FatigueNCT04887714
Physiological Impact of Cloth Mask During Exercise
A study testing Mask in people with Fatigue, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Mask wearing during the Covid-19 pandemic has been proven substantially effective in containing the spread of infection, with cloth masks being the most universally used. However, cloth masks may be uncomfortable and have physiological repercussion during exercise. Read more about this study
- Who is it for?
- Ages 10 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- 7 May 2021to 1 Dec 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 10 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy individuals
- active, non-active and athletic individuals;
Who cannot join
- preexisting chronic conditions
- obesity
- physical limitation precluding exercise.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital - School of Medicine - University of Sao Paulo
São Paulo, 05508-030
About this study
Mask wearing during the Covid-19 pandemic has been proven substantially effective in containing the spread of infection, with cloth masks being the most universally used. However, cloth masks may be uncomfortable and have physiological repercussion during exercise. This study aims to investigate the impact of cloth masks during exercise.
- Conditions
- Fatigue
- Being tested
- Mask
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaskOther
Mask wearing
| Study group | Role | What they receive |
|---|---|---|
| Mask | Experimental | cloth mask wearing Receives: Other: Mask |
| control | No intervention | control, without mask. |
What is being measured
The primary outcome is the main question the study is designed to answer.
perceived exertion ratings
assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)
Measured: immediately after the intervention
perceived exertion ratings
assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)
Measured: during the intervention
Secondary outcomes (10)
oxygen consumption
assessed by cardiopulmonary test
Measured: immediately after the intervention
spirometry/lung function (VeVCO2 Slope)
assessed by cardiopulmonary test
Measured: during the intervention
spirometry/lung function (PetCO2)
assessed by cardiopulmonary test
Measured: during the intervention
spirometry/lung function (OUES)
assessed by cardiopulmonary test
Measured: during the intervention
spirometry/lung function (flow-volume loop)
assessed by cardiopulmonary test
Measured: during the intervention
blood lactate
assessed by lactate analyzer
Measured: immediately after the intervention
oxygen saturation
assessed by pulse oximetry
Measured: immediately after the intervention
vertical jump
assessed by jump test
Measured: immediately after the intervention
heart rate recovery
assessed by heart rate monitor
Measured: immediately after the intervention
Scale of Measuring Subjective Perceptions to maskwearing
assessed by a scale (0 to 10, with higher values meaning more uncomfortable)
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start7 May 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887714
- Sponsor's protocol ID
- MaskStudy
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be make available upon reasonable request.
Publications
Marticorena FM, Barreto GC, Guardieiro NM, Esteves GP, Oliveira TN, de Oliveira LF, Pinto ALS, Riani L, Prado DM, Saunders B, Gualano B. Performing moderate to severe activity is safe and tolerable for healthy youth while wearing a cloth facemask. PLoS One. 2023 Mar 6;18(3):e0282475. doi: 10.1371/journal.pone.0282475. eCollection 2023.
PubMed 36877666Guardieiro NM, Barreto G, Marticorena FM, Nunes Oliveira T, de Oliveira LF, Pinto ALS, Prado DMLD, Saunders B, Gualano B. A Cloth Facemask Causes No Major Respiratory or Cardiovascular Perturbations During Moderate to Heavy Exercise. J Phys Act Health. 2022 Dec 7;20(1):35-44. doi: 10.1123/jpah.2022-0145. Print 2023 Jan 1.
PubMed 36476970
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Impact of Cloth Mask During Exercise
- ClinicalTrials.gov ID
- NCT04887714
- Acronym / sponsor ID
- MaskStudy
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 7 May 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 14 May 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.
Mask wearing during the Covid-19 pandemic has been proven substantially effective in containing the spread of infection, with cloth masks being the most universally used. However, cloth masks may be uncomfortable and have physiological repercussion during exercise. This study aims to investigate the impact of cloth masks during exercise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mask | Experimental | Other: Maskcloth mask wearing |
| control | No intervention | –control, without mask. |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- healthy individuals
- active, non-active and athletic individuals;
Key exclusion criteria (3 listed)
- preexisting chronic conditions
- obesity
- physical limitation precluding exercise.
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 |
|---|---|---|
| MaskMask wearing | Other | Mask |
Primary outcome
perceived exertion ratings
Time frame: immediately after the intervention
assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)
perceived exertion ratings
Time frame: during the intervention
assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)
10 secondary outcomes
oxygen consumption
Time frame: immediately after the intervention
spirometry/lung function (VeVCO2 Slope)
Time frame: during the intervention
spirometry/lung function (PetCO2)
Time frame: during the intervention
spirometry/lung function (OUES)
Time frame: during the intervention
spirometry/lung function (flow-volume loop)
Time frame: during the intervention
blood lactate
Time frame: immediately after the intervention
oxygen saturation
Time frame: immediately after the intervention
vertical jump
Time frame: immediately after the intervention
heart rate recovery
Time frame: immediately after the intervention
Scale of Measuring Subjective Perceptions to maskwearing
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 36877666Marticorena FM, Barreto GC, Guardieiro NM, Esteves GP, Oliveira TN, de Oliveira LF, Pinto ALS, Riani L, Prado DM, Saunders B, Gualano B. Performing moderate to severe activity is safe and tolerable for healthy youth while wearing a cloth facemask. PLoS One. 2023 Mar 6;18(3):e0282475. doi: 10.1371/journal.pone.0282475. eCollection 2023.
- Derived from this study: PubMed 36476970Guardieiro NM, Barreto G, Marticorena FM, Nunes Oliveira T, de Oliveira LF, Pinto ALS, Prado DMLD, Saunders B, Gualano B. A Cloth Facemask Causes No Major Respiratory or Cardiovascular Perturbations During Moderate to Heavy Exercise. J Phys Act Health. 2022 Dec 7;20(1):35-44. doi: 10.1123/jpah.2022-0145. Print 2023 Jan 1.
- Individual participant dataSharing planned: No. IPD will be make available upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask in people with Fatigue, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 May 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, PhD (551130618783, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perceived exertion ratings (time frame: immediately after the intervention). 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 NCT04887714, which also lists 2 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 14 May 2021.