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

R

Riphah International University

Status

Completed

Conditions

Healthy Volunteers

Treatments

Other: Surgical Mask
Other: No Mask
Other: N95 Mask

Study type

Interventional

Funder types

Other

Identifiers

NCT05150613
Syeda Rida Batool

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

62 participants in 3 patient groups

Group A
Other group
Description:
No Mask
Treatment:
Other: N95 Mask
Other: Surgical Mask
Other: No Mask
Group B
Other group
Description:
Surgical Mask
Treatment:
Other: N95 Mask
Other: Surgical Mask
Other: No Mask
Group C
Other group
Description:
N95 Mask
Treatment:
Other: N95 Mask
Other: Surgical Mask
Other: No Mask

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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