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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No cloth face mask | Active Comparator | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary Exercise Test | Other | Participants will complete a Cardiopulmonary Exercise test on cycle ergometer in which they will perform progressive step-exercise cycling to exhaustion |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White Sports Therapy & Research at The Star | Frisco | Texas | 75034 | United States |
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| Label | URL |
|---|---|
| Baylor Scott \& White Sports Therapy and Research at The Star | View source |
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Considered upon request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2021 | Feb 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Cognitive Performance Test | Other | Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test. |
|
| 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 |
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 |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |