Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.

If healthcare providers are going to recommend that individuals exercise with cloth masks, it
is imperative that future research is conducted to evaluate the degree to which airflow can
be limited during exercise by wearing a cloth mask. At the completion of the study, the
investigators will have further understanding of the effects of face masks during treadmill
based running. To the investigators knowledge this is the first study to assess the effects
of wearing protective cloth mask on exercise capacity.

Hypothesis The null hypothesis HO states that exercising with a cloth mask will be inferior
to the current standard of exercising without a facemask, limiting peak exercise when
non-inferiority margin is 1 estimated metabolic equivalent ( eMET 3.5 mlO2*kg-1*min-1).

The alternative hypothesis H1 states that exercising with a mask will not be inferior to the
current standard of exercising without a facemask, limiting peak exercise when
non-inferiority margin is 1 eMET.

EXPERIMENTAL DESIGN & METHODS Subject Recruitment: The investigators will recruit 20 subjects
though the Cleveland Clinic. Inclusion Criteria: Healthy subjects age > 18, Exclusion
Criteria: Any long-term disease that would interfere with their ability to exercise safely,
fever >100.4 F, or pregnancy. Informed consent will be obtained by the CoPI, and need for
medical clearance determined based on ACSM's 2015 preparticipation guidelines. To remain
compliant with enterprise guidelines we will not be recruiting healthy subjects outside of
the Cleveland Clinic staff at this time to avoid increase COVID-19 exposure risk. However, if
the enterprise changes the guidelines we will expand our enrollment to include non Cleveland
Clinic employees. Employees will not be solicited by direct initiation. Recruitment will
involve only posted notice or general advertising that does not pressure employees into
participating for fear of job loss, delayed promotion, or other influences from their
superior.

Study Design: The study design is a prospective crossover non-inferiority trial where
subjects will complete 3 separate graded exercise treadmill tests each time wearing either No
Mask, N-95 Mask (3M), or Cloth Mask (Boco). The order of the mask worn will be randomly
assign to minimize familiarization or training effect. All testing will be performed in a
Cleveland Clinic facility following standardized COVID-19 screening precautions. The
investigators will compare the data collected from each test to asses for differences between
subject comfort, peak exercise capacity (eMET), heart rate response during exercise and
recovery.

Testing: After completing the informed consent and being medically cleared, subjects will
then perform a symptom limited graded exercise treadmill test using a modified Balke protocol
with continuous 12-lead EKG monitoring. Exercise tests will be stopped if any significant
cardiac arrhythmias occur or significant ST segment depressions develops. The test will be
terminated if ST elevation (> 1.0 mm), marked ST displacement (horizontal or downsloping of >
2mm, measured 60 to 80 ms after the J point), moderate to severe angina, Signs of poor
perfusion (cyanosis or pallor), Sustained ventricular tachycardia or other arrhythmia,
including second or third decree AV block, that interferes with normal maintenance of cardiac
output during exercise, or development of bunle-branch block that cnannot be distinguished
from bentricular tachycardia. The modified Balke, which is a well-accepted treadmill protocol
that keeps the speed constant and increases workload by grade. Subjects will rest for 3
minutes and resting heart rate, blood pressure, subjective perceptions of the face mask will
be measured. Subjects then will walk at 0% grade at 3 miles per hour for 2 minutes. Elevation
will be increased by 2% after the initial 2 minutes and by 1% each minute thereafter until
the test is terminated. Heart rate, RPEand oxygen saturation will be measured with a pulse
oximeter at baseline, last 5-10 seconds of each stage and the investigators will continue to
monitor heart rate during recovery at 1, 3 and 5 minutes post exercise. The investigators
will monitor each stage for perceived exertion, feelings of light headedness, anxiety, and
discomfort. The test will also be terminated at the request of the subject or if any chest
pain develops. The scale of measuring subjective perceptions instrument will be adminstereted
after collecting 5 minutes of resting, end of the exercise test, and at 5 minutes post
recovery. The graded exercise test will be performed once with No Mask, once with a 3M 8200
N-95 Respirator, and once with a Cloth Mask (Boco). Subjects will be randomized by a random
number generater (1= No Mask, 2= N-95, 3= Cloth Mask) to determine the order the perform each
exercise test No Mask, N-95 or Cloth Mask and will complete the other tests 2 atleast 1 day
apart. Subjects will be instructed to abstain from exercise for 2 days before the test.

Mask:

3M 8200 N-95 Respirator obtain from a third party provider. N-95 Respirators have been
purchased outside the Cleveland Clinic supply chain. Cloth Face Mask manufactured by Boco is
a custom designed two-layer face masks are built with a tightly woven polyester outer shell
fabric and a soft, breathable performance knit mesh inner linig. Includes a slit pocket where
a filter can be added.