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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04833010
Other study ID # 020-353
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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