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

Comparison of Cardiopulmonary Responses to 6-Minute Stepper Test Between Individuals With Bronchiectasis and Healthy Controls

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06631261
Enrollment
60
Registered
2024-10-08
Start date
2024-01-18
Completion date
2027-01-18
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Bronchiectasis, Exercise Capacity

Brief 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.

Interventions

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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 -

Design outcomes

Primary

MeasureTime frameDescription
Maximal inspiratory pressure1st dayMaximal 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 pressure1st dayMaximal 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 strength1st dayPeripheral 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 responses1st day6-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 responses1 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 responses1st day6-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.

Secondary

MeasureTime frameDescription
Dyspnea1st dayThe 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.
Charlson Comorbidity Index1st dayCharlson Comorbidity Index (CCI) will be used to query accompanying comorbidities. Higher CCI scores indicate a greater burden of comorbid conditions.
Bronchiectasis Severity Index1st dayBronchiectasis 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).
Forced vital capacity1st dayPulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Forced expiratory volume in one second1st dayPulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Forced expiratory volume in one second/forced vital capacity ratio1st dayPulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Peak expiratory flow1st dayPulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Forced mid-expiratory flow (FEF25-75)1st dayPulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.

Countries

Turkey (Türkiye)

Contacts

CONTACTAslihan Cakmak-Onal Study Principal Investigator, PhD, PT
aslihancakmak90@gmail.com+903123051576
CONTACTElif Kocaaga, MSc, PT

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026