Cardiopulmonary Responses to 6-Minute Stepper Test in Bronchiectasis Versus Healthy Controls
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHacettepe University
About this trial
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
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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.
Being 18 years of age and older,
Trial population
Individuals with bronchiectasis and healthy controls
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
No intervention; Observational study
Other interventionNo intervention
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Bronchiectasis1 intervention
Group B: Healthy controls1 intervention
Trial outcomes
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 day2
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 day3
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 day4
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 daySecondary 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 day2
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 day3
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 day4
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Time frame
1st daySponsors and contacts
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Source ClinicalTrials.gov