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"Facemask Use During High-intensity Interval Exercise in Temperate and Hot Environments"

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ClinicalTrials.gov Identifier: NCT05143801
Recruitment Status : Completed
First Posted : December 3, 2021
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Christine Mermier PhD, University of New Mexico

Brief Summary:
To investigate surgical mask use and high-intensity interval exercise across different environmental conditions.

Condition or disease Intervention/treatment Phase
Hypoxemia Physiological Stress Device: High-intensity interval exercise with surgical face mask in a temperate environment Device: High-intensity interval exercise with surgical face mask in a hot environment Other: High-intensity interval exercise without using a surgical face mask in a hot environment Other: High-intensity interval exercise without using a surgical face mask in a temperate environment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: non-blinded randomized repeated measures crossover
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: "Facemask Use During High-intensity Interval Exercise in Temperate and Hot Environments"
Actual Study Start Date : November 25, 2020
Actual Primary Completion Date : June 11, 2021
Actual Study Completion Date : June 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No mask temperate
Participant exercised in room temperature environment not wearing a surgical face mask
Other: High-intensity interval exercise without using a surgical face mask in a temperate environment
Participants performed high-intensity interval exercise in a temperate environmental condition without wearing a surgical face mask

Experimental: Mask temperate
Participant exercised in room temperature environment while wearing a surgical face mask
Device: High-intensity interval exercise with surgical face mask in a temperate environment
Participants performed high-intensity interval exercise in a temperate environmental condition while wearing surgical face mask

Active Comparator: No mask hot
Participant exercised in a hot environmental temperature not wearing a surgical face mask
Other: High-intensity interval exercise without using a surgical face mask in a hot environment
Participants performed high-intensity interval exercise in a hot environmental condition without wearing a surgical face mask

Experimental: Mask hot
Participant exercised in a hot environmental temperature while wearing a surgical face mask
Device: High-intensity interval exercise with surgical face mask in a hot environment
Participants performed high-intensity interval exercise in a hot environmental condition while wearing surgical face mask




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. Sweat rate during exercise [ Time Frame: 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.

  7. Dehydration after exercise [ Time Frame: After 20-minutes of exercise ]
    Proportion of body weight fluid loss represented as a percentage after exercise

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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. These measurements were averaged to form a single value for the high-intensity interval exercise session. ]
    The participants asked to indicate on visual analog scale with a 200 millimeter long line with one end labeled "No Difficulty" and the other end labeled "Most Difficult". The distance to the indicated mark was then measured in millimeters from the "No Difficulty" side.

  14. 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.

  15. 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.

  16. 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.

  17. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05143801


Locations
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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
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Responsible Party: Christine Mermier PhD, Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT05143801    
Other Study ID Numbers: 1680206
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory