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

NCT05143801 | Completed Results FDA Device

• 1 other identifier: 1680206
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxemia; Physiological Stress

Outcome Measures

Primary Outcomes (18)

• Average Heart Rate Over the Course of High-intensity Interval Exercise

  Heart rate measured in beats per minute using a cardiograph impedance device (PhysioFlow)

  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)

  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)

  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

  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

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  During a 20-minute high-intensity interval exercise session

Study Arms (4)

No mask temperate

ACTIVE COMPARATOR

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

Mask temperate

EXPERIMENTAL

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

No mask hot

ACTIVE COMPARATOR

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

Mask hot

EXPERIMENTAL

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

Interventions

High-intensity interval exercise with surgical face mask in a temperate environment DEVICE

Participants performed high-intensity interval exercise in a temperate environmental condition while wearing surgical face mask

Mask temperate

High-intensity interval exercise with surgical face mask in a hot environment DEVICE

Participants performed high-intensity interval exercise in a hot environmental condition while wearing surgical face mask

Mask hot

High-intensity interval exercise without using a surgical face mask in a hot environment OTHER

Participants performed high-intensity interval exercise in a hot environmental condition without wearing a surgical face mask

No mask hot

High-intensity interval exercise without using a surgical face mask in a temperate environment OTHER

Participants performed high-intensity interval exercise in a temperate environmental condition without wearing a surgical face mask

No mask temperate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• 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.

  PMID: 35608826 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The current study design employed a three-hour rest between same day trials. Thus, the fatigue from the first trial may have carried over to the second trial. However, this limitation was thought to be minimized as the trial order was randomized, the participants were aerobically fit individuals, and only a total of 5 minutes was spent exercising at 85% of their maximum power output per trial.

Results Point of Contact

• Title: Dr. Christine Mermier
• Organization: University of New Mexico

cmermier@unm.edu

5052772664

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: non-blinded randomized repeated measures crossover

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: December 3, 2021
• Study Start: November 25, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: April 25, 2022
• Results First Posted: April 25, 2022

Record last verified: 2022-03

Locations

US (1)