key: cord-0979526-k2uhmxi2
authors: Kampert, Matthew; Singh, Tamanna; Sahoo, Debasis; Han, Xiaozhen; Van Iterson, Erik H.
title: Effects of Wearing an N95 Respirator or Cloth Mask Among Adults at Peak Exercise: A Randomized Crossover Trial
date: 2021-06-30
journal: JAMA Netw Open
DOI: 10.1001/jamanetworkopen.2021.15219
sha: 61beb0fbaacc75aef3f7520235b0c1ab830bcee7
doc_id: 979526
cord_uid: k2uhmxi2

This randomized crossover trial examines the effects of wearing a cloth mask or N95 respirator vs no mask at peak exercise among healthy, active adults.

The Centers for Disease Control and Prevention (CDC) state that the coronavirus disease 2019 (COVID-50 19) caused by SARS-CoV-2, is thought to spread mainly between people who are in close contact with one 51 another within about 6 feet (1.8 m) when an infected person coughs, sneezes or talks. 1 Aerosol droplets 52 containing the SARS-CoV-2 virus have been shown to remain suspended in air for ∼3h. 2 These droplets can 53 land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. It is important to 54 discuss minimal infectious dose and viral load exposure. The minimal infective dose is defined as the lowest 55 number of viral particles that cause an infection in 50% of individuals, The human infectious dose of SARS-56

CoV-2 remains unknown, but animal studies are a plausible surrogate. 3 as an effective way to treat obesity, diabetes, or heart and lung disease that are considered to place a patient at 66 high risk, but also utilizing exercise to precondition individuals prior to developing COVID-19. It is important 67 to consider the significant decrease in cardiorespiratory fitness (CRF) and profound loss of muscle mass when 68 patients are hospitalized for weeks at a time, especially if mechanical ventilation is required. After fighting for 69 their life against COVID-19, at the time of discharge patients will have an ongoing battle to regain the CRF and 70 strength that they lost during the illness. Hence, it is now even more important than ever to prophylactically 71 increase CRF, muscular strength, and optimize body composition through exercise preconditioning. 72

The use of face masks have also been shown to be effective in decreasing transmission. A 73 randomized controlled trial of 446 nurses comparing the use of surgical masks with the N95 respirator in 74 Version #1 Submitted 5/14/2020 4 | P a g e protecting health care workers against influenza found that use of a surgical mask compared with an N95 75 respirator resulted in noninferior rates of laboratory confirmed influenza. 5 In an observational study, researchers 76 assessing the effect of community-wide mask usage to control COVID-19 observed 11 COVID-19 clusters in 77 recreational "mask-off" settings compared to only 3 in workplace "mask-on" settings. Concluding that mask 78 wearing may contribute to the control of COVID-19 by reducing the amount of emission of infected saliva and 79 respiratory droplets from individuals with subclinical or mild COVID-19. 6 80

The presence of gaps between the mask and the facial contours will result in air leakage around the mask 81 (face seal leakage) reducing the effectiveness of the mask. .Researchers assessing the efficiencies of protection 82 offered to by N95 respirator and surgical masks in 25 subjects to evaluate the 2 pathways of aersol particle 83 penetration (filter vs fasce seal) into respiratory protection devices (RPDs). They concluded health care 84 environments should be increasingly focused on the peripheral design rather than on the further improvement of 85 the filter media. The faces eal leakage was found to represent the main pathway for the submicrometer particles 86 penetrating into the mask. Thus, concluding that the priority in product development should be given to 87 establishing a better fit that would minimize the faces eal leakage to increase protection for the individual 88 wearing the mask. 7 In addition to being effective at decreasing the spread of the virus, a mask must be 89 comfortable enough to be tolerated by the wearer to maximize compliance. 90

Konda et.al tested the performance of over 15 natural and synthetic fabrics to determine the best 91 materials to use when making a cloth mask. They found that cotton sheets with high thread counts provide the 92 best mechanical protection. However, other materials such as natural silk, chiffon weave or flannel can likely 93 provide good electrostatic filtering of particles. Combining layers to form hybrid masks, leveraging mechanical 94 and electrostatic filtering may be an effective approach. This could include high thread count cotton combined 95 with two layers of natural silk or chiffon, for instance. A quilt consisting of two layers of cotton sandwiching a 96 cotton−polyester batting also worked well. In all of these cases, the filtration efficiency was >80% for <300 nm 97 and >90% for >300 nm sized particles. More importantly they also found that face seal leakage around the mask 98 area can degrade efficiencies > 60%. 8 99 Version #1 Submitted 5/14/2020 5 | P a g e Following the severe acute respiratory syndrome (SARS) outbreak that occured in March 2003, a study 100 by Li et.al. was conducted to investigate the effects of wearing N95 and surgical facemasks by assessing the 101 subjective perception of discomfort and heart rate response to each mask following a walking protocol. Subject 102 completed 3 walking intervals as follows: 20 min at 2.0 mph (3.2 km/h), 10 min at 3.0 mph (4.8 km/h),10 min 103 at 4.0 mph (6.4 km/h) and resting 10 min between each interval. Subjects rated ten sensations of discomfort: 104 humidity, heat, breathing resistance, itchiness, tightness, saltiness, feeling unfit, odor, fatigue, and overall 105 discomfort, and asked to reply to the question ''How do you like the facemask?'' by rating on a scale ranging 106 from 0 to 10, with 0 representing ''not at all'', 5 representing ''acceptable'' and 10 representing ''very fond 107 of''. In general, the ratings for humidity, heat, breath resistance and overall discomfort increased gradually with 108 time and increase of workload. Surgical facemasks had significantly lower ratings than the N95 facemask, 109

which suggested that when wearing either of the surgical facemasks the subject felt drier, cooler, more able to 110 breathe easily and less uncomfortable than when wearing either of the N95 facemasks. The pattern of changes 111 in mean heart rate amongst these facemasks is similar, reaching peaks at the end of the third exercise session. 112

The subjects had lower mean heart rates when wearing surgical masks than when wearing N95 facemasks. High 113

breathing resistance made it difficult for the subject to breathe and take in sufficient oxygen. 9 114 Significance

The CDC currently recommends that everyone wear a cloth face covering (not surgical masks or N-95 116 respirators) in public, especially in places where maintaining social distancing is difficult to maintain (e.g., 117

grocery stores and pharmacies). 10 These recommendations become increasing important as the country 118 gradually begins to lift restrictions by opening more businesses including gyms and fitness centers. Johns 119

Hopkins released a report, "Public Health Principles for Phased Reopening During COVID-19: Guidance for 120

Governors" outlining how to re-open certain categories of activities including gyms and fitness centers while 121 reducing COVID-19 risk. The report states that regardless of business specific considerations, there are 122 measures that can be taken to mitigate the risk of infection to protect individuals. COVID-19 mitigation 123 measures included the use of nonmedical cloth masks, incorporating engineering controls such as physical 124 barriers where possible, and reconfiguring space to enable people to be located at least 6 feet apart. 11 The report 125 Version #1 Submitted 5/14/2020 6 | P a g e also ranks certain activities by their contact intensity, number of contacts, and the potential to modify them to 126 reduce risk. Identifying gyms and fitness studios as "nonessential" businesses, rating contact intensity, number 127 of contacts, and modification potential all as medium. 11 The purpose of a cloth mask is not to protect the 128 individual wearing the mask, as much as it is to protect other people surrounding them by reducing the viral 129 load shedding into the environment. If individuals are able to exercise at home or outside while practicing 130 appropriate social distancing, then it is reasonable to not wear a mask. However, the COVID-19 pandemic can 131 make it challenging to maintain a physically active lifestyle, and has created concern about exercising as gyms 132

begin to open back up for business. Wearing a mask during exercise is going to impede the ease of breathing. 133

Although decreased faceseal leakage results in improved protection, it increases airflow resistance and impede 134 the ease of breathing, which becomes increasing important during exercise. This highlights the importance of 135 assessing the risk vs benefits of the mask and finding the best mask for that specific exerciser. For high risk 136

individuals it might be more beneficial to protect their self by wearing mask with minimal faceseal leakage. 137

However, a mask with slightly more faceseal leakage might be more appropriate for individuals that are 138 asymptomatic and exercising at a higher intensity. The CDC recommendation to wear a cloth face covering is 139

to protect people around the individual wearing mask more than individual, which highlights the importance of 140 everyone wearing a mask to protect the community. 12 Especially during times of increased viral shedding 141 including talking, coughing, sneezing, or increased ventilation during physical activity. 142

This study intends to find out how a cloth mask may impact exercise capacity, to provide guidance for 143 exercisers to adjust their expectations and training accordingly. We plan to asses exercise capacity through 144 estimated peak oxygen consumption (eVO 2 peak), oxygen saturation and level of perceived exertion during 145 treadmill based exercise while wearing a cloth mask compared to exercising without a cloth mask. The potential 146 significance of this study is to determine if subjects can exercise safely and if their exercise training needs to be 147 adjusted while following the current recommendations of wearing a cloth mask in public. The degree of airflow 148 limitation experienced will depend on the type and fit of the mask being worn, and inadequate airflow could 149 possibly result in CO2 re-breathing if all air was not fully discharged from the mask with each breath. This re-150 breathing of CO2 could potentially limit the workload leading to a detriment in performance, and increase in 151 exercising without a facemask, limiting peak exercise when non-inferiority margin is 1 estimated metabolic 163 equivalent ( eMET 3.5 mlO 2 *kg -1 *min -1 ). 164

Our alternative hypothesis H 1 states that exercising with a mask will not be inferior to the current standard of 165 exercising without a facemask, limiting peak exercise when non-inferiority margin is 1 eMET. 166

Specific Aims 167 1) To gain further understanding on effects exercising with a cloth mask has on exercise capacity.

Our working hypothesis is that wearing a face mask will limit exercise capacity by a minimal clinically 169 important difference (MCID) of 1 estimate metabolic equivalent (eMET we will expand our enrollment to include non Cleveland Clinic employees. Employees will not be solicited by 178 Version #1 Submitted 5/14/2020 8 | P a g e direct initiation. Recruitment will involve only posted notice or general advertising that does not pressure 179 employees into participating for fear of job loss, delayed promotion, or other influences from their superior. 180

Study Design: The study design is a prospective crossover non-inferiority trial where subjects will complete 3 181 separate graded exercise treadmill tests each time wearing either No Mask, N-95 Mask (3M), or Cloth Mask 182 (Boco). The order of the mask worn will be randomly assign to minimize familiarization or training effect. All 183 testing will be performed in a Cleveland Clinic facility following standardized COVID-19 screening 184

precautions. We will compare the data collected from each test to asses for differences between subject comfort, 185 peak exercise capacity (eMET), heart rate response during exercise and recovery. 186

Testing: After completing the informed consent and being medically cleared 13 , subjects will then perform a 187 symptom limited graded exercise treadmill test using a modified Balke protocol. The modified Balke, which is 188 a well-accepted treadmill protocol that keeps the speed constant and increases workload by grade. Subjects will 189 rest for 3 minutes and resting heart rate, blood pressure, subjective perceptions of the face mask will be 190 measured. Subjects then will walk at 0% grade at 3 miles per hour for 2 minutes. Elevation will be increased 191 by 2% after the initial 2 minutes and by 1% each minute thereafter until the test is terminated. Heart rate will be 192 monitor by Polar H10 heart rate monitor and oxygen saturation will be measured with a pulse oximeter. 14 We 193 will continue to monitor heart rate during recovery at 1, 3 and 5 minutes post exercise. We will monitor each 194 stage for perceived exertion, feelings of light headedness, anxiety, and discomfort. The test will also be 195 terminated at the request of the subject or if any chest pain develops. Total sample size n= 20 NoMask = (1 + 1/k) * 2 * ((Z1 -+ Z1 -)/ ( + ))2 Mask = * NoMask where 2 is 239 the variance, and = Mask -NoMask is known as the allowable difference, which is the true mean 240 difference between the new treatment (Mask) and the control (NoMask). 1) = 3.5mlO 2 *kg -1 *min -1 (1 241 eMET=3.5 mlO 2 *kg -1 *min -1 ): a (clinically meaningful) minimal detectable difference 2) k=1 : the ratio of the 242 sample size of treatment(mask) group to the sample size of control(NoMask) group 3) 2= 3.5: population 243 eMET change variance 4) power: 0.9 5) 5% expected rate of drop-outs 6) d=0: Descriptive statistics will be 244 used to characterize the patient cohort. Demographic variables will be described using mean with standard 245 deviations for continuous variables and counts with percentages for categorical variables. The Wilcoxon signed-246 rank signed test or paired-sample t-test will be used to compare continuous variables between the Mask and 247

NoMask exercise. McNemar's test will be applied to compare categorical variables. Mixed-effected linear 248 regression models will be applied for the repeated measures data. Pearson correlation coefficient will be 249 calculated whenever it is appropriate. Analyses will be two-tailed and performed at significance level of 0.05 250 with SAS 9.3 software (SAS Institute, Cary, NC). 251

Project Timeline

All testing expected to be completed within 2 weeks, followed by data and statistically analysis. We 253

intend to have this study written up and published prior to the opening of public gyms in Ohio. 254 Budget 255 256 Funding by Joseph Parambil and Pulmonary Institute

Debasis Sahoo MD will serve as an investigator assisting with the study design 261 and analysis of data

Matthew Kampert MS, DO will serve as an investigator and Exercise Physiologist 263 conducting exercise testing for this study. He will coordinate the overall scope of the project

Tamanna Singh, MD 266 Co-Investigator (CCF)

Han Xiaozhen and Xiaofeng Wang assist with statistical design and analysis of data

Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-272

Question List for COVID-19 | Homeland Security

People Who Are at Higher Risk for Severe Illness | CDC

Surgical Mask vs N95 Respirator Among Health Care Workers

The role of community-wide wearing of face mask for control of coronavirus 280 disease 2019 (COVID-19) epidemic due to SARS-CoV-2

Performance of an N95 filtering facepiece particulate respirator and a surgical 283 mask during human breathing: Two pathways for particle penetration

Fabrics Used in Respiratory Cloth 286 Masks

Effects of wearing N95 and surgical facemasks on heart rate, thermal stress and subjective 288 sensations

Recommendation Regarding the Use of Cloth Face Coverings | CDC

Public Health Principles for a Phased Reopening During COVID-19: Guidance for 292 Governors 2 AUTHORS

Cloth Face Coverings: Questions and Answers | CDC

Updating ACSM's recommendations for exercise preparticipation health screening

Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise