Mask Usage and Exercise During the COVİD-19 Pandemic

Completed

• Conditions: Exercise Test

• Registration Number: NCT04498546
• Lead Sponsor: KTO Karatay University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-07-20
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-04
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resting Heart Rate	baseline	Resting Heart Rate beats/min
Resting systolic blood pressure	baseline	Resting systolic blood pressure mmHg
Recovery systolic blood pressure	Immediately after the procedure	Recovery systolic blood pressure mmHg
Peripheral oxygen saturation	Immediately after the procedure	To be measured by Pulse Oximeter (SpO2)
Peak Heart Rate	During the procedure	Peak Heart Rate beats/min
Resting diastolic blood pressure	Baseline	Resting diastolic blood pressure mmHg
VO2max	Baseline	Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.
Recovery diastolic blood pressure	Immediately after the procedure	Recovery diastolic blood pressure mmHg
Recovery Heart Rate	Immediately after the procedure	Recovery Heart Rate beats/min

Secondary Outcome Measures

Name	Time	Method
Dyspnoea Severity	Immediately after the procedure	It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases

Trial Locations

Locations (1)

KTO Karatay University; 🇹🇷 Konya, Karatay, Turkey