248761 — Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Tri · Phase 4 · active not recruiting
- NCT06782737 — Mediterranean Diet Versus Standard Diet on Candiormetabolic Indicator in Patients With Apnea · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06105073 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Coordinación de Investigación en Salud, Mexico
- Last refreshed: 2 February 2024
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