CardiopulmonaryNCT04833010
Effects of Face Masks During Exercise
A study testing Cardiopulmonary Exercise Test and Cognitive Performance Test in people with Cardiopulmonary and Exercise, run by Baylor Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary, Exercise, Cognitive Performance
- What is being tested?
- Cardiopulmonary Exercise Test and Cognitive Performance Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Sports Therapy & Research at The Star
Frisco, Texas, 75034
About this study
Official title: 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.
- Conditions
- Cardiopulmonary, Exercise, Cognitive Performance, Covid19
- Being tested
- Cardiopulmonary Exercise Test, Cognitive Performance Test
- Medical subject headings
- Motor Activity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary Exercise TestOther
Participants will complete a Cardiopulmonary Exercise test on cycle ergometer in which they will perform progressive step-exercise cycling to exhaustion
Cognitive Performance TestOther
Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Cardiopulmonary Exercise Test; Other: Cognitive Performance Test |
| 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 Receives: Other: Cardiopulmonary Exercise Test; Other: Cognitive Performance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max during cardiopulmonary exercise testing on a cycle ergometer
Exercise capacity measured by Cosmed K5 metabolic equipment
Measured: Week 1
VO2 max during cardiopulmonary exercise testing on a cycle ergometer
Exercise capacity measured by Cosmed K5 metabolic equipment
Measured: Week 2
Test duration (time) of cardiopulmonary exercise test on a cycle ergometer
Total time of test
Measured: Week 1
Test duration (time) of cardiopulmonary exercise test on a cycle ergometer
Total time of test
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Week 2
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start20 Jan 2021
- Primary completion1 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiopulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Driver, Baylor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833010
- Sponsor's protocol ID
- 020-353
- Status last verified
- Oct 2024
- First submitted
- 9 Feb 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Considered upon request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Face Coverings During Physical Activity
- ClinicalTrials.gov ID
- NCT04833010
- Acronym / sponsor ID
- 020-353
- Conditions
- Cardiopulmonary, Exercise, Cognitive Performance, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No cloth face mask | Active comparator | Other: Cardiopulmonary Exercise Test, Other: Cognitive Performance TestCross-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 | Other: Cardiopulmonary Exercise Test, Other: Cognitive Performance TestCross-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 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary Exercise TestParticipants will complete a Cardiopulmonary Exercise test on cycle ergometer in which they will perform progressive step-exercise cycling to exhaustion | Other | Cloth face mask, No cloth face mask |
| Cognitive Performance TestCognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test. | Other | Cloth face mask, No cloth face mask |
Primary outcome
VO2 max during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 1
Exercise capacity measured by Cosmed K5 metabolic equipment
VO2 max during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 2
Exercise capacity measured by Cosmed K5 metabolic equipment
Test duration (time) of cardiopulmonary exercise test on a cycle ergometer
Time frame: Week 1
Total time of test
Test duration (time) of cardiopulmonary exercise test on a cycle ergometer
Time frame: Week 2
Total time of test
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.
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.
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).
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).
8 secondary outcomes
Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 1
Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 2
Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 1
Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 2
Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 1
Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 2
Blood lactate during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 1
Blood lactate during cardiopulmonary exercise testing on a cycle ergometer
Time frame: Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Baylor Scott \& White Sports Therapy and Research at The StarLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Considered upon request.
Related trials for Cardiopulmonary
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Recruiting
Early Cardiopulmonary Rehabilitation Bundle Functional Capacity and Outcomes of Cardiac Surgeries Patients
Cardiac Surgeries
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
Not yet recruiting
A TwiCs Study of TCM Management Based on Cardiopulmonary Screening in COPD
COPD With Coronary Artery Calcificatio
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary Exercise Test and Cognitive Performance Test in people with Cardiopulmonary and Exercise, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max during cardiopulmonary exercise testing on a cycle ergometer (time frame: Week 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.