Bronchiectasis AdultNCT06631261
Cardiopulmonary Responses to 6-Minute Stepper Test in Bronchiectasis Versus Healthy Controls
An observational study of Bronchiectasis Adult and Healthy Controls Group - Age and Sex-matched, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Individuals with bronchiectasis exhibit productive cough and recurrent lung infections as well as reduced exercise capacity, physical activity level, and respiratory and peripheral muscle strength. 6-minute walk test (6MWT) is often used to assess exercise capacity in chronic lung diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis Adult, Healthy Controls Group - Age and Sex-matched
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2024to 18 Jan 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with bronchiectasis and healthy controls
Bronchiectasis group - Inclusion criteria for the study:
- Being 18 years of age and older,
- Having a clinically stable bronchiectasis,
- To cooperate with the tests to be performed,
- Not having a cardiovascular disease, orthopedic or neurological problem that may affect the tests,
- Being willing to participate in the study.
Bronchiectasis group - Exclusion criteria:
- Being in an acute exacerbation period,
- Having a cardiovascular, orthopedic or neurological problem that may affect the tests,
- Not being willing to participate in the study.
Control group - Inclusion criteria for the study:
- Being 18 years of age and older,
- To cooperate with the tests to be performed,
- Not having a cardiovascular, orthopedic or neurological problem that may affect the tests,
- Being willing to participate in the study.
Control group - Exclusion criteria:
- Individuals with any known internal disease and those who do not volunteer to participate in the study will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aslihan Cakmak-Onal Study Principal Investigator, PhD, PT contact
Elif Kocaaga, MSc, PT contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
Aslihan Cakmak-Onal, PhD, PT, +903123051576, aslihancakmak90@gmail.com
Elif Kocaaga, MSc, PT
About this study
Official title: Comparison of Cardiopulmonary Responses to 6-Minute Stepper Test Between Individuals With Bronchiectasis and Healthy Controls
Individuals with bronchiectasis exhibit productive cough and recurrent lung infections as well as reduced exercise capacity, physical activity level, and respiratory and peripheral muscle strength. 6-minute walk test (6MWT) is often used to assess exercise capacity in chronic lung diseases. 6MWT is recommended to be performed along a flat corridor, at least 30 m long, with low pedestrian traffic, on a hard surface. To overcome technical limitations during 6MWT, 6-minute stepper test (6MST) has been proposed to assess exercise capacity. Another test that provides information about exercise capacity is the 1-minute sit-to-stand test (1STS). To our knowledge, there is limited information about different exercise tests including 6MST and 1STS and cardiopulmonary responses to these tests in individuals with bronchiectasis. Therefore, this study aims to compare the responses to the 6MST between individuals with bronchiectasis and healthy controls and to investigate the relationships among 6MST, 6MWT, and 1STS responses and muscle strength.
- Being tested
- No intervention; Observational study
- Keywords
- Bronchiectasis, Exercise Capacity
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; Observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Bronchiectasis | Individuals with bronchiectasis Receives: Other: No intervention; Observational study | |
| Healthy controls | Not described Receives: Other: No intervention; Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure
Maximal inspiratory pressure (MIP) and will be measured using aa mouth-piece pressure measurement device. The measurement will be repeated three times so that there will be no difference of 10 cmH₂O or 10%, and the highest value will be used for analysis.
Measured: 1st day
Maximal expiratory pressure
Maximal expiratory pressure (MEP) and will be measured using a mouth-piece pressure measurement device. The measurement will be repeated three times so that there will be no difference of 10 cmH₂O or 10%, and the highest value will be used for analysis.
Measured: 1st day
Peripheral muscle strength
Peripheral muscle strength will be assessed using a portable dynamometer. The peripheral muscle strength test will be repeated three times for the right and left sides.
Measured: 1st day
6-minute stepper test responses
6-minute stepper test will be performed, and the number of repetitions will be recorded. Cardiopulmonary responses before and after 6-minute stepper test will be recorded. 6-minute stepper test will be performed twice with 30 minutes apart.
Measured: 1st day
1 minute sit-to-stand test responses
1 minute sit-to-stand test will be performed and the repetitions will be recoded. Cardiopulmonary responses will be recorded before and after the test.
Measured: 1 minute sit-to-stand test will be performed and the repetitions will be recoded. Cardiopulmonary responses will be recorded before and after the test.
6-minute walk test responses
6-minute walk test will be performed, and the distance walked will be recorded. Cardiopulmonary responses before and after 6-minute walk test will be recorded.
Measured: 1st day
Secondary outcomes (8)
Dyspnea
The modified Medical Research Council (mMRC) dyspnea scale will be used for dyspnea assessment. The mMRC dyspnea scale is a scale in which individuals choose the expression that best describes their dyspnea level from among 5 expressions related to shortness of breath. The higher the degree, the more severe the shortness of breath.
Measured: 1st day
Charlson Comorbidity Index
Charlson Comorbidity Index (CCI) will be used to query accompanying comorbidities. Higher CCI scores indicate a greater burden of comorbid conditions.
Measured: 1st day
Bronchiectasis Severity Index
Bronchiectasis Severity Index will be used to evaluate disease severity and prognosis in bronchiectasis. It is calculated by respiratory function, age, chronic colonization with Pseudomonas aeruginosa and other bacterial infections, shortness of breath and radiological extent of the disease. Based on Bronchiectasis Severity Index, bronchiectasis severity is defined as mild (0-4), moderate (5-8) and severe (≥9).
Measured: 1st day
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Measured: 1st day
Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Measured: 1st day
Forced expiratory volume in one second/forced vital capacity ratio
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Measured: 1st day
Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Measured: 1st day
Forced mid-expiratory flow (FEF25-75)
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start18 Jan 2024
- Primary completion18 Jan 2027 (estimated)
- Study completion18 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak-Onal, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631261
- Sponsor's protocol ID
- SBA 24/793
- Status last verified
- Jun 2026
- First submitted
- 4 Oct 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiopulmonary Responses to 6-Minute Stepper Test Between Individuals With Bronchiectasis and Healthy Controls
- ClinicalTrials.gov ID
- NCT06631261
- Acronym / sponsor ID
- SBA 24/793
- Keywords
- Bronchiectasis, Exercise Capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 18 Jan 2027 (estimated)
- Study completion
- 18 Jan 2027 (estimated)
- First posted
- 8 Oct 2024 (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.
Individuals with bronchiectasis exhibit productive cough and recurrent lung infections as well as reduced exercise capacity, physical activity level, and respiratory and peripheral muscle strength. 6-minute walk test (6MWT) is often used to assess exercise capacity in chronic lung diseases. 6MWT is recommended to be performed along a flat corridor, at least 30 m long, with low pedestrian traffic, on a hard surface. To overcome technical limitations during 6MWT, 6-minute stepper test (6MST) has been proposed to assess exercise capacity. Another test that provides information about exercise capacity is the 1-minute sit-to-stand test (1STS). To our knowledge, there is limited information about different exercise tests including 6MST and 1STS and cardiopulmonary responses to these tests in individuals with bronchiectasis. Therefore, this study aims to compare the responses to the 6MST between individuals with bronchiectasis and healthy controls and to investigate the relationships among 6MST, 6MWT, and 1STS responses and muscle strength.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchiectasis | – | Other: No intervention; Observational studyIndividuals with bronchiectasis |
| Healthy controls | – | Other: No intervention; Observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with bronchiectasis and healthy controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; Observational studyNo intervention | Other | Bronchiectasis, Healthy controls |
Primary outcome
Maximal inspiratory pressure
Time frame: 1st day
Maximal inspiratory pressure (MIP) and will be measured using aa mouth-piece pressure measurement device. The measurement will be repeated three times so that there will be no difference of 10 cmH₂O or 10%, and the highest value will be used for analysis.
Maximal expiratory pressure
Time frame: 1st day
Maximal expiratory pressure (MEP) and will be measured using a mouth-piece pressure measurement device. The measurement will be repeated three times so that there will be no difference of 10 cmH₂O or 10%, and the highest value will be used for analysis.
Peripheral muscle strength
Time frame: 1st day
Peripheral muscle strength will be assessed using a portable dynamometer. The peripheral muscle strength test will be repeated three times for the right and left sides.
6-minute stepper test responses
Time frame: 1st day
6-minute stepper test will be performed, and the number of repetitions will be recorded. Cardiopulmonary responses before and after 6-minute stepper test will be recorded. 6-minute stepper test will be performed twice with 30 minutes apart.
1 minute sit-to-stand test responses
Time frame: 1 minute sit-to-stand test will be performed and the repetitions will be recoded. Cardiopulmonary responses will be recorded before and after the test.
1 minute sit-to-stand test will be performed and the repetitions will be recoded. Cardiopulmonary responses will be recorded before and after the test.
6-minute walk test responses
Time frame: 1st day
6-minute walk test will be performed, and the distance walked will be recorded. Cardiopulmonary responses before and after 6-minute walk test will be recorded.
8 secondary outcomes
Dyspnea
Time frame: 1st day
Charlson Comorbidity Index
Time frame: 1st day
Bronchiectasis Severity Index
Time frame: 1st day
Forced vital capacity
Time frame: 1st day
Forced expiratory volume in one second
Time frame: 1st day
Forced expiratory volume in one second/forced vital capacity ratio
Time frame: 1st day
Peak expiratory flow
Time frame: 1st day
Forced mid-expiratory flow (FEF25-75)
Time frame: 1st day
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 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Bronchiectasis Adult
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
RecruitingPhase 2
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingPhase 1
A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
Healthy Participants, Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 4
Azithromycin to Modify Bronchiectasis Exacerbation Risk
Non-cystic Fibrosis Bronchiectasis, Bronchiectasis Adult
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.
Aslihan Cakmak-Onal Study Principal Investigator, PhD, PT contact
Elif Kocaaga, MSc, PT contact
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 and Healthy Controls Group - Age and Sex-matched, run by Hacettepe University 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?
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 25 Jun 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 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 Aslihan Cakmak-Onal Study Principal Investigator, PhD, PT (+903123051576, aslihancakmak90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (time frame: 1st day). The study lists 6 primary outcomes in all. 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 25 Jun 2026.