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临床试验/NCT06631261
NCT06631261招募中不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Maximal inspiratory pressure

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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 -

排除标准

  • •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.

研究组 & 干预措施

Healthy controls

干预措施: No intervention; Observational study (Other)

Bronchiectasis

Individuals with bronchiectasis

干预措施: No intervention; Observational study (Other)

结局指标

主要结局

Maximal inspiratory pressure

时间窗: 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.

Maximal expiratory pressure

时间窗: 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.

Peripheral muscle strength

时间窗: 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.

6-minute stepper test responses

时间窗: 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.

1 minute sit-to-stand test responses

时间窗: 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

时间窗: 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.

次要结局

  • Dyspnea(1st day)
  • Forced expiratory volume in one second(1st day)
  • Forced expiratory volume in one second/forced vital capacity ratio(1st day)
  • Peak expiratory flow(1st day)
  • Forced mid-expiratory flow (FEF25-75)(1st day)
  • Charlson Comorbidity Index(1st day)
  • Bronchiectasis Severity Index(1st day)
  • Forced vital capacity(1st day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aslihan Cakmak-Onal

Principal Investigator

Hacettepe University

研究点 (1)

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