Effects of Face Masks During Exercise

Not Applicable

Completed

• Conditions: Cardiopulmonary; Covid19; Exercise; Cognitive Performance
• Interventions: Other: Cardiopulmonary Exercise Test; Other: Cognitive Performance Test

• Registration Number: NCT04833010
• Lead Sponsor: Baylor Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-06
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-15
• Status Verified: 2024-10
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No cloth face mask	Cardiopulmonary Exercise Test	Cross-over randomization. Participants randomized to this arm will not wear a cloth face mask for Test 1 which they do a progressive step-exercise cycling test to exhaustion
Cloth face mask	Cognitive Performance Test	Cross-over randomization. Participants randomized to this arm will wear a cloth face mask for Test 1 which they do a progressive step-exercise cycling test to exhaustion
Cloth face mask	Cardiopulmonary Exercise Test	Cross-over randomization. Participants randomized to this arm will wear a cloth face mask for Test 1 which they do a progressive step-exercise cycling test to exhaustion
No cloth face mask	Cognitive Performance Test	Cross-over randomization. Participants randomized to this arm will not wear a cloth face mask for Test 1 which they do a progressive step-exercise cycling test to exhaustion

Primary Outcome Measures

Name	Time	Method
Test duration (time) of cardiopulmonary exercise test on a cycle ergometer	Week 2	Total time of test
Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer	Week 2	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).
Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer	Week 2	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.
VO2 max during cardiopulmonary exercise testing on a cycle ergometer	Week 2	Exercise capacity measured by Cosmed K5 metabolic equipment

Secondary Outcome Measures

Name	Time	Method
Blood lactate during cardiopulmonary exercise testing on a cycle ergometer	Week 2	Blood lactate will be measured pre and post-CPET using a Nova Medical Lactate Plus: Blood Lactate Measuring Meter-Version 2 device.
Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer	Week 2	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
Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer	Week 2	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.
Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer	Week 2	Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer

Trial Locations

Locations (1)

Baylor Scott & White Sports Therapy & Research at The Star; 🇺🇸 Frisco, Texas, United States