HypoxemiaNCT05143801
"Facemask Use During High-intensity Interval Exercise in Temperate and Hot Environments"
A study testing High-intensity interval exercise with surgical face mask in a temperate environment, High-intensity interval exercise with surgical face mask in a hot environment and High-intensity interval exercise without using a surgical face mask in a hot environment in people with Hypoxemia and Physiological Stress, run by University of New Mexico at 1 site in United States.
Trial summary
To investigate surgical mask use and high-intensity interval exercise across different environmental conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia, Physiological Stress
- What is being tested?
- High-intensity interval exercise with surgical face mask in a temperate environment, High-intensity interval exercise with surgical face mask in a hot environment and High-intensity interval exercise without using a surgical face mask in a hot environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older and, are able to both speak and read in English.
- Physically active and used to high-intensity exercise.
- No known serious medical conditions.
Who cannot join
- Vulnerable populations such as children, minors, pregnant women, and intellectually challenged individuals.
- Those with cardiovascular, renal, metabolic, or chronic respiratory disease, smokers or those who have quit smoking less than 6 months ago, and those who use an inhaler to control for exercise-induced asthma.
- In addition, exclusion criteria include participants who show any signs or symptoms of COVID-19 and have had exposure to anyone with COVID-19 symptoms or any person that has tested positive for COVID-19.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
To investigate surgical mask use and high-intensity interval exercise across different environmental conditions.
Read the detailed description
Mask use in public settings is recommended to limit the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the disease known as COVID-19 and endorsed by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Wearing a mask during exercise may have implications for recreational exercisers and athletes that train and compete at a high exercise intensities as it has been shown to limit ventilation (VE) and increase end-tidal CO2 compared to a no-mask control. For example, N95 masks are designed to fit more tightly around the nose and mouth than other types of masks and have been shown to reduce markers of maximal exercise performance compared to a no-mask control for individuals performing an incremental ramp protocol on a cycle ergometer.
In contrast to N95 masks being reserved for health care workers, surgical masks certified by National Institute for Occupational Safety and Health are easily accessible to wear during exercise to reduce the risk of COVID-19 spread. Indeed, these masks fit more loosely than the N95, but did not reduce maximal power (Pmax), relative oxygen consumption (mL/kg/min), or test duration in two studies where participants performed a progressive maximal exercise test on a cycle ergometer. Further, surgical mask use during a progressive maximal cycling exercise protocol did not change cardiovascular, metabolic, and pulmonary measurements when compared to a no-mask condition in healthy individuals, with the exception of a decrease in maximal heart rate (HRmax). Another recent study using a progressive maximal cycling exercise protocol showed no change in (HRmax) using cycle ergometry when surgical mask use was compared to a no-mask condition. While this type of progressive maximal exercise test is frequently used for clinical and laboratory settings to assess cardiovascular, pulmonary, and metabolic markers, this type of exercise protocol is not often employed by athletes seeking to improve performance or recreational exercisers taking action to improve fitness. Because this exercise protocol is not used by athletes or recreational exercisers to train, it is difficult to translate the results of mask use during progressive maximal exercise tests to commonly practiced forms of exercise. In fact, a recent meta-analysis concludes that wearing a mask elicits a minimal impact on cardiovascular, respiratory, or metabolic variables across a wide array of exercise intensities and modalities, however, high intensity interval exercise (HIIE) was not included in this analysis, nor were hot environmental temperatures. Thus, the physiologic or metabolic responses while wearing a medical-grade surgical mask are not yet known with HIIE in both temperate and hot environments.
High intensity interval exercise is a popular time-efficient training method that involves short high intensity bouts followed by either active (low/moderate intensity exercise) or passive (no exercise) rest bouts. High intensity interval exercise has been shown to be a safe and effective way to increase physical fitness or performance in a diverse population that include exercisers in recreational, competitive, and clinical settings. Further, as HIIE can be performed in either an indoor or outdoor environment and using a mask may increase the physiological and perceptual strain of the exercise depending on the temperature and humidity. In a hot environment (40°C and 20% humidity), no difference was found in skin temperature under or outside a KN95 mask in healthy males that performed 45-minutes of moderate intensity physical activity that mimicked movements required in occupational settings. Also, no difference was found in whole body thermal discomfort, and an increase in perceived breathlessness by 36% was observed. In addition, surgical mask use during 30 minutes of mild uphill treadmill exercise did not increase risk of heat stroke in a hot and humid environment. To date, no research study has investigated the effects of surgical mask use during HIIE in different environmental conditions.
Therefore, the purpose of this study was to investigate the effects of surgical mask use during HIIE on cardiovascular, metabolic, thermoregulatory, and perceptual responses in temperate and hot environments.
Methodsː In a randomized fashion, ten healthy participants completed two HIIE sessions in a 36°C hot (HIIE-HOT) and two HIIE sessions in a 23°C temperate environment (HIIE-TEMP) while wearing (MASK) and not wearing a surgical mask (CON).
Procedures Anthropometrics and maximal Oxygen uptake measurements Before the experimental trials, participants visited the Exercise Physiology laboratories for anthropometrics and VO2max measurement. Body height was measured using a stadiometer (SECA, seca 216, Chino, CA, USA) and weight was measured using a digital scale (Cardinal DETECTO 758C, Webb City, MO). Then, participants completed a 5-minute warm-up at a self-selected exercise intensity prior to the VO2max test on an electrically braked cycle ergometer (Lode, Excalibur Sport, Groningen, The Netherlands). During the VO2max test, HR was measured using a Polar HR monitor (Polar, Polar H10, USA) with each test designed to last between 10 and 12 minutes. The starting resistance and the continuous increase in resistance (between 20-40 watts) throughout the test was based on the participants' self-reported fitness. Termination of the VO2max test occurred at volitional fatigue or when the participant could no longer maintain a cycling cadence of 60 revolutions per minute or higher. Gas-exchange was measured using a metabolic analyzer (Parvo Medics Inc, TrueOne 2400, Salt Lake City, UT) and data were analyzed using an 11-breath rolling average20. Primary criteria for a VO2max was categorized as an observed plateau that varied by less than 150 mlO2/min21. To determine a plateau using primary criteria, the mean of the absolute difference from each neighboring data point in the last 30 seconds of the 11-breath rolling average VO2 was compared against 150 mlO2/min21; if the average value was smaller, the test was categorized as a VO2max. In the absence of a plateau, a VO2max was confirmed if two of the three secondary criteria were met: 1) an RPE ≥17, 2) a respiratory exchange ratio (RER) of 1.1 or greater, and 3) a HR within 10 beats of estimated heart rate max using the Jones et al. equation (202 - 0.72 x age). The highest power output recorded from the VO2max test was used to calculate the high intensity and active recovery bouts for the HIIE sessions.
High Intensity Interval Exercise Trials Before all HIIE sessions participant's hydration status was assessed measuring urine specific gravity (USG) using a handheld refractometer (Cole-Parmer, RSA-BR90A, Vernon Hills, IL). A USG measurement lower than 1.020 g/cc allowed participants to proceed to the HIIE sessions. If USG was greater than 1.020 g/cc, then participants consumed 500 ml of water, and were reassessed after 30 minutes. This water provision was only repeated twice if USG remained above 1.020 g/cc.
A randomized cross over repeated measures design was used to compare cardiovascular, thermoregulatory, metabolic, and perceived responses before and during HIIE across four experimental trials performed during two visits. For each visit, which was separated by a minimum of 72 hours, the participants completed two HIIE sessions separated by 3 hours of rest. Each HIIE bout consisted of 10 bouts lasting 30 seconds performed at 85% Pmax followed by 90 seconds of active recovery at 30% Pmax. The HIIE sessions were performed in a temperate environment (23°C, 25% relative humidity) with (TEMP/MASK) and without a surgical mask (TEMP/CON), and in a hot environment (36°C, 14% relative humidity) with (HOT/MASK) and without a surgical mask (HOT/CON). During the exercise protocol participants were allowed to drink water.
During HIIE sessions with a mask, all participants were instructed to wear the surgical mask snugly over their nose and mouth. The participants fitted the flexible metal plate within the surgical mask over the bridge of the nose and had the bottom of the mask cover underneath the chin. During the 3-hour rest period participants were provided a 350-calorie meal (7g of Fat; 64g Carbohydrate; 9g Protein) and water ad libitum.
Cardiovascular Measurements Before every HIIE trial and after 5-minutes of seated rest, resting blood pressure was measured using a sphygmomanometer, and stethoscope. A cardiac impedance device (PhysioFlow®, NeuMeDex, Bristol, PA) calibrated per manufacturer guidelines was used to indirectly measure cardiac output (CO), stroke volume (SV), and HR. These measurements were taken continuously using 10-second averaging provided by the PhysioFlow® software during each HIIE session.
Metabolic Measurements A near infra-red spectroscopy (NIRS) device (Moxy, Moxy Monitor System, MN, USA) was used to measure muscle tissue oxygenation every second during each HIIE session. The highest muscle tissue oxygenation value from each active rest period (MTO active rest %) was averaged for each HIIE session. Additionally, the lowest muscle tissue oxygenation (MTO during HIIE %) value per high intensity bout was recorded and averaged from each HIIE session. The difference of the average MTO active rest % and MTO during HIIE % was used to calculate the muscle tissue oxygenation difference (MTO difference %). All MTO measurements were taken on the dominant leg at a marked location on the vastus lateralis that would allow movement without interference from the NIRS device. A pulse oximeter (Caretaker, Caretaker Medical, USA) was used to measure SpO2 during HIIE. Blood lactate measurements (Lactate Plus, NOVA Biomedical, MA) were taken in duplicate at the ear lobe immediately before, and 5-minutes post HIIE.
Perceptual Measurement before and during HIIE Borg's rating of perceived exertion (6 rest to 20 maximal effort) scale (RPE) and thermal sensation (0 very cold to 8 very hot) was measured immediately before and every four minutes into HIIE. A breathlessness scale (0 mm no breathlessness to 200 mm maximal breathlessness)was used immediately before, at 10-minutes, and immediately after exercise to record subjective change in difficulty breathing. The highest measurements for both RPE (peak RPE) and thermal sensation (peak thermal sensation) were recorded per HIIE session performed. Additionally, RPE (RPE avg) and dyspnea scores were averaged over time for every HIIE session.
Thermal strain and hydration measurements During each HIIE exercise session continuous core temperature measurements were taken using rectal thermistors (Level 1 esophageal/rectal temperature probe, Smiths Medical, Minneapolis, MN, USA) connected to a thermometer (Precision 4000, YSI Incorporated, Yellow Springs, OH, USA) and monitored to ensure participant safety. Additionally, ∆ core temperature (i.e., the difference between peak core temperature and core temperature prior to starting exercise) and peak core temperature were recorded for each HIIE session. Sweat rate and dehydration were calculated from pre-exercise nude weight, post-exercise nude weight, water ingestion, and post-exercise urine output measurements27. Participants were asked to measure and report their pre-exercise and post-exercise nude weight using a digital scale (Cardinal DETECTO 758C, Webb City, MO) in a private room.
- Conditions
- Hypoxemia, Physiological Stress
- Being tested
- High-intensity interval exercise with surgical face mask in a temperate environment, High-intensity interval exercise with surgical face mask in a hot environment, High-intensity interval exercise without using a surgical face mask in a hot environment, High-intensity interval exercise without using a surgical face mask in a temperate environment
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval exercise with surgical face mask in a temperate environmentDevice
Participants performed high-intensity interval exercise in a temperate environmental condition while wearing surgical face mask
High-intensity interval exercise with surgical face mask in a hot environmentDevice
Participants performed high-intensity interval exercise in a hot environmental condition while wearing surgical face mask
High-intensity interval exercise without using a surgical face mask in a hot environmentOther
Participants performed high-intensity interval exercise in a hot environmental condition without wearing a surgical face mask
High-intensity interval exercise without using a surgical face mask in a temperate environmentOther
Participants performed high-intensity interval exercise in a temperate environmental condition without wearing a surgical face mask
| Study group | Role | What they receive |
|---|---|---|
| No mask temperate | Active comparator | Participant exercised in room temperature environment not wearing a surgical face mask Receives: Other: High-intensity interval exercise without using a surgical face mask in a temperate environment |
| Mask temperate | Experimental | Participant exercised in room temperature environment while wearing a surgical face mask Receives: Device: High-intensity interval exercise with surgical face mask in a temperate environment |
| No mask hot | Active comparator | Participant exercised in a hot environmental temperature not wearing a surgical face mask Receives: Other: High-intensity interval exercise without using a surgical face mask in a hot environment |
| Mask hot | Experimental | Participant exercised in a hot environmental temperature while wearing a surgical face mask Receives: Device: High-intensity interval exercise with surgical face mask in a hot environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Heart Rate Over the Course of High-intensity Interval Exercise
Heart rate measured in beats per minute using a cardiograph impedance device (PhysioFlow)
Measured: During a 20-minute high-intensity interval exercise session
Average Stroke Volume Over the Course of High-intensity Interval Exercise
Stroke volume measured in milliliters using a cardiograph impedance device (PhysioFlow)
Measured: During a 20-minute high-intensity interval exercise session
Average Cardiac Output Over the Course of High-intensity Interval Exercise
Cardiac output measured in liters per minute using a cardiograph impedance device (PhysioFlow)
Measured: During a 20-minute high-intensity interval exercise session
Peak Core Temperature
The highest core body temperature measured in degrees Celsius during high-intensity interval exercise
Measured: The highest value recorded during a 20-minute high-intensity interval exercise session
Change From Baseline (Rest) in Core Temperature to the End of Exercise
The difference in core temperature from rest prior to exercise and at the end of exercise
Measured: Baseline (rest) prior to exercise and immediately after 20-minutes of exercise
Sweat Rate During Exercise
Amount of fluid loss through sweat over the course of exercise reported in milliliters per hour. This was calculated by taking difference of pre- and post-exercise body weight in kilograms while accounting for fluid intake and urine volume.
Measured: Change from Baseline (rest) prior to exercise and after 20-minutes of exercise
Dehydration After Exercise
Percentage of body weight fluid loss represented as a percentage of change from baseline and after 20 minutes of exercise
Measured: Change from baseline at rest and after 20-minutes of exercise
Lactate at 5-minutes Post Exercise
Blood lactate measured in millimoles per liter. This measurement was taken at the earlobe using a sterile lancet to obtain a drop of blood for analysis.
Measured: 5-minutes post exercise
Average Blood Oxygen Saturation Over the Course of High-intensity Interval Exercise
A pulse oximeter was placed on a finger and used to measure the percentage of oxygen saturated blood.
Measured: During a 20-minute high-intensity interval exercise session
Average Muscle Tissue Oxygenation During the High-intensity Portions of the Exercise Session
A near-infra red spectroscopy device was placed over the vastus lateralis of the dominant leg. This device measured the percentage of oxygenated muscle tissue.
Measured: During a 20-minute high-intensity interval exercise session
Average Muscle Tissue Oxygenation During the Active Rest Portions of the Exercise Session
A near-infra red spectroscopy device was placed over the vastus lateralis of the dominant leg. This device measured the percentage of oxygenated muscle tissue.
Measured: During a 20-minute high-intensity interval exercise session
Average Change in Muscle Tissue Oxygenation Between the Active Rest and High Intensity Portions Over the Course of High-intensity Interval Exercise.
This value was calculated by subtracting the average percentage of muscle tissue oxygenation during active rest portion of the exercise from the average percentage of muscle tissue oxygenation during the high-intensity portion of the exercise.
Measured: During a 20-minute high-intensity interval exercise session
Average Perceived Dyspnea Score Over the Course of High-intensity Interval Exercise
The participants were presented a vertical 200 millimeter long line with the top of the line labeled "No Difficulty" and the bottom of the line labeled "Most Difficult". The participants were then asked to indicated on this line how difficult it was to breath by pointing to a point along the line presented to them. Once the participant indicated along the line how difficult it was to breath the researcher then marked the spot on the line with a pen. To quantify the measurement, the distance, measured in millimeters, was taken from the "No Difficulty" end of the line (0 millimeters) to the indicated mark with the maximum difficulty recorded as 200 millimeters.
Measured: Measurements were taken prior to, 10 minutes into exercise, and immediately after exercise (at 20 minutes). These measurements were averaged to form a single value for the high-intensity interval exercise session.
Peak Thermal Sensation Over the Course of High-intensity Interval Exercise
Participants were asked to indicate on a visual scale from 0 (very cold) to 8 (very hot) their perceived thermal sensation. The highest recorded value was reported.
Measured: Baseline (rest) and every four minutes that was assessed up to 20 minutes into exercise. The highest value was recorded for each exercise session.
Average Thermal Sensation Over the Course of High-intensity Interval Exercise
Participants were asked to indicate on a visual scale from 0 (very cold) to 8 (very hot) their perceived thermal sensation.
Measured: Baseline (rest) and every four minutes that was assessed up to 20 minutes into exercise. These values were averaged into one value for each exercise session.
Peak Rating of Perceived Exertion Over the Course of High-intensity Interval Exercise
Participants were asked to indicate on a visual scale from 6 (no exertion) to 20 (maximal exertion) their perceived difficulty of exercise. The highest recorded value was reported.
Measured: Baseline (rest) and every four minutes that was assessed up to 20 minutes into exercise. The highest value was recorded for each exercise session.
Averaged Rating of Perceived Exertion Over the Course of High-intensity Interval Exercise
Participants were asked to indicate on a visual scale from 6 (no exertion) to 20 (maximal exertion) their perceived difficulty of exercise. The highest recorded value was reported.
Measured: Baseline (rest) and every four minutes that assessed up to 20 minutes into exercise. These values were averaged into one value for each exercise session.
Peak Heart Rate Over the Course of High-intensity Interval Exercise
Peak heart rate measured in beats per minute using a cardiograph impedance device (PhysioFlow)
Measured: During a 20-minute high-intensity interval exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start25 Nov 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- non-blinded randomized repeated measures crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Mermier PhD, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143801
- Sponsor's protocol ID
- 1680206
- Status last verified
- Mar 2022
- First submitted
- 24 Oct 2021
- Last updated
- 25 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Wells A, Fennel Z, Ducharme J, Masoud A, Houck J, Bellovary B, Deyhle M, Hsiao YY, Amorim F, Mermier C. Facemask Use During High Intensity Interval Exercise in Temperate and Hot Environments. J Occup Environ Med. 2022 May 1;64(5):421-428. doi: 10.1097/JOM.0000000000002461. Epub 2021 Dec 16.
PubMed 35608826
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Facemask Use During High-intensity Interval Exercise in Temperate and Hot Environments"
- ClinicalTrials.gov ID
- NCT05143801
- Acronym / sponsor ID
- 1680206
- Conditions
- Hypoxemia, Physiological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Posted 25 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate surgical mask use and high-intensity interval exercise across different environmental conditions.
Detailed description
Mask use in public settings is recommended to limit the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the disease known as COVID-19 and endorsed by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Wearing a mask during exercise may have implications for recreational exercisers and athletes that train and compete at a high exercise intensities as it has been shown to limit ventilation (VE) and increase end-tidal CO2 compared to a no-mask control. For example, N95 masks are designed to fit more tightly around the nose and mouth than other types of masks and have been shown to reduce markers of maximal exercise performance compared to a no-mask control for individuals performing an incremental ramp protocol on a cycle ergometer.
In contrast to N95 masks being reserved for health care workers, surgical masks certified by National Institute for Occupational Safety and Health are easily accessible to wear during exercise to reduce the risk of COVID-19 spread. Indeed, these masks fit more loosely than the N95, but did not reduce maximal power (Pmax), relative oxygen consumption (mL/kg/min), or test duration in two studies where participants performed a progressive maximal exercise test on a cycle ergometer. Further, surgical mask use during a progressive maximal cycling exercise protocol did not change cardiovascular, metabolic, and pulmonary measurements when compared to a no-mask condition in healthy individuals, with the exception of a decrease in maximal heart rate (HRmax). Another recent study using a progressive maximal cycling exercise protocol showed no change in (HRmax) using cycle ergometry when surgical mask use was compared to a no-mask condition. While this type of progressive maximal exercise test is frequently used for clinical and laboratory settings to assess cardiovascular, pulmonary, and metabolic markers, this type of exercise protocol is not often employed by athletes seeking to improve performance or recreational exercisers taking action to improve fitness. Because this exercise protocol is not used by athletes or recreational exercisers to train, it is difficult to translate the results of mask use during progressive maximal exercise tests to commonly practiced forms of exercise. In fact, a recent meta-analysis concludes that wearing a mask elicits a minimal impact on cardiovascular, respiratory, or metabolic variables across a wide array of exercise intensities and modalities, however, high intensity interval exercise (HIIE) was not included in this analysis, nor were hot environmental temperatures. Thus, the physiologic or metabolic responses while wearing a medical-grade surgical mask are not yet known with HIIE in both temperate and hot environments.
High intensity interval exercise is a popular time-efficient training method that involves short high intensity bouts followed by either active (low/moderate intensity exercise) or passive (no exercise) rest bouts. High intensity interval exercise has been shown to be a safe and effective way to increase physical fitness or performance in a diverse population that include exercisers in recreational, competitive, and clinical settings. Further, as HIIE can be performed in either an indoor or outdoor environment and using a mask may increase the physiological and perceptual strain of the exercise depending on the temperature and humidity. In a hot environment (40°C and 20% humidity), no difference was found in skin temperature under or outside a KN95 mask in healthy males that performed 45-minutes of moderate intensity physical activity that mimicked movements required in occupational settings. Also, no difference was found in whole body thermal discomfort, and an increase in perceived breathlessness by 36% was observed. In addition, surgical mask use during 30 minutes of mild uphill treadmill exercise did not increase risk of heat stroke in a hot and humid environment. To date, no research study has investigated the effects of surgical mask use during HIIE in different environmental conditions.
Therefore, the purpose of this study was to investigate the effects of surgical mask use during HIIE on cardiovascular, metabolic, thermoregulatory, and perceptual responses in temperate and hot environments.
Methodsː In a randomized fashion, ten healthy participants completed two HIIE sessions in a 36°C hot (HIIE-HOT) and two HIIE sessions in a 23°C temperate environment (HIIE-TEMP) while wearing (MASK) and not wearing a surgical mask (CON).
Procedures Anthropometrics and maximal Oxygen uptake measurements Before the experimental trials, participants visited the Exercise Physiology laboratories for anthropometrics and VO2max measurement. Body height was measured using a stadiometer (SECA, seca 216, Chino, CA, USA) and weight was measured using a digital scale (Cardinal DETECTO 758C, Webb City, MO). Then, participants completed a 5-minute warm-up at a self-selected exercise intensity prior to the VO2max test on an electrically braked cycle ergometer (Lode, Excalibur Sport, Groningen, The Netherlands). During the VO2max test, HR was measured using a Polar HR monitor (Polar, Polar H10, USA) with each test designed to last between 10 and 12 minutes. The starting resistance and the continuous increase in resistance (between 20-40 watts) throughout the test was based on the participants' self-reported fitness. Termination of the VO2max test occurred at volitional fatigue or when the participant could no longer maintain a cycling cadence of 60 revolutions per minute or higher. Gas-exchange was measured using a metabolic analyzer (Parvo Medics Inc, TrueOne 2400, Salt Lake City, UT) and data were analyzed using an 11-breath rolling average20. Primary criteria for a VO2max was categorized as an observed plateau that varied by less than 150 mlO2/min21. To determine a plateau using primary criteria, the mean of the absolute difference from each neighboring data point in the last 30 seconds of the 11-breath rolling average VO2 was compared against 150 mlO2/min21; if the average value was smaller, the test was categorized as a VO2max. In the absence of a plateau, a VO2max was confirmed if two of the three secondary criteria were met: 1) an RPE ≥17, 2) a respiratory exchange ratio (RER) of 1.1 or greater, and 3) a HR within 10 beats of estimated heart rate max using the Jones et al. equation (202 - 0.72 x age). The highest power output recorded from the VO2max test was used to calculate the high intensity and active recovery bouts for the HIIE sessions.
High Intensity Interval Exercise Trials Before all HIIE sessions participant's hydration status was assessed measuring urine specific gravity (USG) using a handheld refractometer (Cole-Parmer, RSA-BR90A, Vernon Hills, IL). A USG measurement lower than 1.020 g/cc allowed participants to proceed to the HIIE sessions. If USG was greater than 1.020 g/cc, then participants consumed 500 ml of water, and were reassessed after 30 minutes. This water provision was only repeated twice if USG remained above 1.020 g/cc.
A randomized cross over repeated measures design was used to compare cardiovascular, thermoregulatory, metabolic, and perceived responses before and during HIIE across four experimental trials performed during two visits. For each visit, which was separated by a minimum of 72 hours, the participants completed two HIIE sessions separated by 3 hours of rest. Each HIIE bout consisted of 10 bouts lasting 30 seconds performed at 85% Pmax followed by 90 seconds of active recovery at 30% Pmax. The HIIE sessions were performed in a temperate environment (23°C, 25% relative humidity) with (TEMP/MASK) and without a surgical mask (TEMP/CON), and in a hot environment (36°C, 14% relative humidity) with (HOT/MASK) and without a surgical mask (HOT/CON). During the exercise protocol participants were allowed to drink water.
During HIIE sessions with a mask, all participants were instructed to wear the surgical mask snugly over their nose and mouth. The participants fitted the flexible metal plate within the surgical mask over the bridge of the nose and had the bottom of the mask cover underneath the chin. During the 3-hour rest period participants were provided a 350-calorie meal (7g of Fat; 64g Carbohydrate; 9g Protein) and water ad libitum.
Cardiovascular Measurements Before every HIIE trial and after 5-minutes of seated rest, resting blood pressure was measured using a sphygmomanometer, and stethoscope. A cardiac impedance device (PhysioFlow®, NeuMeDex, Bristol, PA) calibrated per manufacturer guidelines was used to indirectly measure cardiac output (CO), stroke volume (SV), and HR. These measurements were taken continuously using 10-second averaging provided by the PhysioFlow® software during each HIIE session.
Metabolic Measurements A near infra-red spectroscopy (NIRS) device (Moxy, Moxy Monitor System, MN, USA) was used to measure muscle tissue oxygenation every second during each HIIE session. The highest muscle tissue oxygenation value from each active rest period (MTO active rest %) was averaged for each HIIE session. Additionally, the lowest muscle tissue oxygenation (MTO during HIIE %) value per high intensity bout was recorded and averaged from each HIIE session. The difference of the average MTO active rest % and MTO during HIIE % was used to calculate the muscle tissue oxygenation difference (MTO difference %). All MTO measurements were taken on the dominant leg at a marked location on the vastus lateralis that would allow movement without interference from the NIRS device. A pulse oximeter (Caretaker, Caretaker Medical, USA) was used to measure SpO2 during HIIE. Blood lactate measurements (Lactate Plus, NOVA Biomedical, MA) were taken in duplicate at the ear lobe immediately before, and 5-minutes post HIIE.
Perceptual Measurement before and during HIIE Borg's rating of perceived exertion (6 rest to 20 maximal effort) scale (RPE) and thermal sensation (0 very cold to 8 very hot) was measured immediately before and every four minutes into HIIE. A breathlessness scale (0 mm no breathlessness to 200 mm maximal breathlessness)was used immediately before, at 10-minutes, and immediately after exercise to record subjective change in difficulty breathing. The highest measurements for both RPE (peak RPE) and thermal sensation (peak thermal sensation) were recorded per HIIE session performed. Additionally, RPE (RPE avg) and dyspnea scores were averaged over time for every HIIE session.
Thermal strain and hydration measurements During each HIIE exercise session continuous core temperature measurements were taken using rectal thermistors (Level 1 esophageal/rectal temperature probe, Smiths Medical, Minneapolis, MN, USA) connected to a thermometer (Precision 4000, YSI Incorporated, Yellow Springs, OH, USA) and monitored to ensure participant safety. Additionally, ∆ core temperature (i.e., the difference between peak core temperature and core temperature prior to starting exercise) and peak core temperature were recorded for each HIIE session. Sweat rate and dehydration were calculated from pre-exercise nude weight, post-exercise nude weight, water ingestion, and post-exercise urine output measurements27. Participants were asked to measure and report their pre-exercise and post-exercise nude weight using a digital scale (Cardinal DETECTO 758C, Webb City, MO) in a private room.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- non-blinded randomized repeated measures crossover
| Arm | Type | Receives |
|---|---|---|
| No mask temperate | Active comparator | Other: High-intensity interval exercise without using a surgical face mask in a temperate environmentParticipant exercised in room temperature environment not wearing a surgical face mask |
| Mask temperate | Experimental | Device: High-intensity interval exercise with surgical face mask in a temperate environmentParticipant exercised in room temperature environment while wearing a surgical face mask |
| No mask hot | Active comparator | Other: High-intensity interval exercise without using a surgical face mask in a hot environmentParticipant exercised in a hot environmental temperature not wearing a surgical face mask |
| Mask hot | Experimental | Device: High-intensity interval exercise with surgical face mask in a hot environmentParticipant exercised in a hot environmental temperature while wearing a surgical face mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older and, are able to both speak and read in English.
- Physically active and used to high-intensity exercise.
- No known serious medical conditions.
Key exclusion criteria (3 listed)
- Vulnerable populations such as children, minors, pregnant women, and intellectually challenged individuals.
- Those with cardiovascular, renal, metabolic, or chronic respiratory disease, smokers or those who have quit smoking less than 6 months ago, and those who use an inhaler to control for exercise-induced asthma.
- In addition, exclusion criteria include participants who show any signs or symptoms of COVID-19 and have had exposure to anyone with COVID-19 symptoms or any person that has tested positive for COVID-19.
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 |
|---|---|---|
| High-intensity interval exercise with surgical face mask in a temperate environmentParticipants performed high-intensity interval exercise in a temperate environmental condition while wearing surgical face mask | Device | Mask temperate |
| High-intensity interval exercise with surgical face mask in a hot environmentParticipants performed high-intensity interval exercise in a hot environmental condition while wearing surgical face mask | Device | Mask hot |
| High-intensity interval exercise without using a surgical face mask in a hot environmentParticipants performed high-intensity interval exercise in a hot environmental condition without wearing a surgical face mask | Other | No mask hot |
| High-intensity interval exercise without using a surgical face mask in a temperate environmentParticipants performed high-intensity interval exercise in a temperate environmental condition without wearing a surgical face mask | Other | No mask temperate |
Primary outcome
Average Heart Rate Over the Course of High-intensity Interval Exercise
Time frame: During a 20-minute high-intensity interval exercise session
Heart rate measured in beats per minute using a cardiograph impedance device (PhysioFlow)
Average Stroke Volume Over the Course of High-intensity Interval Exercise
Time frame: During a 20-minute high-intensity interval exercise session
Stroke volume measured in milliliters using a cardiograph impedance device (PhysioFlow)
Average Cardiac Output Over the Course of High-intensity Interval Exercise
Time frame: During a 20-minute high-intensity interval exercise session
Cardiac output measured in liters per minute using a cardiograph impedance device (PhysioFlow)
Peak Core Temperature
Time frame: The highest value recorded during a 20-minute high-intensity interval exercise session
The highest core body temperature measured in degrees Celsius during high-intensity interval exercise
Change From Baseline (Rest) in Core Temperature to the End of Exercise
Time frame: Baseline (rest) prior to exercise and immediately after 20-minutes of exercise
The difference in core temperature from rest prior to exercise and at the end of exercise
Sweat Rate During Exercise
Time frame: Change from Baseline (rest) prior to exercise and after 20-minutes of exercise
Amount of fluid loss through sweat over the course of exercise reported in milliliters per hour. This was calculated by taking difference of pre- and post-exercise body weight in kilograms while accounting for fluid intake and urine volume.
Dehydration After Exercise
Time frame: Change from baseline at rest and after 20-minutes of exercise
Percentage of body weight fluid loss represented as a percentage of change from baseline and after 20 minutes of exercise
Lactate at 5-minutes Post Exercise
Time frame: 5-minutes post exercise
Blood lactate measured in millimoles per liter. This measurement was taken at the earlobe using a sterile lancet to obtain a drop of blood for analysis.
Average Blood Oxygen Saturation Over the Course of High-intensity Interval Exercise
Time frame: During a 20-minute high-intensity interval exercise session
A pulse oximeter was placed on a finger and used to measure the percentage of oxygen saturated blood.
Average Muscle Tissue Oxygenation During the High-intensity Portions of the Exercise Session
Time frame: During a 20-minute high-intensity interval exercise session
A near-infra red spectroscopy device was placed over the vastus lateralis of the dominant leg. This device measured the percentage of oxygenated muscle tissue.
Average Muscle Tissue Oxygenation During the Active Rest Portions of the Exercise Session
Time frame: During a 20-minute high-intensity interval exercise session
A near-infra red spectroscopy device was placed over the vastus lateralis of the dominant leg. This device measured the percentage of oxygenated muscle tissue.
Average Change in Muscle Tissue Oxygenation Between the Active Rest and High Intensity Portions Over the Course of High-intensity Interval Exercise.
Time frame: During a 20-minute high-intensity interval exercise session
This value was calculated by subtracting the average percentage of muscle tissue oxygenation during active rest portion of the exercise from the average percentage of muscle tissue oxygenation during the high-intensity portion of the exercise.
Average Perceived Dyspnea Score Over the Course of High-intensity Interval Exercise
Time frame: Measurements were taken prior to, 10 minutes into exercise, and immediately after exercise (at 20 minutes). These measurements were averaged to form a single value for the high-intensity interval exercise session.
The participants were presented a vertical 200 millimeter long line with the top of the line labeled "No Difficulty" and the bottom of the line labeled "Most Difficult". The participants were then asked to indicated on this line how difficult it was to breath by pointing to a point along the line presented to them. Once the participant indicated along the line how difficult it was to breath the researcher then marked the spot on the line with a pen. To quantify the measurement, the distance, measured in millimeters, was taken from the "No Difficulty" end of the line (0 millimeters) to the indicated mark with the maximum difficulty recorded as 200 millimeters.
Peak Thermal Sensation Over the Course of High-intensity Interval Exercise
Time frame: Baseline (rest) and every four minutes that was assessed up to 20 minutes into exercise. The highest value was recorded for each exercise session.
Participants were asked to indicate on a visual scale from 0 (very cold) to 8 (very hot) their perceived thermal sensation. The highest recorded value was reported.
Average Thermal Sensation Over the Course of High-intensity Interval Exercise
Time frame: Baseline (rest) and every four minutes that was assessed up to 20 minutes into exercise. These values were averaged into one value for each exercise session.
Participants were asked to indicate on a visual scale from 0 (very cold) to 8 (very hot) their perceived thermal sensation.
Peak Rating of Perceived Exertion Over the Course of High-intensity Interval Exercise
Time frame: Baseline (rest) and every four minutes that was assessed up to 20 minutes into exercise. The highest value was recorded for each exercise session.
Participants were asked to indicate on a visual scale from 6 (no exertion) to 20 (maximal exertion) their perceived difficulty of exercise. The highest recorded value was reported.
Averaged Rating of Perceived Exertion Over the Course of High-intensity Interval Exercise
Time frame: Baseline (rest) and every four minutes that assessed up to 20 minutes into exercise. These values were averaged into one value for each exercise session.
Participants were asked to indicate on a visual scale from 6 (no exertion) to 20 (maximal exertion) their perceived difficulty of exercise. The highest recorded value was reported.
Peak Heart Rate Over the Course of High-intensity Interval Exercise
Time frame: During a 20-minute high-intensity interval exercise session
Peak heart rate measured in beats per minute using a cardiograph impedance device (PhysioFlow)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35608826Wells A, Fennel Z, Ducharme J, Masoud A, Houck J, Bellovary B, Deyhle M, Hsiao YY, Amorim F, Mermier C. Facemask Use During High Intensity Interval Exercise in Temperate and Hot Environments. J Occup Environ Med. 2022 May 1;64(5):421-428. doi: 10.1097/JOM.0000000000002461. Epub 2021 Dec 16.
- Individual participant dataSharing planned: Undecided
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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 High-intensity interval exercise with surgical face mask in a temperate environment, High-intensity interval exercise with surgical face mask in a hot environment and High-intensity interval exercise without using a surgical face mask in a hot environment in people with Hypoxemia and Physiological Stress, run by University of New Mexico 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 3 inclusion and 3 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 25 Apr 2022. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Heart Rate Over the Course of High-intensity Interval Exercise (time frame: During a 20-minute high-intensity interval exercise session). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05143801, which also lists 1 linked publication.
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 25 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.