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NCT Number: NCT07104942

Effect of Expiratory Muscle Strength in Patients With Bronchiectasis

This study investigates the relationship between expiratory muscle strength and clinical outcomes such as disease severity, hospital admissions, and quality of life in individuals with bronchiectasis.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nisanur Tutuş

CONTACT

[email protected]

(0216) 421 42 00 ext. 1352

About this study

This study aims to examine the relationship between expiratory muscle strength and clinical outcomes such as disease severity, hospital admission history, and quality of life in individuals with bronchiectasis. Effective coughing is a critical physiological reflex for airway clearance; however, the relationship between expiratory muscle strength and cough effectiveness in the bronchiectasis population has not been clearly established. Identifying expiratory muscle weakness as a potential contributor to increased symptom burden and impaired airway clearance may improve clinical understanding and support the development of targeted physiotherapy interventions. The findings of this study could serve as a foundation for future interventional research in pulmonary rehabilitation and respiratory muscle training for this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having a diagnosis of non-cystic fibrosis bronchiectasis
  • Without an acute infection at the time of assessment (confirmed by medical history, serum C-reactive protein levels, chest X-ray and/or HRCT).
  • Being between 18 and 65 years of age

Exclusion criteria

  • Myopathies
  • Stroke (Cerebrovascular accident - CVA)
  • Pregnancy
  • Unstable cardiac disease

Treatment and study plan

Primary outcomes

  1. Respiratory Muscle Strength

    Time frame: Baseline

    Respiratory muscle function will be assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in the sitting position using a mouth pressure device (MEC PFT Systems Pocket-Spiro).

Secondary outcomes

  1. Modified Medical Research Council Dyspnea Score

    Time frame: Baseline

    Modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4 point" means severe dyspnea perception.

  2. Leicester Cough Questionnaire

    Time frame: Baseline

    This is a short questionnaire that assesses quality of life, particularly for chronic cough. It is relatively easy to administer. The Leicester Cough Questionnaire consists of nineteen questions assessing three different areas: physical, social, and psychological. Scores for the LCQ include mean scores for each domain (ranging from 1 to 7) and a total score calculated as the sum of the domain scores (ranging from 3 to 21). Higher scores indicate better quality of life.

  3. Bronchiectasis Severity Index

    Time frame: Baseline

    The Bronchiectasis Severity Index (BSI) will be used to determine disease severity. This index examines nine parameters: age, body mass index, % predicted FEV1, hospitalizations due to exacerbations in the last 2 years, number of exacerbations in the previous year, level of dyspnea, colonization by Pseudomaonas and other microorganisms, and radiological findings. These scores classify patients into mild (0-4 points), moderate (5-8 points), and severe (9 points and above) groups and identify patients at risk of death, hospitalization and exacerbations.

  4. Hospital Anxiety Depression Scale

    Time frame: Baseline

    This is a 14-item scale developed by Zigmond and Snaith. Seven of these items assess anxiety symptoms, and seven assess depression symptoms. The items in the scale are assessed using a 4-point Likert scale and are based on a scoring system ranging from 0 to 3. Scores range from 0 to 21 for each subscale and can be summed to yield a total anxiety-depression score of up to 42. Higher scores indicate increased symptom severity, while a cut-off score of 8 indicates high levels of depression and anxiety symptoms.

  5. Fatigue severity scale

    Time frame: Baseline

    Individuals' fatigue levels will be assessed using the Fatigue Severity Scale (FSS). The FSS consists of 9 questions scored on a 7-point Likert scale, indicating a perceived level of fatigue that may require medical attention. It is a valid and reliable instrument, with a score of 7 being associated with greater fatigue.

  6. Spirometric measurements (Forced vital capacity)

    Time frame: Baseline

    It is used to evaluate respiratory functions. It is evaluated with a spirometer. Forced vital capacity (FVC): the maximum amount of air that can be forcibly exhaled from the lungs after fully inhaling. It can be recorded in percentages or liters.

  7. Spirometric measurements (First second forced expiratory volume)

    Time frame: Baseline

    It is used to evaluate respiratory functions. It is evaluated with a spirometer. First-second forced expiratory volume (FEV1): the amount of air that can be exhaled with force in 1 second. It can be recorded in percentages or liters.

  8. Spirometric measurements (FEV1/FVC ratio)

    Time frame: Baseline

    It is used to evaluate respiratory functions. It is evaluated with a spirometer. It is calculated by dividing FEV1 by FVC. It is expressed as a percentage.

Study contacts

Contact information is provided by the study sponsor or research team.

Nisanur Tutuş

CONTACT

[email protected]

(0216) 421 42 00 ext. 1352

Sponsors and collaborators

Lead sponsor

Nisanur Tutuş

Other

Registry information

Official study title

Effect of Expiratory Muscle Strength on Hospital Admission, Disease Severity and Quality of Life in Patients With Bronchiectasis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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