Clinical trial NCT06631261: Cardiopulmonary Responses to 6-Minute Stepper Test in Bronchiectasis Versus Healthy Controls
Official title: Comparison of Cardiopulmonary Responses to 6-Minute Stepper Test Between Individuals with Bronchiectasis and Healthy Controls
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiectasis Adult
Healthy Controls Group - Age and Sex-matched
Keywords: Bronchiectasis
Exercise Capacity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with bronchiectasis and healthy controls

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.


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.

Primary outcomes:
measure: Maximal inspiratory pressure
timeFrame: 1st day
measure: Maximal expiratory pressure
timeFrame: 1st day
measure: Peripheral muscle strength
timeFrame: 1st day
measure: 6-minute stepper test responses
timeFrame: 1st day
measure: 1 minute sit-to-stand test responses
timeFrame: 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.
measure: 6-minute walk test responses
timeFrame: 1st day
Secondary outcomes:
measure: Dyspnea
timeFrame: 1st day
measure: Charlson Comorbidity Index
timeFrame: 1st day
measure: Bronchiectasis Severity Index
timeFrame: 1st day
measure: Forced vital capacity
timeFrame: 1st day
measure: Forced expiratory volume in one second
timeFrame: 1st day
measure: Forced expiratory volume in one second/forced vital capacity ratio
timeFrame: 1st day
measure: Peak expiratory flow
timeFrame: 1st day
measure: Forced mid-expiratory flow (FEF25-75)
timeFrame: 1st day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Physical Therapy and Rehabilitation
Study officials:
References: