Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706299
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2021-01-10
Brief Title:
Effects of Surgical Mask Use on Peak Torque Total Work and Interset Fatigability During Isokinetic Strength Testing
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Effects of Surgical Mask Use on Peak Torque Total Work and Interset Fatigability During Isokinetic Strength Testing
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 18 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 muscles 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
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 muscles 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None