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临床试验/NCT07032740
NCT07032740已完成不适用

Respiratory Pattern Change in Runners by Respiratory Tract Restriction Using a Respirator

University of South Bohemia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Breathing pattern with and without using a respirator

研究概览

简要总结

This study involves 20 race runners (10 girls and 10 boys) aged 16-26. The investigators looked at the effect of the respirator on their respiratory function and the involvement of individual breath sectors. The order of the tests was randomly divided, each taking a test with and without a respirator.

详细描述

Participants in this study were race runners. The inclusion criteria required participants to be between 16 and 26 years of age, free from any injuries, and able to provide full written informed consent. Exclusion criteria included smoking or the presence of any chronic pulmonary or cardiac disease, ensuring that the study focused solely on a healthy, homogenous population of physically active individuals.

Ethical Approval Prior to the measurements, all participants signed an informed consent form. The research was carried out with the consent of the Ethics Committee, Faculty of Education, University of South Bohemia, Ref. No.: EK031/2023. All procedures performed in the study were in accordance with the ethical standards of the institutional research committee and with the Helsinki declaration.

Measures, Design and Procedures Participants visited the laboratory twice to complete GXT (graded exercise tests) with the use of OEP (pto-electronic plethysmography). The time period between testing days was 72 hours. Participants were randomly (randomizer.org) split into two groups. The first group performed tests using FFR and the second without the mask. On the second visit, participants crossed over to the other condition. The N95 respirator (Promedor24, Czech Republic) was used for the study as a gold standard in protecting against aerosol transfer during the COVID-19 pandemic. New masks were used for each test. During GXT, data from OEP were collected from the last minute of each three minute stage.

Opto-electronic plethysmography An analysis of the breathing pattern and chest wall compartment volumes was performed using opto-electronic plethysmography (BTS Bioengineering, Milan, Italy). The system involves eight cameras (five positioned anterior and three posterior to the participant) and 89 reflective markers which were placed on the subject's chest, abdomen and back in order to map the subject's trunk. This technique has been shown to be valid at rest and during maximal exercise.

The contributions of each breathing compartment (VRCp- pulmonary rib cage, VRCa- abdominal rib cage, VAb- abdomen) were determined using the difference between end-inspiratory and end-expiratory volume. The exact method of calculating chest wall kinematics with OEP has been described in prior work.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

After enrollment in the study (in a pre-selected order of tests), participants were assigned a number under which they passed the tests.

入排标准

年龄范围
16 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •regular running training at least six times a week
  • •full limit for national championship

排除标准

  • •presence of any chronic pulmonary or cardiac d

研究组 & 干预措施

With respirator

Experimental

The group of runners performed a test with a respirator.

干预措施: Bruce test (Diagnostic Test)

Without respirator

Active Comparator

The group runners performed a test without a respirator.

干预措施: Bruce test (Diagnostic Test)

结局指标

主要结局

Breathing pattern with and without using a respirator

时间窗: Day 1 - first test, day 4 (after 72 hours) - second test

Respiratory sector involvement ratio during Bruce test with using a respirator and without using a respirator

次要结局

未报告次要终点

研究者

发起方
University of South Bohemia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petr Bahensky

Head of Laboratory

University of South Bohemia

研究点 (2)

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