Respiratory Physiotherapy for Patients With Bronchiectasis

Condition(s) studied

Study 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

Primary outcome measure(s)

• Anthropometric characteristics — Baseline
  Age (years)
• Anthropometric characteristics — Baseline
  Gender: female/male.
• Anthropometric characteristics — Baseline
  Height (metres)
• Anthropometric characteristics — Baseline
  Weight ( kilograms)
• Anthropometric characteristics — Baseline
  Body mass index (BMI). Weight and height will be combined to report BMI in kg/m\^2.
• Lifestyle habits — Baseline
  * Smoking status: yes/no * Former smoker: yes/no (defined as having given up smoking for ≥ 4 months).
• Characteristics of the pathological process: aetiology. — Baseline
  Post-infectious, inflammatory, immunological, congenital or other
• Radiological findings: — Baseline
  Confirmation of the diagnosis using high-resolution computed tomography, type of bronchiectasis and radiological extent.
• Clinical findings. Modified Medical Research Council Dyspnoea Scale — 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 — Periprocedural
  Types of bacteria and fungi found in sputum.
• Laboratory test. — 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 — 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. — Periprocedural
  Corticosteroids, antibiotics, inhaled bronchodilators and saline solution.
• Comorbidities. — Baseline
  Bronchial colonisation and other pulmonary complications (sleep apnoea syndrome (OSA)), cardiovascular, neurological, gastrointestinal (hiatal hernia), rheumatic, oncological or osteoarticular conditions.
• Exacerbations of bronchiectasis — The year prior to the start of respiratory physiotherapy treatment
  Number of hospital admissions prior to respiratory physiotherapy treatment
• Exacerbations of bronchiectasis — From the end of treatment up to 1 year later.
  Number of readmissions following respiratory physiotherapy treatment
• Physiotherapy on the ward during hospitalisation — Periprocedural.
  Yes /no
• Characteristics of physiotherapy treatment. Type of treatment (by duration): — 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). — 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 — Periprocedural.
  Non-compliant category based on attendance records and adherence to sessions.
• Lung function: spirometry. — 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. — 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. — 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) — 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) — 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. — 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 — 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 — 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.

Trial sites (1)

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