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临床试验/NCT03902236
NCT03902236Unknown不适用

Evaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis

Hacettepe University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Reaction Time and Postural Control

研究概览

简要总结

The aim of this study is to evaluate the reaction time and postural control and to investigate the relationship between reaction time, exercise capacity, muscle oxygenation and balance in children with cystic fibrosis (CF) and non-CF bronchiectasis. 40 patients including 20 CF patients and 20 non-CF bronchiectasis and 20 healthy individuals will be included in this study. Demographic and physical characteristics' will be recorded. Lung function testing will be performed. Balance will be assessed using functional reach test, exercise capacity was measured using the incremental shuttle walking test and reaction time will be assessed using ''Fitlight TrainerTM''. Heart rate, respiratory rate, oxygen saturation, muscle oxygenation, dyspnea and fatigue perception will be measured before and after exercise test and reaction time measurement.

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children diagnosed with bronchiectasis and cystic fibrosis at 6-18 years old age for the bronchiectasis and cystic fibrosis groups respectively
  • Healthy children at 6-18 years old age for the healthy group.
  • Stable medical condition (free from the acute exacerbation)
  • Children who have not participated in the planned exercise training program in the last 3 months
  • Compliance with the tests

排除标准

  • Children who have a physical problems that limit the application of the tests
  • Acute infection or unstable medical status

结局指标

主要结局

Reaction Time and Postural Control

时间窗: 8 minutes

Reaction Time and Postural Control: With bunlar Fitlight TrainerTM muş, 6 led lights placed at certain points on the wall are randomly lit and expected to extinguish them as fast as possible. In the protocol, the leds will be placed according to the physical structure of the person, and the scores of 29 LEDs will be kept in seconds. The scores will be compared cystic fibrosis, bronciechtasis and healthy groups.

Muscle oxygenation

时间窗: 40 minutes (during the incremental shuttle walk test+reaction and postural control protocol)

Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronciechtasis and healthy groups.

Exercise capacity

时间窗: 20 minutes

Exercise capacity will be assessed with incremental shuttle walk test in cystic fibrosis, bronciechtasis and healthy groups.The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases.The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends The number of shuttles is recorded. Each shuttle represents a distance of ten metres

Balance

时间窗: 5 minutes

Balance will be assessed with functional reach test in cystic fibrosis, bronciechtasis and healthy groups Functional Reach measures the maximum distance a person can reach forward, the distance of the person standing at the edge of the wall with a 90-degree shoulder flexion and the maximum distance to the front of the thumb will be noted.

次要结局

未报告次要终点

研究者

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

Jan Dik

Master of Science student

Hacettepe University

研究点 (1)

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