Clinical trial NCT04706299: Effects of Surgical Mask Use on Peak Torque, Total Work and Interset Fatigability During Isokinetic Strength Testing
Official title: Effects of Surgical Mask Use on Peak Torque, Total Work and Interset Fatigability During Isokinetic Strength Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of COVID-19
Keywords: Exercise
Face Mask
COVID-19
Resistance Training
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a prospective study conducted using a randomized-control crossover design where participants will complete resistance exercise (RE) protocol utilizing a Biodex System 4 and Advantage V5 software with a standard leg attachment, on 2 separate days with at least 48 hours and no greater than seven days between tests.
Primary purpose: PREVENTION

Brief summary: The coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is highly transmittable person-to-person when an infected individual coughs, sneezes or talks while within at least 6 feet (1.8 m) of a neighboring individual. Guidelines set forth by the Centers for Disease Control and Prevention (CDC) state that nose and mouth facial coverings are recommended at all levels for source control as a simple barrier to help prevent respiratory droplet transmission. It is important to remember that increased viral shedding occurs during elevated ventilatory rates that are observed during exercise within a shared space, such as gyms or fitness studios increase the rate of transmission. However, there is limited research studying the effects of mask use during exercise, and no research evaluating these effects specifically during resistance-based exercise. Therefore, the purpose of this investigation is to examine the effects of wearing a surgical face mask while performing resistance exercise on average peak force, total work, heart rate (HR), oxygen saturation (SpO2) and breathing discomfort.

Detailed description: Despite the accumulating evidence supporting the favorable impact and potentially life-saving benefits of routine public mask wearing has on lowering the risk of COVID-19 transmission, recommendations for mask use have been met with resistance by some individuals. With the numerous health benefits greatly outweighing the document complaints of discomfort and headaches, it becomes puzzling why there is not universal support for these recommendations made by experts. Additional insight to this ongoing issue is provided in an extremely informative commentary provided by Scheid et al, in which they present theoretical evidence suggesting that there may be consequential psychological impacts of mask wearing on the basic psychological needs of competence, autonomy, and relatedness. Which may contribute to the controversy associated with mask use. It is also important to consider that such subjective experiences caused by mask wearing have been demonstrated to be exacerbated when physical exertion is performed at intensities above activities of daily living, such as during incremental aerobic or resistance exercise.

Currently, the CDC identifies age \> 65, BMI \> 30, diabetes, smoking, chronic obstructive pulmonary disease, heart conditions, or an immunocompromised state as risk factors for severe illness from COVID-19. Research conducted by Barkley et al, revealed that university closure increased sedentary behavior in all study participants, but only decreased physical activity in individuals who were the most active pre-cancellation. Highlighting concerns that pandemic-related closure of facilities such as gyms, which are designed for physical activity may disproportionately impact a more active population. Increased sedentary behavior and reduced physical activity will likely exacerbate these known risk factors for severe illness from COVID-19, and contribute to overloading our healthcare systems . While it is still recommended that adults of all ages should achieve 150-300 minutes of moderate or 75-150 minutes of vigorous (or an equivalent combination) physical activity per week, along with at least 2 days per week of muscle strengthening activities. Unfortunately, evidence based guidelines have not yet been developed to guide universal mask use during exercise and sporting events.

In this proposed randomized controlled cross-over study, we aim to evaluate in non-COVID-19 infected and otherwise healthy young-to-middle aged adults whether compared with performing resistance exercise (RE) with no mask (NM), 1) are there effects of wearing a surgical mask on physiological or psychological responses during RE that limit peak force or work performed in an exercise session, and 2) does wearing a surgical mask during resistance exercise yield clinically relevant and dangerous absolute indications warranting early exercise termination. Isokinetic testing can be used to provide valid, reliable, objective measure of a muscle's performance and offers significant clinical controls to simulate a resistance training workout. The lever arm speed measuring muscular output by the participant can be adjusted depending on the desired number of repetitions or duration test performed. Various skeletal muscle metabolic systems could be stressed depending on the effort and duration of time under tension, making it an efficient and reliable method for the assessment of muscle performance under various environmental conditions, including wearing a mask during a resistance training workout. To our knowledge this is the first study to assess the effects of wearing protective nose and face covering on resistance exercise capacity, estimate arterial oxyhemoglobin saturation (SpO2), and degree of discomfort.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Study inclusion criteria required potential participants must be apparently healthy without a history of any chronic disease (including absence of exercise induced asthma),
* Asymptomatic and without previous positive COVID-19 test
* Demonstrate no orthopedic or medical limitation that could be the cause of exercise termination

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Evaluate the effects of wearing a surgical face mask while performing resistance exercise on average peak force and total work performed.
timeFrame: 1 week
Secondary outcomes:
measure: Identify changes in the level of discomfort experienced while wearing a surgical mask during resistance exercise.
timeFrame: 1 week
Other outcomes:
Locations:
city: Garfield Heights
country: United States
facility: Cleveland Clinic Sports Health
state: Ohio
Study officials:
affiliation: Staff Physician
name: Matthew Kampert
role: PRINCIPAL_INVESTIGATOR
References: