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.