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

NCT04706299 | Completed

• 1 other identifier: 20-1303
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention of COVID-19

Keywords

Exercise; Face Mask; COVID-19; Resistance Training

Outcome Measures

Primary Outcomes (1)

• Evaluate the effects of wearing a surgical face mask while performing resistance exercise on average peak force and total work performed.

  For this we will utilize the Biodex system to measure average peak torque (highest force output in a repetition) and total work (muscle's cumulative ability to produce force throughout range of motion for the entire set of repetitions). Working Hypothesis: There will not be a statistically significant difference of peak torque and total work while wearing a mask compared without a mask.

  1 week

Secondary Outcomes (1)

• Identify changes in the level of discomfort experienced while wearing a surgical mask during resistance exercise.

  1 week

Study Arms (2)

No Mask

ACTIVE COMPARATOR

Will not wear a mask

Other: Resistance Exercise

Surgical mask

EXPERIMENTAL

Will wear a surgical nose and face covering

Other: Resistance Exercise

Interventions

Resistance Exercise 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.

No Mask; Surgical mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Asymptomatic and without previous positive COVID-19 test
• Demonstrate no orthopedic or medical limitation that could be the cause of exercise termination

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Sports Health

Garfield Heights, Ohio, 44125, United States

Location

MeSH Terms

Conditions

Motor Activity; COVID-19

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Matthew Kampert

  Staff Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will perform a RE protocol under 2 different conditions, once without a mask and once while wearing a surgical mask. A coin flip wil be utlize to minimize the possibility of familiarization or training effects, and maintain complete randomness of the assignment of which RE conditions is performed first, in addition to which leg is tested first. This simple randomization method to determine the assignment will follow (heads = No mask, tails = surgical mask and heads = dominant leg 1st, tails = nondominant leg 1st, on the 1st and 2nd coin toss, respectively). Study participants will be asked which leg they prefer to kick a ball with to identify their dominant leg for data collection purposes
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 12, 2021
• Study Start: January 12, 2021
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)