Clinical trial NCT05150613: Impact of Different Face Masks on Maximal and Submaximal Performance Testing During COVID-19
Official title: Individual Performance Analysis of Cardiopulmonary Exercise Testing / Maximal and Sub-maximal Exercise Testing With Different Face Masks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Face masks
COVID-19
Maximal Test
Submaximal Test
Surgical mask
N95 mask
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: 6MWT (Marked Walking Course, Stop Watch)
timeFrame: After 48 hours
measure: Bruce Protocol (Treadmill)
timeFrame: After 48 hours
Secondary outcomes:
measure: Modified Borg's Scale for Rate of Perceived Exertion (RPE) (Dyspnea Score)
timeFrame: After 1minute
measure: Discomfort Perception Scale
timeFrame: After 2 minutes
measure: Hecimovich-Peiffer-Harbaugh Exercise Exhaustion Scale
timeFrame: After 5minutes
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah Rehabilitation Center
state: AL
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Suman Sheraz, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Egger F, Blumenauer D, Fischer P, Venhorst A, Kulenthiran S, Bewarder Y, Zimmer A, Bohm M, Meyer T, Mahfoud F. Effects of face masks on performance and cardiorespiratory response in well-trained athletes. Clin Res Cardiol. 2022 Mar;111(3):264-271. doi: 10.1007/s00392-021-01877-0. Epub 2021 Jun 6.
citation: Shaw K, Butcher S, Ko J, Zello GA, Chilibeck PD. Wearing of Cloth or Disposable Surgical Face Masks has no Effect on Vigorous Exercise Performance in Healthy Individuals. Int J Environ Res Public Health. 2020 Nov 3;17(21):8110. doi: 10.3390/ijerph17218110.
citation: Fikenzer S, Uhe T, Lavall D, Rudolph U, Falz R, Busse M, Hepp P, Laufs U. Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clin Res Cardiol. 2020 Dec;109(12):1522-1530. doi: 10.1007/s00392-020-01704-y. Epub 2020 Jul 6.
citation: Lassing J, Falz R, Pokel C, Fikenzer S, Laufs U, Schulze A, Holldobler N, Rudrich P, Busse M. Effects of surgical face masks on cardiopulmonary parameters during steady state exercise. Sci Rep. 2020 Dec 21;10(1):22363. doi: 10.1038/s41598-020-78643-1.
citation: Shein SL, Whitticar S, Mascho KK, Pace E, Speicher R, Deakins K. The effects of wearing facemasks on oxygenation and ventilation at rest and during physical activity. PLoS One. 2021 Feb 24;16(2):e0247414. doi: 10.1371/journal.pone.0247414. eCollection 2021.
citation: Swiatek KM, Lester C, Ng N, Golia S, Pinson J, Grinnan D. Impact of Face Masks on 6-Minute Walk Test in Healthy Volunteers. Pulm Circ. 2021 Jan 20;11(1):2045894020988437. doi: 10.1177/2045894020988437. eCollection 2021 Jan-Mar.