Facemask Impact on Cardiorespiratory PerformanceNCT04963049
Effects of Facemask on Cardiorespiratory Performance
A study testing Protocol with Mask in people with Facemask Impact on Cardiorespiratory Performance, run by Faculdade de Motricidade Humana at 1 site in Portugal.
Trial summary
The purpose of the study is to explore whether using a surgical facemask impacts performance in response exercise below vs. above the ventilatory threshold (VT). The investigatores also aim to explore the impact of sexual dimorphism in the physiological response to exercise performed within these specific intensities. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Facemask Impact on Cardiorespiratory Performance
- What is being tested?
- Protocol with Mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePortugal
- Study dates
- 25 Oct 2020to 29 Apr 2021
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy 18 to 30 years old adults
Who cannot join
- Potential participants, with body mass index (BMI) > 24.9 kg.m2 will be excluded. Additional exclusionary criteria will include active smoking status, known metabolic disease, cardiovascular disease, respiratory disorders including asthma; and any orthopedic issues that would limit exercise performance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercising With a Facemask on Cardiorespiratory Performance at Intensities Below and Above the Ventilatory Threshold
The purpose of the study is to explore whether using a surgical facemask impacts performance in response exercise below vs. above the ventilatory threshold (VT). The investigatores also aim to explore the impact of sexual dimorphism in the physiological response to exercise performed within these specific intensities. Finally, the onvestigators intend to examine whether the effects of wearing a facemask affect physiological recovery at cessation of exercise
Read the detailed description
Tests will be carried out during the afternoon period (between 13.00 and 16.00 h), in a laboratory with an environmental temperature between 22 and 24 ºC and a relative humidity between 44 and 56%.
Each participant will be tested on 3 non-consecutive days. On the first day, a Graded Exercise Testin (GXT) will be performed, to measure VO2max and to enable the individualization of intensities according to the VT of each participant. (Silva et al., 2011). Then, in a randomized (computer generated algorithm) counterbalanced manner, all participants performed resting and standardized cycle-ergometer submaximal protocols on two different conditions (with and without facemask), within a 1-week period. On the first visit, body mass measurements will be taken, to the nearest 0.01 kg, on a digital scale (BG 42, Breuer GmbH, Söflinger, Germany) with the participants wearing light-weight clothes and no shoes. Measurements of standing height will be limited to the first visit and taken to the nearest 0.5 cm using a stadiometer. Body Mass index (BMI) will be calculated by dividing the participants' mass in kilograms by the square of their height in meters. Then, after a brief warm-up period, each participant will perform a maximal cycle-ergometer test consisting of a ramp protocol to volitional exhaustion.
One of our purposes is to determine the impact of exercising with a facemask on physiological recovery. For this reason, measurements, within each submaximal testing session (with and without a facemask), will be taken using a standardized timeline designed to allow measuring recovery postsubmaximal exercise and compare it with a resting baseline time point. Specifically, testing will begin with a 10-min resting period in the seated position (baseline). Subsequently, participants will exercise either without (control) or with (experimental) a surgical facemask at an intensity below the VT and recover for another 10 min. Then, each participant will exercise at an intensity above the VT until volitional exhaustion and this will be followed by 10 min of recovery.
- Being tested
- Protocol with Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol with MaskOther
Look at differences in group with facemask and no mask
| Study group | Role | What they receive |
|---|---|---|
| With Mask | Experimental | Not described Receives: Other: Protocol with Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in VO2max
Differences between the two groups in the vo2max and
Measured: 1 week
Differences in Heart Rate
Differences between the two groups in the Heart Rate
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start25 Oct 2020
- Primary completion30 Jan 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facemask Impact on Cardiorespiratory PerformanceStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Pedro Jesus, Faculdade de Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963049
- Sponsor's protocol ID
- 23/2021
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jesus JP, Gomes M, Dias-Goncalves A, Correia JM, Pezarat-Correia P, Mendonca GV. Effects of surgical masks on the responses to constant work-rate cycling performed at different intensity domains. Clin Physiol Funct Imaging. 2022 Jan;42(1):43-52. doi: 10.1111/cpf.12734. Epub 2021 Nov 20.
PubMed 34753208
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercising With a Facemask on Cardiorespiratory Performance at Intensities Below and Above the Ventilatory Threshold
- ClinicalTrials.gov ID
- NCT04963049
- Acronym / sponsor ID
- 23/2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 15 Jul 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.
The purpose of the study is to explore whether using a surgical facemask impacts performance in response exercise below vs. above the ventilatory threshold (VT). The investigatores also aim to explore the impact of sexual dimorphism in the physiological response to exercise performed within these specific intensities. Finally, the onvestigators intend to examine whether the effects of wearing a facemask affect physiological recovery at cessation of exercise
Detailed description
Tests will be carried out during the afternoon period (between 13.00 and 16.00 h), in a laboratory with an environmental temperature between 22 and 24 ºC and a relative humidity between 44 and 56%.
Each participant will be tested on 3 non-consecutive days. On the first day, a Graded Exercise Testin (GXT) will be performed, to measure VO2max and to enable the individualization of intensities according to the VT of each participant. (Silva et al., 2011). Then, in a randomized (computer generated algorithm) counterbalanced manner, all participants performed resting and standardized cycle-ergometer submaximal protocols on two different conditions (with and without facemask), within a 1-week period. On the first visit, body mass measurements will be taken, to the nearest 0.01 kg, on a digital scale (BG 42, Breuer GmbH, Söflinger, Germany) with the participants wearing light-weight clothes and no shoes. Measurements of standing height will be limited to the first visit and taken to the nearest 0.5 cm using a stadiometer. Body Mass index (BMI) will be calculated by dividing the participants' mass in kilograms by the square of their height in meters. Then, after a brief warm-up period, each participant will perform a maximal cycle-ergometer test consisting of a ramp protocol to volitional exhaustion.
One of our purposes is to determine the impact of exercising with a facemask on physiological recovery. For this reason, measurements, within each submaximal testing session (with and without a facemask), will be taken using a standardized timeline designed to allow measuring recovery postsubmaximal exercise and compare it with a resting baseline time point. Specifically, testing will begin with a 10-min resting period in the seated position (baseline). Subsequently, participants will exercise either without (control) or with (experimental) a surgical facemask at an intensity below the VT and recover for another 10 min. Then, each participant will exercise at an intensity above the VT until volitional exhaustion and this will be followed by 10 min of recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| With Mask | Experimental | Other: Protocol with Mask |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy 18 to 30 years old adults
Key exclusion criteria (1 listed)
- Potential participants, with body mass index (BMI) > 24.9 kg.m2 will be excluded. Additional exclusionary criteria will include active smoking status, known metabolic disease, cardiovascular disease, respiratory disorders including asthma; and any orthopedic issues that would limit exercise performance.
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 |
|---|---|---|
| Protocol with MaskLook at differences in group with facemask and no mask | Other | With Mask |
Primary outcome
Differences in VO2max
Time frame: 1 week
Differences between the two groups in the vo2max and
Differences in Heart Rate
Time frame: 1 week
Differences between the two groups in the Heart Rate
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 15 Jul 2021.
- Derived from this study: PubMed 34753208Jesus JP, Gomes M, Dias-Goncalves A, Correia JM, Pezarat-Correia P, Mendonca GV. Effects of surgical masks on the responses to constant work-rate cycling performed at different intensity domains. Clin Physiol Funct Imaging. 2022 Jan;42(1):43-52. doi: 10.1111/cpf.12734. Epub 2021 Nov 20.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol with Mask in people with Facemask Impact on Cardiorespiratory Performance, run by Faculdade de Motricidade Humana at 1 site in Portugal.
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 1 inclusion and 1 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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
Differences in VO2max (time frame: 1 week). 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 NCT04963049, which also lists 1 linked publication.
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 15 Jul 2021.