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RecruitingNCT06631261Updated Jun 25, 2026

Cardiopulmonary Responses to 6-Minute Stepper Test in Bronchiectasis Versus Healthy Controls

An observational study in Bronchiectasis Adult and Healthy Controls Group - Age and Sex-matched, sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Hacettepe University · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Bronchiectasis Adult
  • Healthy Controls Group - Age and Sex-matched

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Keywords

  • Bronchiectasis
  • Exercise Capacity
03

In context

Bronchiectasis

404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.

This study's planned enrollment of 60 is below the median of 160 across 137 observational studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Individuals with bronchiectasis and healthy controls

Eligibility criteria

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.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Bronchiectasis

    Individuals with bronchiectasis

    Other: No intervention; Observational study

  • Healthy controls

    Other: No intervention; Observational study

Interventions

  • OtherNo intervention; Observational study

    No intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1st day

  2. 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.

    Time frame: 1st day

  3. 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.

    Time frame: 1st day

  4. 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.

    Time frame: 1st day

  5. 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.

    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.

  6. 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.

    Time frame: 1st day

Secondary outcomes

  1. 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.

    Time frame: 1st day

  2. Charlson Comorbidity Index

    Charlson Comorbidity Index (CCI) will be used to query accompanying comorbidities. Higher CCI scores indicate a greater burden of comorbid conditions.

    Time frame: 1st day

  3. 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).

    Time frame: 1st day

  4. Forced vital capacity

    Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.

    Time frame: 1st day

  5. Forced expiratory volume in one second

    Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.

    Time frame: 1st day

  6. 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.

    Time frame: 1st day

  7. Peak expiratory flow

    Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.

    Time frame: 1st day

  8. Forced mid-expiratory flow (FEF25-75)

    Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.

    Time frame: 1st day

07

Study locations

1 of 1 sites recruiting
  • Hacettepe University Faculty of Physical Therapy and Rehabilitation
    Ankara, 06100, Turkey (Türkiye)
    Recruiting
    • Aslihan Cakmak-Onal, PhD, PT · Contactaslihancakmak90@gmail.com · +903123051576
    • Elif Kocaaga, MSc, PT · Contact
    • Aslihan Cakmak-Onal, PhD, PT · Principal investigator
    • Naciye Vardar-Yagli, PhD, PT · Sub investigator
    • Ziya Toros Selcuk, MD · Sub investigator
    • Deniz Inal-Ince, PhD, PT · Sub investigator
    • Melda Saglam, PhD, PT · Sub investigator
    • Ebru Calik-Kutukcu, PhD, PT · Sub investigator
    • Elif Kocaaga, MSc, PT · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06631261
Responsible party
Aslihan Cakmak-Onal (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Oct 8, 2024
Start date
Jan 18, 2024
Primary completion
Jan 18, 2027 (estimated)
Completion
Jan 18, 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Aslihan Cakmak-Onal Study Principal Investigator, PhD, PT
Contact
aslihancakmak90@gmail.com
+903123051576
Elif Kocaaga, MSc, PT
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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