Respiratory Physiotherapy for Patients With Bronchiectasis

NCT07733323 | Active Not Recruiting

• 1 other identifier: 2026/244
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiectasis Adult

Keywords

E-FACED; bronchiectasis; pulmonary rehabilitation; respiratory muscle training; breathing exercise; computed tomography; microbiology; respiratory physiotherapy; airway clearance techniques

Outcome Measures

Primary Outcomes (28)

• Anthropometric characteristics

  Age (years)

  Baseline

• Anthropometric characteristics

  Gender: female/male.

  Baseline

• Anthropometric characteristics

  Height (metres)

  Baseline

• Anthropometric characteristics

  Weight ( kilograms)

  Baseline

• Anthropometric characteristics

  Body mass index (BMI). Weight and height will be combined to report BMI in kg/m\^2.

  Baseline

• Lifestyle habits

  * Smoking status: yes/no * Former smoker: yes/no (defined as having given up smoking for ≥ 4 months).

  Baseline

• Characteristics of the pathological process: aetiology.

  Post-infectious, inflammatory, immunological, congenital or other

  Baseline

• Radiological findings:

  Confirmation of the diagnosis using high-resolution computed tomography, type of bronchiectasis and radiological extent.

  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.

  Periprocedural.

• Microbiological Analysis of Sputum

  Types of bacteria and fungi found in sputum.

  Periprocedural

• Laboratory test.

  C-reactive protein (CRP), measured in mg/L

  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.

  Periprocedural

• Pharmacological treatment.

  Corticosteroids, antibiotics, inhaled bronchodilators and saline solution.

  Periprocedural

• Comorbidities.

  Bronchial colonisation and other pulmonary complications (sleep apnoea syndrome (OSA)), cardiovascular, neurological, gastrointestinal (hiatal hernia), rheumatic, oncological or osteoarticular conditions.

  Baseline

• Exacerbations of bronchiectasis

  Number of hospital admissions prior to respiratory physiotherapy treatment

  The year prior to the start of respiratory physiotherapy treatment

• Exacerbations of bronchiectasis

  Number of readmissions following respiratory physiotherapy treatment

  From the end of treatment up to 1 year later.

• Physiotherapy on the ward during hospitalisation

  Yes /no

  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).

  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.

  Periprocedural.

• Treatment compliance

  Non-compliant category based on attendance records and adherence to sessions.

  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.

  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.

  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.

  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.

  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 .

  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.

  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.

  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.

  Periprocedural.

Study Arms (1)

Patients with bronchiectasis

Pulmonary Rehabilitation Programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yolanda Sanesteban Hermida: lead

Study Sites (1)

Hospital Marítimo de Oza, Hospital a Coruña, SERGAS

A Coruña, A, 15006, Spain

Location

Related Publications (8)

• 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.

  PMID: 27320420 BACKGROUND

• Martinez-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.

  PMID: 29128129 BACKGROUND

• Herrero-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.

  PMID: 37142337 BACKGROUND

• Martinez-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.

  PMID: 28182132 BACKGROUND

• Martí-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

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Calvo JS, Bellido VG, Sousa JLA. Sistema respiratorio: métodos, fisioterapia clínica y afecciones para fisioterapeutas. Editorial Médica Panamericana; 2018.

  RESULT

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Yolanda Y Sanesteban-Hermida, PT MSc

  INIBIC, SERGAS, Universidad A Coruña

  PRINCIPAL INVESTIGATOR

• Beatriz B Rodriguez-Romero, PT PhD

  Universidad A Coruña

  STUDY DIRECTOR

• Estíbaliz E Díaz-Balboa, PT PhD

  Universidad A Coruña

  STUDY DIRECTOR

• Jacobo J Formigo-Couceiro, Doctor en Rehabilitación

  Instituto de Investigacion Biomedica de A Coruna

  STUDY DIRECTOR

• Marina M Blanco-Aparicio, Doctora en Neumología

  Sergas

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapist in the Respiratory Physical Therapy Unit of the A Coruña University Hospital Complex

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 29, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)