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临床试验/NCT04498546
NCT04498546已完成不适用

The Effects of Mask Usage on Exercise Capacity and Related Parameters During the COVİD-19 Pandemic

KTO Karatay University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
Recovery systolic blood pressure

研究概览

简要总结

To determine the effect of using mask during exercise on exercise capacity and values measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, severity of dyspnea, etc.). To investigate the haemodynamic effects (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, dyspnea severity, etc.) of the mask, which entered daily life during the epidemic period and which requires long-term use, and examine the effect on hemodynamic stress.

详细描述

Surgical masks are frequently used after the necessity to use a mask in the community.The effects of technologically well-designed training masks used in athletes have been shown on hypoxia and heart rate responses during exercise, but there are no studies examining the exercise capacity and hemodynamic responses given to exercise in healthy normal individuals.This study is planned to evaluate the effects of the use of surgical masks that are widespread in the community due to pandemic on the exercise capacity and exercise responses (heart rate, blood pressure, peripheral oxygen saturation, fatigue).

Exercise tests will be carried out for each individual randomly, twice with a mask and without a mask. The materials used before and after each exercise test will be sterilized. During the exercise test, individual antibacterial filters will be used for each person.Bruce protocol will be used to determine exercise capacity.

研究设计

研究类型
Observational
观察模型
Other
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
否

入选标准

  • •Volunteering to be included in the research,
  • •Being between the ages of 18-65,
  • •Having physical fitness to do exercise tests,
  • •Having a cognitive function that will allow active participation in the exercise test.
  • •No chronic illness.

排除标准

  • •Not to volunteer to participate in the research,
  • •Having any mental or physical condition that impedes performing exercise tests,
  • •Having any of the symptoms of COVID-19,
  • •Having been diagnosed with COVID-19 before,
  • •Having a history of contact with COVID-19 patient
  • •Having a cardiac, neurological, orthopedic and respiratory disease
  • •Use of assistive devices while walking

结局指标

主要结局

Recovery systolic blood pressure

时间窗: Immediately after the procedure

Recovery systolic blood pressure mmHg

Resting Heart Rate

时间窗: baseline

Resting Heart Rate beats/min

Resting systolic blood pressure

时间窗: baseline

Resting systolic blood pressure mmHg

Peripheral oxygen saturation

时间窗: Immediately after the procedure

To be measured by Pulse Oximeter (SpO2)

Recovery Heart Rate

时间窗: Immediately after the procedure

Recovery Heart Rate beats/min

Peak Heart Rate

时间窗: During the procedure

Peak Heart Rate beats/min

Resting diastolic blood pressure

时间窗: Baseline

Resting diastolic blood pressure mmHg

VO2max

时间窗: Baseline

Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.

Recovery diastolic blood pressure

时间窗: Immediately after the procedure

Recovery diastolic blood pressure mmHg

次要结局

  • Dyspnoea Severity(Immediately after the procedure)

研究者

发起方
KTO Karatay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Büşra Alkan

Research Assistant

KTO Karatay University

研究点 (1)

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