Individual Performance Analysis of Cardiopulmonary Exercise Testing / Maximal and Sub-maximal Exercise Testing With Different Face Masks
Sponsor study identifier
interventional
62
1 country
2
Study Start
December 27, 2021
Actual (reported)Primary Completion
August 1, 2022
Actual (reported)Study Completion
September 15, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2021
Actual (reported)December 9, 2021
Actual (reported)December 27, 2021
Actual (reported)August 1, 2022
Actual (reported)September 15, 2022
Actual (reported)6MWT (Marked Walking Course, Stop Watch)
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.
After 48 hours
Bruce Protocol (Treadmill)
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.
Modified Borg's Scale for Rate of Perceived Exertion (RPE) (Dyspnea Score)
After 1minute
Discomfort Perception Scale
After 2 minutes
Hecimovich-Peiffer-Harbaugh Exercise Exhaustion Scale
After 5minutes
No Mask
Surgical Mask
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible \& distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed \& inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale \& post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Riphah Rehabilitation Center
Islamabad, AL, 44000, Pakistan
Riphah International University
Islamabad, Federal, 44000, Pakistan
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.
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.
Suman Sheraz, PhD*
Riphah International University
62 participants (actual enrollment reported by the registry).
First Submitted
November 23, 2021
First Posted
December 9, 2021
Study Start
December 27, 2021
Actual (reported)Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts
After 48 hours
N95 Mask
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible \& distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed \& inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale \& post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible \& distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed \& inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale \& post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
August 1, 2022
Actual (reported)Study Completion
September 15, 2022
Actual (reported)Last Updated
October 12, 2022
Record last verified: 2022-10
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