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

NCT05150613 | Completed DMC

• 1 other identifier: Syeda Rida Batool
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers

Keywords

Face masks; COVID-19; Maximal Test; Submaximal Test; Surgical mask; N95 mask

Outcome Measures

Primary Outcomes (2)

• 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.

  After 48 hours

Secondary Outcomes (3)

• 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

Study Arms (3)

Group A

OTHER

No Mask

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

Group B

OTHER

Surgical Mask

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

Group C

OTHER

N95 Mask

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

Interventions

No Mask OTHER

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.

Group A; Group B; Group C

Surgical Mask OTHER

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.

Group A; Group B; Group C

N95 Mask OTHER

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.

Group A; Group B; Group C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Riphah Rehabilitation Center

Islamabad, AL, 44000, Pakistan

Location

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 34091726 BACKGROUND

• 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.

  PMID: 33153145 BACKGROUND

• 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.

  PMID: 32632523 BACKGROUND

• 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.

  PMID: 33349641 BACKGROUND

• 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.

  PMID: 33626065 BACKGROUND

• 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.

  PMID: 33532062 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

N95 Respirators

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Suman Sheraz, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding method will be employed to limit possible participant influence on test results (anticipation bias)
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 9, 2021
• Study Start: December 27, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 15, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)