Bronchiectasis AdultPhysioBXNCT07733323
Respiratory Physiotherapy for Patients With Bronchiectasis
An observational study of Bronchiectasis Adult, run by Yolanda Sanesteban Hermida at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- How many people
- 270 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jul 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study analyses a cohort of 270 adult patients from the A Coruña and Cee health district who were diagnosed with bronchiectasis at the Pulmonology Department of A Coruña Hospital via computed tomography and treated at the Respiratory Physiotherapy Unit of the Rehabilitation Department at A Coruña Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Marítimo de Oza, Hospital a Coruña, SERGAS
A Coruña, A, 15006
About this study
Official title: Analysis of the Profile of Patients Diagnosed With Bronchiectasis Referred to the Respiratory Physiotherapy Unit of the Rehabilitation Service in the A Coruña and Cee Health Area: a Retrospective Observational Study.
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:
Read more
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.
Read the detailed description
The applicability of the study is based on the following aspects:
- Generation of real-world data The retrospective analysis will provide information derived from routine clinical practice, complementing the evidence from clinical trials and providing data representative of the healthcare context within the Galician health system.
- Potential improvement in clinical practice The identification of clinical profiles, associated comorbidities and variables related to disease progression may help to optimise clinical follow-up models, facilitate risk stratification and promote more personalised care for patients with BX.
- Organisational impact and healthcare efficiency Understanding the characteristics and care needs of this cohort will help to guide future organisational strategies, improve resource planning and facilitate interventions aimed at reducing exacerbations, hospitalisations and avoidable healthcare utilisation.
- Basis for future lines of research The results obtained may generate hypotheses for subsequent prospective studies and multicentre projects, contributing to the development of clinical research into chronic respiratory conditions within the public healthcare system.
- Ethical proportionality and risk minimisation As this is a single-centre, retrospective, observational study based exclusively on the review of existing clinical data, with no intervention in patients' care or modification of their clinical management, the risk to participants is minimal. The data will be processed in a pseudonymised form, ensuring confidentiality in accordance with Regulation (EU) 2016/679 and current Spanish legislation on personal data protection and biomedical research.
Overall, the project has high clinical and organisational applicability, as it generates knowledge that is directly transferable to clinical practice, with an appropriate risk-benefit balance and clear social value aimed at improving healthcare for patients with BX.
METHODOLOGY Scope of the study The study population will consist of 270 patients diagnosed with BX who are being treated at the Respiratory Rehabilitation Unit of the Rehabilitation Service in the A Coruña and Cee area, referred from the Pulmonology Department at HUAC. Data will be collected retrospectively through a review of medical records.
Study period The period over which data will be collected will run from 1 January 2022 to 1 March 2026.
Sample size A sample size of 270 patients will allow the characteristics of the cohort to be estimated with a 95% confidence level and a precision of ±11%, assuming an expected prevalence of 50%, thereby ensuring a sufficient sample size. A follow-up loss rate of 10% has been estimated.
Sample selection Non-probabilistic consecutive sampling will be used, including all patients who meet the inclusion criteria during the specified period. Given the retrospective design, available medical records will be systematically reviewed to ensure that all eligible cases are included in the analysis.
LIMITATIONS
This study has a number of limitations inherent to its methodological design which must be taken into account when interpreting the results:
- Retrospective design
- As this is a retrospective observational study based on the review of medical records, the information available will depend on the quality and completeness of the existing clinical records; data may be incomplete or not systematically recorded.
- Possible reporting bias Data collection from healthcare records may lead to variability in the measurement or documentation of certain clinical, functional or microbiological variables, which could introduce reporting bias.
- Single-centre study The single-centre nature of the study may limit the external generalisability of the results to other populations or healthcare settings with different characteristics. However, it allows for greater consistency in diagnostic criteria and in the clinical practice applied.
- Lack of experimental control Given the observational design, it is not possible to establish causal relationships between the variables analysed; the study is limited to identifying clinical associations.
- Missing data It is to be expected that some variables will have missing values due to the retrospective nature of the study. This issue will be addressed through a case-n-necessary analysis, describing the proportion of missing data for each variable analysed.
- Variability in clinical follow-up The duration of follow-up and the frequency of assessments may vary between patients depending on standard clinical practice, which may influence the comparison of long-term outcomes.
Despite these limitations, the study provides relevant information derived from real-world clinical practice, which is a strength for understanding the characteristics and clinical course of patients with BX in the usual clinical setting.
- Conditions
- Bronchiectasis Adult
- Keywords
- E-FACED, bronchiectasis, pulmonary rehabilitation, respiratory muscle training, breathing exercise, computed tomography, microbiology, respiratory physiotherapy, airway clearance techniques
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bronchiectasis | Pulmonary Rehabilitation Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric characteristics
Age (years)
Measured: Baseline
Anthropometric characteristics
Gender: female/male.
Measured: Baseline
Anthropometric characteristics
Height (metres)
Measured: Baseline
Anthropometric characteristics
Weight ( kilograms)
Measured: Baseline
Anthropometric characteristics
Body mass index (BMI). Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline
Lifestyle habits
- Smoking status: yes/no
- Former smoker: yes/no (defined as having given up smoking for ≥ 4 months).
Measured: Baseline
Characteristics of the pathological process: aetiology.
Post-infectious, inflammatory, immunological, congenital or other
Measured: Baseline
Radiological findings:
Confirmation of the diagnosis using high-resolution computed tomography, type of bronchiectasis and radiological extent.
Measured: Baseline
Clinical findings. Modified Medical Research Council Dyspnoea Scale
The Modified Medical Research Council (mMRC) Dyspnoea Scale is a tool for assessing the patient's sensation of breathlessness and is used to classify the severity of dyspnoea into five levels, ranging from zero - which indicates the absence of dyspnoea - to four, which represents severe dyspnoea that limits everyday activities.
Measured: Periprocedural.
Microbiological Analysis of Sputum
Types of bacteria and fungi found in sputum.
Measured: Periprocedural
Laboratory test.
C-reactive protein (CRP), measured in mg/L
Measured: Values recorded in the most recent laboratory test in the medical record at the time the respiratory physical therapy program begins.
Bronchiectasis severity scale: E-FACED
It is a multidimensional tool that enables the stratification of the risk of exacerbations, hospitalisations and mortality.
It is valued exacerbations, spirometric data, age, pseudomonas colonisation, computed tomography extent and dyspnoea.Each variable is scored on a dichotomous scale, with a total range of increasing severity from 0 to 9 points, where 0-3 points indicate mild bronchiectasis, 4-6 points moderate bronchiectasis and 7-9 points severe bronchiectasis.
Measured: Periprocedural
Pharmacological treatment.
Corticosteroids, antibiotics, inhaled bronchodilators and saline solution.
Measured: Periprocedural
Comorbidities.
Bronchial colonisation and other pulmonary complications (sleep apnoea syndrome (OSA)), cardiovascular, neurological, gastrointestinal (hiatal hernia), rheumatic, oncological or osteoarticular conditions.
Measured: Baseline
Exacerbations of bronchiectasis
Number of hospital admissions prior to respiratory physiotherapy treatment
Measured: The year prior to the start of respiratory physiotherapy treatment
Exacerbations of bronchiectasis
Number of readmissions following respiratory physiotherapy treatment
Measured: From the end of treatment up to 1 year later.
Physiotherapy on the ward during hospitalisation
Yes /no
Measured: Periprocedural.
Characteristics of physiotherapy treatment. Type of treatment (by duration):
Physiotherapy treatment 1 (8 weeks, rehabilitation protocol comprising education, bronchial clearance, strength training and aerobic exercise): duration (8 weeks, yes/no), interruptions to the programme and the reason for each interruption.
Physiotherapy treatment 2 (10 sessions comprising education, bronchial clearance and exercise): interruptions and reason for each interruption.
Physiotherapy treatment 3 (1 session comprising education and bronchial clearance).
Measured: Periprocedural.
Treatment techniques used in the pulmonary rehabilitation programme (yes/no).
Health education (use of nebulisers.), bronchial clearance sessions, positive pressure exercises (Acapella, Shaker), use of a volumetric spirometer, therapeutic exercise, strength training, aerobic training.
Measured: Periprocedural.
Treatment compliance
Non-compliant category based on attendance records and adherence to sessions.
Measured: Periprocedural.
Lung function: spirometry.
Spirometry is a respiratory function test that measures respiratory flow rates and volumes, which are useful for the diagnosis and monitoring of respiratory conditions.
The spirometry results recorded in the medical records are compared: those taken before and after physiotherapy treatment.
Measured: Periprocedural.
Strength of the inspiratory muscles.
Measuring maximum inspiratory pressures (MIP) allows the strength of the inspiratory muscles to be assessed. These are simple, quick and non-invasive measurements. They involve the patient generating the maximum inspiratory pressure, measured in cmH₂O (starting from residual volume), against an occluded system. MIP primarily assesses diaphragmatic strength and is of great clinical utility in the diagnosis and monitoring of conditions affecting the respiratory muscles.
Measured: Periprocedural
Strength of the expiratory muscles.
Measuring peak expiratory pressures (MEP) allows the strength of the expiratory muscles to be assessed. These are simple, quick and non-invasive measurements. They involve the patient generating maximum expiratory pressure (from total lung capacity) against an occluded system. MEP is measured in cmH₂O and primarily assesses the strength of the intercostal and abdominal muscles. MEP are of great clinical utility in the diagnosis and monitoring of conditions affecting the respiratory muscles.
Measured: Periprocedural
Physical and functional capacity: The six-minute walk test (6MWT)
The six-minute walk test (6MWT) is a functional assessment used to measure exercise capacity and the cardiorespiratory response to exertion under controlled conditions.
It involves determining the maximum distance a person can walk on a flat surface over a period of six minutes. In addition, oxygen saturation is measured using pulse oximetry throughout the test. It is widely used to assess tolerance to physical exertion, monitor the progression of various respiratory conditions and estimate the functional prognosis of diseases in a clinical setting.
Measured: Periprocedural.
Physical and functional capacity : Sit-to-Stand Test (1STST)
The Sit-to-Stand Test is a test that assesses the functional strength of the lower limbs and involves the person sitting down and standing up from a chair as many times as possible in 1 minute .
Measured: Periprocedural.
Physical and functional capacity : submaximal cycle ergometer test.
A submaximal cycle ergometer test is a stress test carried out on a stationary bicycle in which the patient is not required to exert themselves to their maximum capacity. The aim is to assess the cardiovascular, respiratory and functional responses during moderate-intensity exercise. The following are measured: watts, the duration of the test and the reason for failure.
Measured: Periprocedural.
Physical and functional capacity: submaximal test on a treadmill
A submaximal treadmill test is a stress test carried out on a treadmill in which the patient walks at a moderate intensity, without reaching maximum exertion. Its aim is to assess the response to exercise and functional capacity in a safe manner. The duration of the test, the angle of inclination reached and the reason for giving up are measured.
Measured: Periprocedural
Clinical findings
An assessment is made as to whether the patient is experiencing a cough, sputum production or haemoptysis (yes/no) at the time of physiotherapy treatment.
Measured: Periprocedural.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start7 Jul 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yolanda Sanesteban Hermida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yolanda Sanesteban Hermida, Fundación Pública Galega de Investigación Biomédica INIBIC
- Investigators
- Yolanda Y Sanesteban-Hermida, PT MSc, Principal investigator, INIBIC, SERGAS, Universidad A CoruñaBeatriz B Rodriguez-Romero, PT PhD, Study director, Universidad A CoruñaEstíbaliz E Díaz-Balboa, PT PhD, Study director, Universidad A CoruñaJacobo J Formigo-Couceiro, Doctor en Rehabilitación, Study director, Instituto de Investigacion Biomedica de A CorunaMarina M Blanco-Aparicio, Doctora en Neumología, Study director, Sergas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733323
- Sponsor's protocol ID
- 2026/244
- Other IDs
- 2026/244
- Acronym
- PhysioBX
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee AL, Hill CJ, McDonald CF, Holland AE. Pulmonary Rehabilitation in Individuals With Non-Cystic Fibrosis Bronchiectasis: A Systematic Review. Arch Phys Med Rehabil. 2017 Apr;98(4):774-782.e1. doi: 10.1016/j.apmr.2016.05.017. Epub 2016 Jun 16.
PubMed 27320420Martinez-Garcia MA, Maiz L, Olveira C, Giron RM, de la Rosa D, Blanco M, Canton R, Vendrell M, Polverino E, de Gracia J, Prados C. Spanish Guidelines on Treatment of Bronchiectasis in Adults. Arch Bronconeumol (Engl Ed). 2018 Feb;54(2):88-98. doi: 10.1016/j.arbres.2017.07.016. Epub 2017 Nov 9. English, Spanish.
PubMed 29128129Herrero-Cortina B, Lee AL, Oliveira A, O'Neill B, Jacome C, Dal Corso S, Poncin W, Munoz G, Inal-Ince D, Alcaraz-Serrano V, Reychler G, Bellofiore A, Posthumus A; Patient representative; Tonia T, Chalmers JD, Spinou A. European Respiratory Society statement on airway clearance techniques in adults with bronchiectasis. Eur Respir J. 2023 Jul 20;62(1):2202053. doi: 10.1183/13993003.02053-2022. Print 2023 Jul.
PubMed 37142337Martinez-Garcia MA, Athanazio RA, Giron R, Maiz-Carro L, de la Rosa D, Olveira C, de Gracia J, Vendrell M, Prados-Sanchez C, Gramblicka G, Corso Pereira M, Lundgren FL, Fernandes De Figueiredo M, Arancibia F, Rached SZ. Predicting high risk of exacerbations in bronchiectasis: the E-FACED score. Int J Chron Obstruct Pulmon Dis. 2017 Jan 18;12:275-284. doi: 10.2147/COPD.S121943. eCollection 2017.
PubMed 28182132Martí-Romeu JD, Vendrell Relat M, coords. Manual SEPAR de procedimientos 27: Técnicas manuales e instrumentales para el drenaje de secreciones bronquiales en el paciente adulto [Internet]. Barcelona: Respira-Fundación Española del Pulmón-SEPAR. Disponible en: https://issuu.com/separ/docs/manual__separ_27_tecnicas_manuales_/1
Burgos F, Casan P, coordinadores. Manual SEPAR de procedimientos. Módulo 4. Procedimientos de evaluación de la función pulmonar II. Barcelona: Publicaciones Permanyer; 2004. 144 p.
Güell Rous MR, Díaz Lobato S, Rodríguez Trigo G, Morante Vélez F, San Miguel M, Cejudo P, et al. Rehabilitación respiratoria. ArchBronconeumol [Internet]. 2014 Aug 1 [cited 2022 Jun 9];50(8):332-44. Disponible en: https://www.archbronconeumol.org/en-rehabilitacion-respiratoria-articulo-S0300289614000878
Calvo JS, Bellido VG, Sousa JLA. Sistema respiratorio: métodos, fisioterapia clínica y afecciones para fisioterapeutas. Editorial Médica Panamericana; 2018.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Profile of Patients Diagnosed With Bronchiectasis Referred to the Respiratory Physiotherapy Unit of the Rehabilitation Service in the A Coruña and Cee Health Area: a Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT07733323
- Acronym / sponsor ID
- PhysioBX / 2026/244
- Conditions
- Bronchiectasis Adult
- Keywords
- E-FACED, bronchiectasis, pulmonary rehabilitation, respiratory muscle training, breathing exercise, computed tomography, microbiology, respiratory physiotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Yolanda Sanesteban HermidaUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The applicability of the study is based on the following aspects:
- Generation of real-world data The retrospective analysis will provide information derived from routine clinical practice, complementing the evidence from clinical trials and providing data representative of the healthcare context within the Galician health system.
- Potential improvement in clinical practice The identification of clinical profiles, associated comorbidities and variables related to disease progression may help to optimise clinical follow-up models, facilitate risk stratification and promote more personalised care for patients with BX.
- Organisational impact and healthcare efficiency Understanding the characteristics and care needs of this cohort will help to guide future organisational strategies, improve resource planning and facilitate interventions aimed at reducing exacerbations, hospitalisations and avoidable healthcare utilisation.
- Basis for future lines of research The results obtained may generate hypotheses for subsequent prospective studies and multicentre projects, contributing to the development of clinical research into chronic respiratory conditions within the public healthcare system.
- Ethical proportionality and risk minimisation As this is a single-centre, retrospective, observational study based exclusively on the review of existing clinical data, with no intervention in patients' care or modification of their clinical management, the risk to participants is minimal. The data will be processed in a pseudonymised form, ensuring confidentiality in accordance with Regulation (EU) 2016/679 and current Spanish legislation on personal data protection and biomedical research.
Overall, the project has high clinical and organisational applicability, as it generates knowledge that is directly transferable to clinical practice, with an appropriate risk-benefit balance and clear social value aimed at improving healthcare for patients with BX.
METHODOLOGY Scope of the study The study population will consist of 270 patients diagnosed with BX who are being treated at the Respiratory Rehabilitation Unit of the Rehabilitation Service in the A Coruña and Cee area, referred from the Pulmonology Department at HUAC. Data will be collected retrospectively through a review of medical records.
Study period The period over which data will be collected will run from 1 January 2022 to 1 March 2026.
Sample size A sample size of 270 patients will allow the characteristics of the cohort to be estimated with a 95% confidence level and a precision of ±11%, assuming an expected prevalence of 50%, thereby ensuring a sufficient sample size. A follow-up loss rate of 10% has been estimated.
Sample selection Non-probabilistic consecutive sampling will be used, including all patients who meet the inclusion criteria during the specified period. Given the retrospective design, available medical records will be systematically reviewed to ensure that all eligible cases are included in the analysis.
LIMITATIONS
This study has a number of limitations inherent to its methodological design which must be taken into account when interpreting the results:
- Retrospective design
- As this is a retrospective observational study based on the review of medical records, the information available will depend on the quality and completeness of the existing clinical records; data may be incomplete or not systematically recorded.
- Possible reporting bias Data collection from healthcare records may lead to variability in the measurement or documentation of certain clinical, functional or microbiological variables, which could introduce reporting bias.
- Single-centre study The single-centre nature of the study may limit the external generalisability of the results to other populations or healthcare settings with different characteristics. However, it allows for greater consistency in diagnostic criteria and in the clinical practice applied.
- Lack of experimental control Given the observational design, it is not possible to establish causal relationships between the variables analysed; the study is limited to identifying clinical associations.
- Missing data It is to be expected that some variables will have missing values due to the retrospective nature of the study. This issue will be addressed through a case-n-necessary analysis, describing the proportion of missing data for each variable analysed.
- Variability in clinical follow-up The duration of follow-up and the frequency of assessments may vary between patients depending on standard clinical practice, which may influence the comparison of long-term outcomes.
Despite these limitations, the study provides relevant information derived from real-world clinical practice, which is a strength for understanding the characteristics and clinical course of patients with BX in the usual clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bronchiectasis | – | –Pulmonary Rehabilitation Programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study analyses a cohort of 270 adult patients from the A Coruña and Cee health district who were diagnosed with bronchiectasis at the Pulmonology Department of A Coruña Hospital via computed tomography and treated at the Respiratory Physiotherapy Unit of the Rehabilitation Department at A Coruña Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anthropometric characteristics
Time frame: Baseline
Age (years)
Anthropometric characteristics
Time frame: Baseline
Gender: female/male.
Anthropometric characteristics
Time frame: Baseline
Height (metres)
Anthropometric characteristics
Time frame: Baseline
Weight ( kilograms)
Anthropometric characteristics
Time frame: Baseline
Body mass index (BMI). Weight and height will be combined to report BMI in kg/m^2.
Lifestyle habits
Time frame: Baseline
* Smoking status: yes/no * Former smoker: yes/no (defined as having given up smoking for ≥ 4 months).
Characteristics of the pathological process: aetiology.
Time frame: Baseline
Post-infectious, inflammatory, immunological, congenital or other
Radiological findings:
Time frame: Baseline
Confirmation of the diagnosis using high-resolution computed tomography, type of bronchiectasis and radiological extent.
Clinical findings. Modified Medical Research Council Dyspnoea Scale
Time frame: Periprocedural.
The Modified Medical Research Council (mMRC) Dyspnoea Scale is a tool for assessing the patient's sensation of breathlessness and is used to classify the severity of dyspnoea into five levels, ranging from zero - which indicates the absence of dyspnoea - to four, which represents severe dyspnoea that limits everyday activities.
Microbiological Analysis of Sputum
Time frame: Periprocedural
Types of bacteria and fungi found in sputum.
Laboratory test.
Time frame: Values recorded in the most recent laboratory test in the medical record at the time the respiratory physical therapy program begins.
C-reactive protein (CRP), measured in mg/L
Bronchiectasis severity scale: E-FACED
Time frame: Periprocedural
It is a multidimensional tool that enables the stratification of the risk of exacerbations, hospitalisations and mortality. It is valued exacerbations, spirometric data, age, pseudomonas colonisation, computed tomography extent and dyspnoea.Each variable is scored on a dichotomous scale, with a total range of increasing severity from 0 to 9 points, where 0-3 points indicate mild bronchiectasis, 4-6 points moderate bronchiectasis and 7-9 points severe bronchiectasis.
Pharmacological treatment.
Time frame: Periprocedural
Corticosteroids, antibiotics, inhaled bronchodilators and saline solution.
Comorbidities.
Time frame: Baseline
Bronchial colonisation and other pulmonary complications (sleep apnoea syndrome (OSA)), cardiovascular, neurological, gastrointestinal (hiatal hernia), rheumatic, oncological or osteoarticular conditions.
Exacerbations of bronchiectasis
Time frame: The year prior to the start of respiratory physiotherapy treatment
Number of hospital admissions prior to respiratory physiotherapy treatment
Exacerbations of bronchiectasis
Time frame: From the end of treatment up to 1 year later.
Number of readmissions following respiratory physiotherapy treatment
Physiotherapy on the ward during hospitalisation
Time frame: Periprocedural.
Yes /no
Characteristics of physiotherapy treatment. Type of treatment (by duration):
Time frame: Periprocedural.
Physiotherapy treatment 1 (8 weeks, rehabilitation protocol comprising education, bronchial clearance, strength training and aerobic exercise): duration (8 weeks, yes/no), interruptions to the programme and the reason for each interruption. Physiotherapy treatment 2 (10 sessions comprising education, bronchial clearance and exercise): interruptions and reason for each interruption. Physiotherapy treatment 3 (1 session comprising education and bronchial clearance).
Treatment techniques used in the pulmonary rehabilitation programme (yes/no).
Time frame: Periprocedural.
Health education (use of nebulisers.), bronchial clearance sessions, positive pressure exercises (Acapella, Shaker), use of a volumetric spirometer, therapeutic exercise, strength training, aerobic training.
Treatment compliance
Time frame: Periprocedural.
Non-compliant category based on attendance records and adherence to sessions.
Lung function: spirometry.
Time frame: Periprocedural.
Spirometry is a respiratory function test that measures respiratory flow rates and volumes, which are useful for the diagnosis and monitoring of respiratory conditions. The spirometry results recorded in the medical records are compared: those taken before and after physiotherapy treatment.
Strength of the inspiratory muscles.
Time frame: Periprocedural
Measuring maximum inspiratory pressures (MIP) allows the strength of the inspiratory muscles to be assessed. These are simple, quick and non-invasive measurements. They involve the patient generating the maximum inspiratory pressure, measured in cmH₂O (starting from residual volume), against an occluded system. MIP primarily assesses diaphragmatic strength and is of great clinical utility in the diagnosis and monitoring of conditions affecting the respiratory muscles.
Strength of the expiratory muscles.
Time frame: Periprocedural
Measuring peak expiratory pressures (MEP) allows the strength of the expiratory muscles to be assessed. These are simple, quick and non-invasive measurements. They involve the patient generating maximum expiratory pressure (from total lung capacity) against an occluded system. MEP is measured in cmH₂O and primarily assesses the strength of the intercostal and abdominal muscles. MEP are of great clinical utility in the diagnosis and monitoring of conditions affecting the respiratory muscles.
Physical and functional capacity: The six-minute walk test (6MWT)
Time frame: Periprocedural.
The six-minute walk test (6MWT) is a functional assessment used to measure exercise capacity and the cardiorespiratory response to exertion under controlled conditions. It involves determining the maximum distance a person can walk on a flat surface over a period of six minutes. In addition, oxygen saturation is measured using pulse oximetry throughout the test. It is widely used to assess tolerance to physical exertion, monitor the progression of various respiratory conditions and estimate the functional prognosis of diseases in a clinical setting.
Physical and functional capacity : Sit-to-Stand Test (1STST)
Time frame: Periprocedural.
The Sit-to-Stand Test is a test that assesses the functional strength of the lower limbs and involves the person sitting down and standing up from a chair as many times as possible in 1 minute .
Physical and functional capacity : submaximal cycle ergometer test.
Time frame: Periprocedural.
A submaximal cycle ergometer test is a stress test carried out on a stationary bicycle in which the patient is not required to exert themselves to their maximum capacity. The aim is to assess the cardiovascular, respiratory and functional responses during moderate-intensity exercise. The following are measured: watts, the duration of the test and the reason for failure.
Physical and functional capacity: submaximal test on a treadmill
Time frame: Periprocedural
A submaximal treadmill test is a stress test carried out on a treadmill in which the patient walks at a moderate intensity, without reaching maximum exertion. Its aim is to assess the response to exercise and functional capacity in a safe manner. The duration of the test, the angle of inclination reached and the reason for giving up are measured.
Clinical findings
Time frame: Periprocedural.
An assessment is made as to whether the patient is experiencing a cough, sputum production or haemoptysis (yes/no) at the time of physiotherapy treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 27320420Lee AL, Hill CJ, McDonald CF, Holland AE. Pulmonary Rehabilitation in Individuals With Non-Cystic Fibrosis Bronchiectasis: A Systematic Review. Arch Phys Med Rehabil. 2017 Apr;98(4):774-782.e1. doi: 10.1016/j.apmr.2016.05.017. Epub 2016 Jun 16.
- Background: PubMed 29128129Martinez-Garcia MA, Maiz L, Olveira C, Giron RM, de la Rosa D, Blanco M, Canton R, Vendrell M, Polverino E, de Gracia J, Prados C. Spanish Guidelines on Treatment of Bronchiectasis in Adults. Arch Bronconeumol (Engl Ed). 2018 Feb;54(2):88-98. doi: 10.1016/j.arbres.2017.07.016. Epub 2017 Nov 9. English, Spanish.
- Background: PubMed 37142337Herrero-Cortina B, Lee AL, Oliveira A, O'Neill B, Jacome C, Dal Corso S, Poncin W, Munoz G, Inal-Ince D, Alcaraz-Serrano V, Reychler G, Bellofiore A, Posthumus A; Patient representative; Tonia T, Chalmers JD, Spinou A. European Respiratory Society statement on airway clearance techniques in adults with bronchiectasis. Eur Respir J. 2023 Jul 20;62(1):2202053. doi: 10.1183/13993003.02053-2022. Print 2023 Jul.
- Background: PubMed 28182132Martinez-Garcia MA, Athanazio RA, Giron R, Maiz-Carro L, de la Rosa D, Olveira C, de Gracia J, Vendrell M, Prados-Sanchez C, Gramblicka G, Corso Pereira M, Lundgren FL, Fernandes De Figueiredo M, Arancibia F, Rached SZ. Predicting high risk of exacerbations in bronchiectasis: the E-FACED score. Int J Chron Obstruct Pulmon Dis. 2017 Jan 18;12:275-284. doi: 10.2147/COPD.S121943. eCollection 2017.
- BackgroundMartí-Romeu JD, Vendrell Relat M, coords. Manual SEPAR de procedimientos 27: Técnicas manuales e instrumentales para el drenaje de secreciones bronquiales en el paciente adulto [Internet]. Barcelona: Respira-Fundación Española del Pulmón-SEPAR. Disponible en: https://issuu.com/separ/docs/manual__separ_27_tecnicas_manuales_/1
- BackgroundBurgos F, Casan P, coordinadores. Manual SEPAR de procedimientos. Módulo 4. Procedimientos de evaluación de la función pulmonar II. Barcelona: Publicaciones Permanyer; 2004. 144 p.
- BackgroundGüell Rous MR, Díaz Lobato S, Rodríguez Trigo G, Morante Vélez F, San Miguel M, Cejudo P, et al. Rehabilitación respiratoria. ArchBronconeumol [Internet]. 2014 Aug 1 [cited 2022 Jun 9];50(8):332-44. Disponible en: https://www.archbronconeumol.org/en-rehabilitacion-respiratoria-articulo-S0300289614000878
- Results publicationCalvo JS, Bellido VG, Sousa JLA. Sistema respiratorio: métodos, fisioterapia clínica y afecciones para fisioterapeutas. Editorial Médica Panamericana; 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda Y Sanesteban-Hermida, PT MSc principal investigator
INIBIC, SERGAS, Universidad A Coruña
Beatriz B Rodriguez-Romero, PT PhD study director
Universidad A Coruña
Estíbaliz E Díaz-Balboa, PT PhD study director
Universidad A Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by Yolanda Sanesteban Hermida at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric characteristics (time frame: Baseline). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07733323, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.