Impact of Different Face Masks on Maximal and Submaximal Performance Testing During COVID-19

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: No Mask; Other: Surgical Mask; Other: N95 Mask

• Registration Number: NCT05150613
• Lead Sponsor: Riphah International University

Brief Summary

In COVID 19, masks wearability has become a new normal and this "new normal" presented evidence-based performance limitations. The study findings are aimed to objectify parametric changes (if any) and therefore, will assist in making future decisions for testing programs with minimum limitation and maximum protection in this pandemic.

Detailed Description

Victimizing millions of individuals, the novel coronavirus (COVID-19) has made drastic changes in our lives including the obligation of personal protective equipment (PPEs), especially masks. This obligation presented evidence-based performance limitations owing to mask associated airflow resistance, increased ventilatory effort, external air trapping thus elevated carbon dioxide concentration and reuptake, thermal effects, and ventilatory parameters decline along with other physiological, psychological and health-related consequences.

Despite the reported success of vaccination, the use of PPEs especially face masks as one of the non-pharmacological solution to limit viral transmission is a controversial recommendation. With diameter difference between SARS-CoV-2 and mask threads makes viral transmission non-preventable, it however could be reduced partially from 67% to 17% due to the filtration barrier provided by face masks. With new research supporting viral transmission from asymptomatic individuals, the United States Centre of Disease Control (CDC) recommends the use of face masks in an indoor and outdoor setting requiring public interaction where social distancing is unrealistic.

Cardio Pulmonary Exercise Testing (CPET) is an important clinical tool to assess aerobic capacity and has value in predicting outcomes not only in cardiac diseased populations but in other conditions also. Being a gold standard for risk stratification and exercise prescription plans, its application sometimes becomes impractical and thus formulation and utilization of submaximal and graded exercises test proved fruitful in rehabilitation program design in terms of cost efficiency and little expertise requirement for performance. With pandemic in place, the procedure for exercise testing has changed from routine practice. The addition of masks during testing procedures, as per recommendations of CDC to avoid cross-contamination among the health care providers and the participating community, as aerosol generation during exercise testing as a consequence of frequent forceful respiration due to variable exercise intensities thus high discharge rates and farther viral spread.

Both submaximal (6MWT) and maximal (Bruce protocol) exercise tests are commonly used exercise tests in a health care setting with high prognostic and diagnostic values. As per knowledge, there is limited evidence available on testing procedure and therefore the plan is to cover the gaps identified in previous research based on 6MWT and Bruce protocol (mask variability, sample modesty, age restrictions; data on young healthy individuals, few analyzed testing parameters) and note the performance differences if achieved to guide the formulation of structured and standardized approach towards both testing procedures using medically acceptable masks as a general requirement for future testing. As no guidelines had yet been issued to adapt the testing to current situations with PPEs. Analysis of parametric changes in healthy volunteers would aid in the formulation of a recommendation plan for performance analysis measures used in cardiopulmonary settings to ensure minimum performance limitation with added equipment and maintenance of consistency in adaptive testing.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-09
• Study Start: 2021-12-27
• Primary Completion: 2022-08-01
• Study Completion: 2022-09-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Both genders
• Population from all age groups
• Healthy Individuals
• Physically active - screening through Get Active questionnaire
• Willing to consent

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Exclusion Criteria

• Cognitively Impaired
• Participants with absolute or relative contraindication to exercise testing
• Underlying condition limiting mask wearability
• Communication gap (language other than Urdu or English)
• Subjects performing regular physical activity (sports personal)
• Latent known/diagnosed disease condition
• People with Long Covid (evaluated via self-reported Post COVID-19 Functional Status Scale)
• Patients with laboratory diagnosed and symptomatic COVID-19

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	N95 Mask	No Mask
Group B	Surgical Mask	Surgical Mask
Group C	No Mask	N95 Mask
Group A	No Mask	No Mask
Group C	Surgical Mask	N95 Mask
Group B	No Mask	Surgical Mask
Group A	Surgical Mask	No Mask
Group B	N95 Mask	Surgical Mask
Group C	N95 Mask	N95 Mask

Primary Outcome Measures

Name	Time	Method
6MWT (Marked Walking Course, Stop Watch)	After 48 hours	6mwt is a submaximal testing procedure developed by the American Thoracic Society to assess aerobic capacity, endurance, and changes in performance capacity. The test measures the distance covered in 6 Minutes and is intended for all populations with a wide range of diagnoses. The procedure requires a 30-meter unimpeded walkway, a timer, distance markers, turning pointers (cones) and monitoring gadgets (oximeter, Borg's scale), and chairs for the resting period (on requirement). The participants are instructed to walk as much as possible with minimum rests and regular standardized encouragements are provided throughout the test. The distance at the end is recorded along with the number of stops during the test and other parameters. Low distance scores are indicative of reduced performance capacity.; It will be used for sub maximal testing of participants with no mask, surgical mask and wearing N95 mask with the minimum wash out period of 48 hours.
Bruce Protocol (Treadmill)	After 48 hours	The standard Bruce protocol is the most preferred exercise stress test with validated outcomes and good prognostic values. It is a standard test in cardiology and is divided into successive stages of 3 minutes with an abrupt increase in speed and inclination by the end of each 3-minute cycle. Bruce protocol has 7 stages with starting speed of 1.7 miles/h at 10% inclination (2% inclination increase/stage). The speed change follows as; Level 2 (2.5 miles/h), level 3 (3.4 miles/h), level 4 (4.2 miles/h), level 5 (5.0 miles/h), level 6 (5.5 miles/h) and level 7 (6.0 miles/h) respectively. The participants are advised to perform the test till exhaustion, or the test is suspended based on unlikely events. It will be used for maximal testing of participants with no mask, surgical mask and wearing N95 mask with the minimum wash out period of 48 hours.

Secondary Outcome Measures

Name	Time	Method
Modified Borg's Scale for Rate of Perceived Exertion (RPE) (Dyspnea Score)	After 1minute	Modified Borg's scale is a validated and reliable outcome measure to rate subjective perception of exertion and breathlessness. A commonly employed tool used in cardiopulmonary rehabilitation to monitor progress in rehabilitation programs. Borg's scale, the modified version of the original scale proposed by Gunner, is mostly used in the diagnosis of effort-related dyspnea, chest pain, and musculoskeletal pain. The scale consists of a grading score from 0-10 (0; being no exertion at all to 10; being maximal). Subjective perception is rated during the activity. The chosen number from the numeric list denotes the intensity of activity allowing to speed up or slow down activity. The scale takes a few seconds to record responses and can be administered single or multiple times during the process.
Discomfort Perception Scale	After 2 minutes	The discomfort scale is utilized to rate subjective perception about ten sensations of discomfort (Humidity, heat, breathing resistance, itchiness, tightness, saltiness, feeling unfit, odor, fatigue, and overall discomfort). The scale has A 10-point rating scale for response record with 0 representing "none", 5 representing "acceptable" and 10 "very fond of." Low individual scores are indicative of low level of associated discomfort while high scores correspond to greater subjective discomfort perception.
Hecimovich-Peiffer-Harbaugh Exercise Exhaustion Scale	After 5minutes	The post-exercise exhaustion scale is a validated and reliable tool to assess exercise-induced acute onset of exhaustion. The scale consists of 14 items that are measured by a 10-point Likert type frequency/intensity scale of response categories anchored at extreme ends by 'not at all to 'extremely difficult'. High scores are associated with elevated post-exercise exhaustion.

Trial Locations

Locations (2)

Riphah Rehabilitation Center; 🇵🇰 Islamabad, AL, Pakistan

Riphah International University; 🇵🇰 Islamabad, Federal, Pakistan