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临床试验/NCT02550821
NCT02550821已完成不适用

Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects

Hacettepe University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Energy expenditure on activity monitor

研究概览

简要总结

The purpose of this study is to compare physical activity levels between patients with bronchiectasis and healthy subjects.

We hypothesize that patients with bronchiectasis will have lower levels of physical activity, since physical activity levels is affected by reduced exercise tolerance, severity of disease and other disease related symptoms and conditions.

详细描述

Physical activity limitation in chronic respiratory diseases is caused by many factors including respiratory, hemodynamic, and peripheral muscle weakness. Bronchiectasis is characterized by irreversible widening of the medium-sized airways, with inflammation, chronic bacterial infection and destruction of the bronchial walls. In addition to pulmonary function worsening, extra pulmonary features such as reduced peripheral muscle endurance can be a significant physical problem which causing a decrease in physical activity levels.

Despite physical activity is considered to be essential for the management of chronic respiratory diseases, there is a lack of scientific study, which compares physical activity levels between patients with bronchiectasis and healthy subjects.

This study will assess physical activity level, exercise capacity, quality of life and peripheral muscle strength in patients with bronchiectasis compared to healthy subjects.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria of the Bronchiectasis Group:
  • Diagnosis of bronchiectasis
  • Being 18 years of age or older
  • Able and willing to complete the informed consent process.
  • Able to walk and co-operate

排除标准

  • Exclusion criteria of Bronchiectasis Group:
  • Unstable medical condition
  • To have severe neurological, orthopedic problems or severe heart failure.
  • The control group will consist of healthy subjects.

结局指标

主要结局

Energy expenditure on activity monitor

时间窗: Seven days

Total energy expenditure will be calculated using activity monitor for seven consecutive days

Exercise capacity using 6-minute walk test and incremental shuttle walk test

时间窗: 8th day (after using device)

6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded. The incremental shuttle walk test will be performed in an enclosed corridor. Patients are required to walk back and forth, turning around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients will follow the rhythm dictated by the audio signal.

Number of steps on accelerometer

时间窗: Seven days

Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.

Physical activity level using International Physical Activity Questionnaire

时间窗: 8th day

Instrument to obtain internationally comparable data on health related physical activity This measure assesses the types of intensity of physical activity and sitting time in daily life and estimates total physical activity in MET-min/week and time spent sitting. It comprises open-ended questions surrounding individuals' last 7-day recall of physical activity.

次要结局

  • Quality of Life using St. George Respiratory Questionnaire(1st day)
  • Peripheral muscle strength test using a hand-held dynamometer(8th day (after using device))
  • Shortness of breath using the Modified Medical Research Council Dyspnea Scale(1st day (before using device))
  • Maximal inspiratory and expiratory pressures measurement using a mouthpiece device(8th day (after using device))

研究者

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

Aslihan CAKMAK

Research Assistant

Hacettepe University

研究点 (1)

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