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Completed

NCT Number: NCT04833010

Effects of Face Masks During Exercise

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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Key information

Conditions

Cardiopulmonary Behavior COVID-19 Cognitive Performance Coronaviridae Infections Coronavirus Infections Covid19 Exercise Infections Lung Diseases Motor Activity Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White Sports Therapy & Research at The Star

Frisco, Texas, 75034, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Cognitive Performance Test

Other

Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test.

Primary outcomes

  1. VO2 max during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: Week 1

    Exercise capacity measured by Cosmed K5 metabolic equipment

  2. VO2 max during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: Week 2

    Exercise capacity measured by Cosmed K5 metabolic equipment

  3. Test duration (time) of cardiopulmonary exercise test on a cycle ergometer

    Time frame: Week 1

    Total time of test

  4. Test duration (time) of cardiopulmonary exercise test on a cycle ergometer

    Time frame: Week 2

    Total time of test

  5. Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer

    Time frame: Week 1

    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.

  6. Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer

    Time frame: 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.

  7. Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer

    Time frame: Week 1

    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).

  8. Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer

    Time frame: 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).

Secondary outcomes

  1. Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: Week 1

    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.

  2. Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: 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.

  3. Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: Week 1

    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

  4. Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: 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

  5. Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: Week 1

    Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer

  6. Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: Week 2

    Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer

  7. Blood lactate during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: Week 1

    Blood lactate will be measured pre and post-CPET using a Nova Medical Lactate Plus: Blood Lactate Measuring Meter-Version 2 device.

  8. Blood lactate during cardiopulmonary exercise testing on a cycle ergometer

    Time frame: Week 2

    Blood lactate will be measured pre and post-CPET using a Nova Medical Lactate Plus: Blood Lactate Measuring Meter-Version 2 device.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Effects of Face Coverings During Physical Activity

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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