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

NCT06631261 | Recruiting

• 1 other identifier: SBA 24/793
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bronchiectasis; Exercise Capacity

Outcome Measures

Primary Outcomes (6)

• 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.

  1st day

• 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.

  1st day

• 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.

  1st day

• 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.

  1st day

• 1 minute sit-to-stand test responses

  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

  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 Outcomes (8)

• Dyspnea

  1st day

• Charlson Comorbidity Index

  1st day

• Bronchiectasis Severity Index

  1st day

• Forced vital capacity

  1st day

• Forced expiratory volume in one second

  1st day

Study Arms (2)

Bronchiectasis

Individuals with bronchiectasis

Other: No intervention; Observational study

Healthy controls

Other: No intervention; Observational study

Interventions

No intervention; Observational study OTHER

No intervention

Bronchiectasis; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with bronchiectasis and healthy controls

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.
• \- Individuals with any known internal disease and those who do not volunteer to participate in the study will not be included in the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Interventions

Observation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Aslihan Cakmak-Onal Study Principal Investigator, PhD, PT

CONTACT

+903123051576; aslihancakmak90@gmail.com

Elif Kocaaga, MSc, PT

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: September 18, 2024
• Primary Completion: January 18, 2026
• Study Completion: January 18, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)