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NCT Number: NCT06631261

Cardiopulmonary Responses to 6-Minute Stepper Test in Bronchiectasis Versus 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Aslihan Cakmak-Onal, PhD, PT

CONTACT

[email protected]

+903123051576

Aslihan Cakmak-Onal, PhD, PT

PRINCIPAL_INVESTIGATOR

Deniz Inal-Ince, PhD, PT

SUB_INVESTIGATOR

Ebru Calik-Kutukcu, PhD, PT

SUB_INVESTIGATOR

Elif Kocaaga, MSc, PT

CONTACT

Elif Kocaaga, MSc, PT

SUB_INVESTIGATOR

Melda Saglam, PhD, PT

SUB_INVESTIGATOR

Naciye Vardar-Yagli, PhD, PT

SUB_INVESTIGATOR

Ziya Toros Selcuk, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention; Observational study

Other

No intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. Forced vital capacity

    Time frame: 1st day

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

  5. 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.

  6. 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.

  7. Peak expiratory flow

    Time frame: 1st day

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

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslihan Cakmak-Onal Study Principal Investigator, PhD, PT

CONTACT

[email protected]

+903123051576

Elif Kocaaga, MSc, PT

CONTACT

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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