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临床试验/NCT05712798
NCT05712798已完成不适用

Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Children and Investigation of the Relationship Between Exercise Capacity and Quality of Life in Primary Ciliary Dyskinesia

Hacettepe University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Maximal oxygen uptake

研究概览

简要总结

The individuals with primary ciliary dyskinesia (PCD) have lower aerobic fitness and anaerobic performance than healthy individuals. Cardiopulmonary exercise test (CPET) provides an integrated assessment of integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems that are not adequately reflected by measurement of the function of organ systems. Maximum oxygen consumption is measured by performing gas exchange analysis with CPET, offering an objective measure of cardiorespiratory fitness. The six-minute walk test (6MWT) and the shuttle walk test (SWT) are field tests that produce oxygen consumption results similar to those during CPET. There is a need to determine the physiological responses to CPET, SWT and 6MWT in individuals with PCD. Additionally, the physiological responses of individuals with PCD to different exercise tests will be compared with the responses of healthy individuals. Low aerobic capacity in individuals with PCD may affect the physical, emotional, and social lives of individuals. This influence may cause a decrease in the quality of life of individuals with PCD. The relationship between exercise capacity and quality of life in individuals with PSD will be investigated with this study.

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

入选标准

  • Having been diagnosed with PCD in the Pediatrics Department, Pediatric Chest Diseases Unit of Hacettepe University Faculty of Medicine and being routinely referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit for physiotherapy applications and pulmonary rehabilitation program,
  • Being clinically stable,
  • Being between 8-18 years old,
  • Having a forced expiratory volume in the first second (FEV1) ≥ 40%,
  • The healthy group will be composed of individuals who do not have any known disease and volunteer to participate in the study. For healthy individuals, volunteers from acquaintances and/or relatives of the researchers will be included in the study.

排除标准

  • Having unstable clinical condition
  • Having severe neuromuscular and musculoskeletal problems,
  • Having any congenital heart diseases other than situs inversus,
  • Unable to cooperate

结局指标

主要结局

Maximal oxygen uptake

时间窗: up to 3 weeks

Maximal oxygen uptake will be determined using cardiopulmonary exercise test.

6 minute walk test distance

时间窗: up to 3 weeks

6 minute walk test distance will be determined using 6 minute walk test

Quality of life score

时间窗: 1st day

Quality of life score will be determined using multidimensional measure to assess health-related quality of life in primary ciliary dyskinesia (QoL-PCD).

Shuttle walk test distance

时间窗: up to 3 weeks

Shuttle walk test distance will be determined using shuttle walk test

次要结局

  • Pulmonary function test - forced vital capacity(1st day)
  • Pulmonary function test - Forced expiratory volume in one second(1st day)
  • Pulmonary function test - Peak expiratory flow(1st day)
  • Maximal expiratory pressure(1st day)
  • Maximal inspiratory pressure(1st day)
  • Pulmonary function test - Forced mid-expiratory flow (FEF25-75)(1stday)

研究者

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

Aslihan Cakmak

Principal Investigator

Hacettepe University

研究点 (1)

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