Effects of Face Masks During Exercise

Covid19 Clinical Trial

Official title:

Effects of Face Coverings During Physical Activity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04833010
• Other study ID #: 020-353
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To describe the primary and secondary outcomes of athletes during a Cardiopulmonary Exercise Test (CPET) on a cycle ergometer with and without a face mask.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Be able to come to Baylor Scott & White Sports Therapy and Research at The Star in Frisco, Texas twice in three weeks.
• Be willing to wear a face mask during exercise capacity testing on a stationary bicycle. Exclusion Criteria: -

Related Conditions & MeSH terms

• Cardiopulmonary
• Cognitive Performance
• Covid19
• Exercise

Intervention

Other:
• Cardiopulmonary Exercise Test
Participants will complete a Cardiopulmonary Exercise test on cycle ergometer in which they will perform progressive step-exercise cycling to exhaustion
• Cognitive Performance Test
Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test.

Locations

Country	Name	City	State
United States	Baylor Scott & White Sports Therapy & Research at The Star	Frisco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 max during cardiopulmonary exercise testing on a cycle ergometer	Exercise capacity measured by Cosmed K5 metabolic equipment	Week 1
Primary	VO2 max during cardiopulmonary exercise testing on a cycle ergometer	Exercise capacity measured by Cosmed K5 metabolic equipment	Week 2
Primary	Test duration (time) of cardiopulmonary exercise test on a cycle ergometer	Total time of test	Week 1
Primary	Test duration (time) of cardiopulmonary exercise test on a cycle ergometer	Total time of test	Week 2
Primary	Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer	Cognitive testing will take place at the end of each stage of the CPET. Cognitive testing using the SACL Cognition application on iPad will include a baseline SRT measurement and additional measurements at the end of each stage of the CPET. The baseline will include a 30s session of SRT for familiarization and then a 30s session will be scored. SRT will then be administered for 30s at the end of each stage of the CPET. The SRT task includes a visual stimulus presented on the touchscreen. Subjects will be instructed to press the stimulus on-screen as quickly as possible. Reaction time will be measured on the SRT task. Reaction time is calculated as the average amount of time in seconds between stimulus presentation and user response within a session.	Week 1
Primary	Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer	Cognitive testing will take place at the end of each stage of the CPET. Cognitive testing using the SACL Cognition application on iPad will include a baseline SRT measurement and additional measurements at the end of each stage of the CPET. The baseline will include a 30s session of SRT for familiarization and then a 30s session will be scored. SRT will then be administered for 30s at the end of each stage of the CPET. The SRT task includes a visual stimulus presented on the touchscreen. Subjects will be instructed to press the stimulus on-screen as quickly as possible. Reaction time will be measured on the SRT task. Reaction time is calculated as the average amount of time in seconds between stimulus presentation and user response within a session.	Week 2
Primary	Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer	Cognitive testing will take place at the end of each stage of the CPET. Cognitive testing using the SACL Cognition application on iPad will include a baseline SRT measurement and additional measurements at the end of each stage of the CPET. The baseline will include a 30s session of SRT for familiarization and then a 30s session will be scored. SRT will then be administered for 30s at the end of each stage of the CPET. The SRT task includes a visual stimulus presented on the touchscreen. Subjects will be instructed to press the stimulus on-screen as quickly as possible. Accuracy will be measured on the SRT task. Accuracy is calculated as the total number of correct responses to stimuli divided by the total number of stimuli presented during a session (presented as a percentage).	Week 1
Primary	Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer	Cognitive testing will take place at the end of each stage of the CPET. Cognitive testing using the SACL Cognition application on iPad will include a baseline SRT measurement and additional measurements at the end of each stage of the CPET. The baseline will include a 30s session of SRT for familiarization and then a 30s session will be scored. SRT will then be administered for 30s at the end of each stage of the CPET. The SRT task includes a visual stimulus presented on the touchscreen. Subjects will be instructed to press the stimulus on-screen as quickly as possible. Accuracy will be measured on the SRT task. Accuracy is calculated as the total number of correct responses to stimuli divided by the total number of stimuli presented during a session (presented as a percentage).	Week 2
Secondary	Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer	The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during cardiopulmonary exercise test on a cycle ergometer.	Week 1
Secondary	Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer	The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during cardiopulmonary exercise test on a cycle ergometer.	Week 2
Secondary	Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer	The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during cardiopulmonary exercise test on a cycle ergometer	Week 1
Secondary	Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer	The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during cardiopulmonary exercise test on a cycle ergometer	Week 2
Secondary	Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer	Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer	Week 1
Secondary	Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer	Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer	Week 2
Secondary	Blood lactate during cardiopulmonary exercise testing on a cycle ergometer	Blood lactate will be measured pre and post-CPET using a Nova Medical Lactate Plus: Blood Lactate Measuring Meter-Version 2 device.	Week 1
Secondary	Blood lactate during cardiopulmonary exercise testing on a cycle ergometer	Blood lactate will be measured pre and post-CPET using a Nova Medical Lactate Plus: Blood Lactate Measuring Meter-Version 2 device.	Week 2

External Links

•   Baylor Scott & White Sports Therapy and Research at The Star