Healthy VolunteersNCT05150613
Impact of Different Face Masks on Maximal and Submaximal Performance Testing During COVID-19
A study testing No Mask, Surgical Mask and N95 Mask in people with Healthy Volunteers, run by Riphah International University at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- No Mask, Surgical Mask and N95 Mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesPakistan
- Study dates
- 27 Dec 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Both genders
- Population from all age groups
- Healthy Individuals
- Physically active - screening through Get Active questionnaire
- Willing to consent
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Pakistan2 sites
Riphah Rehabilitation Center
Islamabad, AL, 44000
Riphah International University
Islamabad, Federal, 44000
About this study
Official title: Individual Performance Analysis of Cardiopulmonary Exercise Testing / Maximal and Sub-maximal Exercise Testing With Different Face Masks
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- No Mask, Surgical Mask, N95 Mask
- Keywords
- Face masks, COVID-19, Maximal Test, Submaximal Test, Surgical mask, N95 mask
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No MaskOther
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.
Surgical MaskOther
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.
N95 MaskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | No Mask Receives: Other: No Mask; Other: Surgical Mask; Other: N95 Mask |
| Group B | Other | Surgical Mask Receives: Other: No Mask; Other: Surgical Mask; Other: N95 Mask |
| Group C | Other | N95 Mask Receives: Other: No Mask; Other: Surgical Mask; Other: N95 Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 48 hours
Secondary outcomes (3)
Modified Borg's Scale for Rate of Perceived Exertion (RPE) (Dyspnea Score)
Modified Borg's scale is a validated and reliable outcome measure to rate subjective perception of exertion and breathlessness. A commonly employed tool used in cardiopulmonary rehabilitation to monitor progress in rehabilitation programs. Borg's scale, the modified version of the original scale proposed by Gunner, is mostly used in the diagnosis of effort-related dyspnea, chest pain, and musculoskeletal pain. The scale consists of a grading score from 0-10 (0; being no exertion at all to 10; being maximal). Subjective perception is rated during the activity. The chosen number from the numeric list denotes the intensity of activity allowing to speed up or slow down activity. The scale takes a few seconds to record responses and can be administered single or multiple times during the process.
Measured: After 1minute
Discomfort Perception Scale
The discomfort scale is utilized to rate subjective perception about ten sensations of discomfort (Humidity, heat, breathing resistance, itchiness, tightness, saltiness, feeling unfit, odor, fatigue, and overall discomfort). The scale has A 10-point rating scale for response record with 0 representing "none", 5 representing "acceptable" and 10 "very fond of." Low individual scores are indicative of low level of associated discomfort while high scores correspond to greater subjective discomfort perception.
Measured: After 2 minutes
Hecimovich-Peiffer-Harbaugh Exercise Exhaustion Scale
The post-exercise exhaustion scale is a validated and reliable tool to assess exercise-induced acute onset of exhaustion. The scale consists of 14 items that are measured by a 10-point Likert type frequency/intensity scale of response categories anchored at extreme ends by 'not at all to 'extremely difficult'. High scores are associated with elevated post-exercise exhaustion.
Measured: After 5minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start27 Dec 2021
- Primary completion1 Aug 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150613
- Sponsor's protocol ID
- Syeda Rida Batool
- Status last verified
- Oct 2022
- First submitted
- 23 Nov 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34091726Shaw 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.
PubMed 33153145Fikenzer 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.
PubMed 32632523Lassing 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.
PubMed 33349641Shein 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.
PubMed 33626065Swiatek 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.
PubMed 33532062
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Performance Analysis of Cardiopulmonary Exercise Testing / Maximal and Sub-maximal Exercise Testing With Different Face Masks
- ClinicalTrials.gov ID
- NCT05150613
- Acronym / sponsor ID
- Syeda Rida Batool
- Conditions
- Healthy Volunteers
- Keywords
- Face masks, COVID-19, Maximal Test, Submaximal Test, Surgical mask, N95 mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: No Mask, Other: Surgical Mask, Other: N95 MaskNo Mask |
| Group B | Other | Other: No Mask, Other: Surgical Mask, Other: N95 MaskSurgical Mask |
| Group C | Other | Other: No Mask, Other: Surgical Mask, Other: N95 MaskN95 Mask |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Both genders
- Population from all age groups
- Healthy Individuals
- Physically active - screening through Get Active questionnaire
- Willing to consent
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No MaskParticipants 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. | Other | Group A, Group B, Group C |
| Surgical MaskParticipants 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. | Other | Group A, Group B, Group C |
| N95 MaskParticipants 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. | Other | Group A, Group B, Group C |
Primary outcome
6MWT (Marked Walking Course, Stop Watch)
Time frame: After 48 hours
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.
Bruce Protocol (Treadmill)
Time frame: After 48 hours
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.
3 secondary outcomes
Modified Borg's Scale for Rate of Perceived Exertion (RPE) (Dyspnea Score)
Time frame: After 1minute
Discomfort Perception Scale
Time frame: After 2 minutes
Hecimovich-Peiffer-Harbaugh Exercise Exhaustion Scale
Time frame: After 5minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background: PubMed 34091726Egger 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.
- Background: PubMed 33153145Shaw 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.
- Background: PubMed 32632523Fikenzer 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.
- Background: PubMed 33349641Lassing 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.
- Background: PubMed 33626065Shein 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.
- Background: PubMed 33532062Swiatek 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sheraz, PhD* principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Mask, Surgical Mask and N95 Mask in people with Healthy Volunteers, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWT (Marked Walking Course, Stop Watch) (time frame: After 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150613, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.