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

June 24, 2026 updated by: Aslihan Cakmak-Onal, Hacettepe University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aslihan Cakmak-Onal Study Principal Investigator, PhD, PT
  • Phone Number: +903123051576
  • Email: aslihancakmak90@gmail.com

Study Contact Backup

  • Name: Elif Kocaaga, MSc, PT

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation
        • Principal Investigator:
          • Aslihan Cakmak-Onal, PhD, PT
        • Sub-Investigator:
          • Elif Kocaaga, MSc, PT
        • Sub-Investigator:
          • Deniz Inal-Ince, PhD, PT
        • Contact:
          • Elif Kocaaga, MSc, PT
        • Contact:
        • Sub-Investigator:
          • Naciye Vardar-Yagli, PhD, PT
        • Sub-Investigator:
          • Ziya Toros Selcuk, MD
        • Sub-Investigator:
          • Melda Saglam, PhD, PT
        • Sub-Investigator:
          • Ebru Calik-Kutukcu, PhD, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals with bronchiectasis and healthy controls

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Other: No intervention; Observational study
No intervention
Bronchiectasis
Individuals with bronchiectasis
Other: No intervention; Observational study
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1st day
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.
1st day
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.
1st day
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.
1st day
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.
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.
1st day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced vital capacity
Time Frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
1st day
Forced expiratory volume in one second
Time Frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
1st day
Peak expiratory flow
Time Frame: 1st day
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
1st day
Forced mid-expiratory flow (FEF25-75)
Time Frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
1st day
Dyspnea
Time Frame: 1st day
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.
1st day
Charlson Comorbidity Index
Time Frame: 1st day
Charlson Comorbidity Index (CCI) will be used to query accompanying comorbidities. Higher CCI scores indicate a greater burden of comorbid conditions.
1st day
Bronchiectasis Severity Index
Time Frame: 1st day
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).
1st day
Forced expiratory volume in one second/forced vital capacity ratio
Time Frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
1st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

January 18, 2027

Study Completion (Estimated)

January 18, 2027

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBA 24/793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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