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Active Not Recruiting
NCT07733323
Respiratory Physiotherapy for Patients With Bronchiectasis
Conditions: Bronchiectasis Adult
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 270
Sponsor: Yolanda Sanesteban Hermida
Location: Hospital Marítimo de Oza, Hospital a Coruña, SERGAS A Coruña A
Summary
Study design: observational, retrospective Population: 270 patients diagnosed with bronchiectasis (BX) treated at the Respiratory Physiotherapy Unit of the Rehabilitation Service of the A Coruña and Cee Health Area.
Objective:
To determine the profile of patients diagnosed with BX (not due to cystic fibrosis) treated at the Respiratory Physiotherapy Unit of the Rehabilitation Service of the A Coruña and Cee Health Area between 1 January 2022 and 1 March 2026.
Hypotheses:
* Main hypothesis These patients exhibit a high degree of heterogeneity. It is expected that the characterisation of these patients' clinical and functional variables-such as lung function, respiratory muscle strength, frequency of exacerbations and chronic bronchial colonisation by microorganisms-will enable the identification of distinct patterns within this population.
* Secondary hypotheses
* Patients with a higher burden of comorbidity have a poorer clinical prognosis and make greater use of resources.
* Respiratory rehabilitation interventions will lead to improvements in these variables.
* The combined analysis of clinical, functional and microbiological variables will enable the identification of patient profiles at higher risk.
Applicability: The study will provide specific and up-to-date knowledge, enabling the optimisation of follow-up strategies and the adaptation of RF interventions to patients' actual needs, thereby improving the quality of care. The results will contribute to the formulation of new research questions.
Ethical considerations: The information will be processed in a pseudonymised manner, ensuring the confidentiality and security of the data in accordance with the General Data Protection Regulation. Given the retrospective nature of the study and compliance with the established pseudonymisation requirements, an exemption from informed consent will be requested from the Ethics Committee, in accordance with Additional Provision 17 of Organic Law 3/2018, relating to the processing of health data for research purposes, justified by the minimal risk involved and the privacy controls in place for the information.
Estimated duration: 9-10 months from the date of approval by the Ethics Committee, including data collection, statistical analysis and the dissemination of results.
Budget: No external funding required. Conclusion: This project will provide detailed and rigorous clinical information on patients with bronchiectasis in real-world clinical practice.
Eligibility Criteria
Inclusion criteria:
* Patients diagnosed with BX via imaging studies such as high-resolution computed tomography, in accordance with validated clinical and radiological criteria.
* Patients treated at the Respiratory Rehabilitation Unit of the Rehabilitation Service in the A Coruña and Cee area between 1 January 2022 and 1 March 2026, having completed the physiotherapy intervention programme.
* Adult patients, aged ≥18 years at the time of diagnosis.
* Minimum information available in the electronic health record, including: demographic data (age, sex); data on bronchial colonisation; data on lung function (spirometry); records of exacerbations and/or hospital admissions; and data on respiratory treatments received.
Exclusion criteria:
* Patients with an uncertain or unconfirmed diagnosis of BX.
* Patients with a diagnosis of cystic fibrosis.
* Incomplete medical records that prevent the collection of variables essential to the study.
Source: ClinicalTrials.gov (NCT07733323). StuddyBuddy aggregates publicly available trial information.