Effects of Surgical Mask Use on Peak Torque, Total Work and Interset Fatigability During Isokinetic Strength Testing

NCT ID: NCT04706299

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2021-05-21

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.

Conditions

Prevention of COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

No Mask

Will not wear a mask

Group Type: ACTIVE_COMPARATOR

Resistance Exercise

Intervention Type: OTHER

Participants will perform for each leg, 3 sets comprised of 15 repetitions set to 180 degrees per second of an isokinetic, concentric knee extension and flexion. Resulting in a 20 second long working set (10 seconds extension, 10 seconds flexion), per set. Each set will be followed by a 90 second period of recovery. After completing 3 sets on initial leg, testing will be set up for second leg.

Surgical mask

Will wear a surgical nose and face covering

Group Type: EXPERIMENTAL

Resistance Exercise

Intervention Type: OTHER

Participants will perform for each leg, 3 sets comprised of 15 repetitions set to 180 degrees per second of an isokinetic, concentric knee extension and flexion. Resulting in a 20 second long working set (10 seconds extension, 10 seconds flexion), per set. Each set will be followed by a 90 second period of recovery. After completing 3 sets on initial leg, testing will be set up for second leg.

Interventions

Resistance Exercise

Participants will perform for each leg, 3 sets comprised of 15 repetitions set to 180 degrees per second of an isokinetic, concentric knee extension and flexion. Resulting in a 20 second long working set (10 seconds extension, 10 seconds flexion), per set. Each set will be followed by a 90 second period of recovery. After completing 3 sets on initial leg, testing will be set up for second leg.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age > 18
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Matthew Kampert

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Kampert

Role: PRINCIPAL_INVESTIGATOR

Staff Physician

Locations

Cleveland Clinic Sports Health

Garfield Heights, Ohio, United States

Countries

United States

Other Identifiers

20-1303

Identifier Type: -

Identifier Source: org_study_id