Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05150613
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2021-11-23
Brief Title:
Impact of Different Face Masks on Maximal and Submaximal Performance Testing During COVID-19
Sponsor:
Riphah International University
Organization:
Riphah International University
Study Overview
Official Title:
Individual Performance Analysis of Cardiopulmonary Exercise Testing Maximal and Sub-maximal Exercise Testing With Different Face Masks
Status:
COMPLETED
Status Verified Date:
2022-10
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:
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
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 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