Mask Usage and Exercise During the COVİD-19 Pandemic

Exercise Test Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498546
• Other study ID #: KaratayU3
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: April 2022
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Exercise Test

Locations

Country	Name	City	State
Turkey	KTO Karatay University	Konya	Karatay

Sponsors (1)

Lead Sponsor	Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Heart Rate	Resting Heart Rate beats/min	baseline
Primary	Peak Heart Rate	Peak Heart Rate beats/min	During the procedure
Primary	Recovery Heart Rate	Recovery Heart Rate beats/min	Immediately after the procedure
Primary	Resting systolic blood pressure	Resting systolic blood pressure mmHg	baseline
Primary	Recovery systolic blood pressure	Recovery systolic blood pressure mmHg	Immediately after the procedure
Primary	Resting diastolic blood pressure	Resting diastolic blood pressure mmHg	Baseline
Primary	Recovery diastolic blood pressure	Recovery diastolic blood pressure mmHg	Immediately after the procedure
Primary	Peripheral oxygen saturation	To be measured by Pulse Oximeter (SpO2) To be measured by Pulse Oximeter (SpO2)	Baseline
Primary	Peripheral oxygen saturation	To be measured by Pulse Oximeter (SpO2)	Immediately after the procedure
Primary	VO2max	Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.	Baseline
Secondary	Dyspnoea Severity	It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases	Baseline
Secondary	Dyspnoea Severity	It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases	Immediately after the procedure