BronchiectasisNCT07104942
Effect of Expiratory Muscle Strength in Patients With Bronchiectasis
An observational study of Bronchiectasis, run by Nisanur Tutuş at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchiectasis
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2025to Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital
Who may be able to join
- 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
Who cannot join
- Myopathies
- Stroke (Cerebrovascular accident - CVA)
- Pregnancy
- Unstable cardiac disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital
Istanbul
Nisanur Tutuş, (0216) 421 42 00 ext. 1352, nisanurtutuss@gmail.com
About this study
Official title: Effect of Expiratory Muscle Strength on Hospital Admission, Disease Severity and Quality of Life 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.
Read the detailed description
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.
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Expiratory muscle strength
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength
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).
Measured: Baseline
Secondary outcomes (8)
Modified Medical Research Council Dyspnea Score
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.
Measured: Baseline
Leicester Cough Questionnaire
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.
Measured: Baseline
Bronchiectasis Severity Index
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.
Measured: Baseline
Hospital Anxiety Depression Scale
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.
Measured: Baseline
Fatigue severity scale
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.
Measured: Baseline
Spirometric measurements (Forced vital capacity)
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.
Measured: Baseline
Spirometric measurements (First second forced expiratory volume)
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.
Measured: Baseline
Spirometric measurements (FEV1/FVC ratio)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nisanur Tutuş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nisanur Tutuş, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104942
- Sponsor's protocol ID
- bronchiectasis_expiratory
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Expiratory Muscle Strength on Hospital Admission, Disease Severity and Quality of Life in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT07104942
- Acronym / sponsor ID
- bronchiectasis_expiratory
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Expiratory muscle strength
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Nisanur TutuşUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Aug 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Myopathies
- Stroke (Cerebrovascular accident - CVA)
- Pregnancy
- Unstable cardiac disease
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
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).
8 secondary outcomes
Modified Medical Research Council Dyspnea Score
Time frame: Baseline
Leicester Cough Questionnaire
Time frame: Baseline
Bronchiectasis Severity Index
Time frame: Baseline
Hospital Anxiety Depression Scale
Time frame: Baseline
Fatigue severity scale
Time frame: Baseline
Spirometric measurements (Forced vital capacity)
Time frame: Baseline
Spirometric measurements (First second forced expiratory volume)
Time frame: Baseline
Spirometric measurements (FEV1/FVC ratio)
Time frame: Baseline
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 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Bronchiectasis
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.
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, run by Nisanur Tutuş at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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 Turkey (Türkiye). 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?
Contact Nisanur Tutuş ((0216) 421 42 00 ext. 1352, nisanurtutuss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.