Effects of Face Masks During Exercise

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Face Coverings During Physical Activity

Conditions
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Cardiopulmonary, Exercise, Cognitive Performance, Covid19

Intervention / Treatment
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* Other: Cardiopulmonary Exercise Test
* Other: Cognitive Performance Test


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No cloth face mask<br>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<br>* Participants will complete a Cardiopulmonary Exercise test on cycle ergometer in which they will perform progressive step-exercise cycling to exhaustion<br>Other: Cognitive Performance Test<br>* Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test.<br>|
| Experimental: Cloth face mask<br>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<br>* Participants will complete a Cardiopulmonary Exercise test on cycle ergometer in which they will perform progressive step-exercise cycling to exhaustion<br>Other: Cognitive Performance Test<br>* Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test.<br>|

What is the study measuring?
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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 |