CClinicalTrials.gg
Status unknownNCT04887714Updated May 14, 2021

Physiological Impact of Cloth Mask During Exercise

An interventional study of Mask in Fatigue, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 10 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
10 Years to 45 Years
Sex
All
01

Study 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. This study aims to investigate the impact of cloth masks during exercise.

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Conditions studied

  • Fatigue

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03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 68 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy individuals
  • active, non-active and athletic individuals;

Exclusion criteria

Exclusion Criteria:

  • preexisting chronic conditions
  • obesity
  • physical limitation precluding exercise.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Mask

    cloth mask wearing

    Other: Mask

  • No intervention
    control

    control, without mask.

Interventions

  • OtherMask

    Mask wearing

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What researchers measure

Primary outcomes

  1. perceived exertion ratings

    assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)

    Time frame: immediately after the intervention

  2. perceived exertion ratings

    assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)

    Time frame: during the intervention

Secondary outcomes

  1. oxygen consumption

    assessed by cardiopulmonary test

    Time frame: immediately after the intervention

  2. spirometry/lung function (VeVCO2 Slope)

    assessed by cardiopulmonary test

    Time frame: during the intervention

  3. spirometry/lung function (PetCO2)

    assessed by cardiopulmonary test

    Time frame: during the intervention

  4. spirometry/lung function (OUES)

    assessed by cardiopulmonary test

    Time frame: during the intervention

  5. spirometry/lung function (flow-volume loop)

    assessed by cardiopulmonary test

    Time frame: during the intervention

  6. blood lactate

    assessed by lactate analyzer

    Time frame: immediately after the intervention

  7. oxygen saturation

    assessed by pulse oximetry

    Time frame: immediately after the intervention

  8. vertical jump

    assessed by jump test

    Time frame: immediately after the intervention

  9. heart rate recovery

    assessed by heart rate monitor

    Time frame: immediately after the intervention

  10. Scale of Measuring Subjective Perceptions to maskwearing

    assessed by a scale (0 to 10, with higher values meaning more uncomfortable)

    Time frame: immediately after the intervention

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Study locations

1 site
  • General Hospital - School of Medicine - University of Sao Paulo
    Sao Paulo, 05508-030, Brazil
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References and documents

Individual participant data

Plan to share: No — IPD will be make available upon reasonable request.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04887714
Lead sponsor
University of Sao Paulo
Responsible party
Bruno Gualano (Associate Professor, University of Sao Paulo) — Principal investigator
First posted
May 14, 2021
Start date
May 7, 2021 (estimated)
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
May 14, 2021

Study contacts

Bruno Gualano, PhD
Contact
gualano@usp.br
551130618783

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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