Effects of Face Masks During Exercise

Effects of Face Coverings During Physical Activity

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Exercise; Cognitive Performance; Cardiopulmonary
• Intervention / Treatment: Other: Cardiopulmonary Exercise Test; Other: Cognitive Performance Test

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Frisco, Texas, United States, 75034
      • Baylor Scott & White Sports Therapy & Research at The Star

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No cloth face mask; 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	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; Other: Cognitive Performance Test; Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test.
Experimental: Cloth face mask; 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	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; Other: Cognitive Performance Test; Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max during cardiopulmonary exercise testing on a cycle ergometer	Exercise capacity measured by Cosmed K5 metabolic equipment	Week 1
VO2 max during cardiopulmonary exercise testing on a cycle ergometer	Exercise capacity measured by Cosmed K5 metabolic equipment	Week 2
Test duration (time) of cardiopulmonary exercise test on a cycle ergometer	Total time of test	Week 1
Test duration (time) of cardiopulmonary exercise test on a cycle ergometer	Total time of test	Week 2
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 020-353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Considered upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No