Effects of Face Masks During Exercise

NCT04833010 | Completed

• 1 other identifier: 020-353
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiopulmonary; Exercise; Cognitive Performance; Covid19

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer

  Week 1

• Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer

  Week 2

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

  Week 1

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

  Week 2

• Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer

  Week 1

Study Arms (2)

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

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

Other: Cardiopulmonary Exercise Test; Other: Cognitive Performance Test

Interventions

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

Cloth face mask; No cloth face mask

Cognitive Performance Test OTHER

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

Cloth face mask; No cloth face mask

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Sports Therapy & Research at The Star

Frisco, Texas, 75034, United States

Location

Related Links

• Baylor Scott \& White Sports Therapy and Research at The Star

MeSH Terms

Conditions

Motor Activity; COVID-19

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Center Director - The STAR at Frisco

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: April 6, 2021
• Study Start: January 20, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 15, 2021
• Last Updated: January 22, 2025

Record last verified: 2024-10

Locations

US (1)