Physiological Impact of Cloth Mask During Exercise

NCT04887714 | Unknown

• 1 other identifier: MaskStudy
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue

Outcome Measures

Primary Outcomes (2)

• perceived exertion ratings

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

  immediately after the intervention

• perceived exertion ratings

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

  during the intervention

Secondary Outcomes (10)

• oxygen consumption

  immediately after the intervention

• spirometry/lung function (VeVCO2 Slope)

  during the intervention

• spirometry/lung function (PetCO2)

  during the intervention

• spirometry/lung function (OUES)

  during the intervention

• spirometry/lung function (flow-volume loop)

  during the intervention

Study Arms (2)

Mask

EXPERIMENTAL

cloth mask wearing

Other: Mask

control

NO INTERVENTION

control, without mask.

Interventions

Mask OTHER

Mask wearing

Mask

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

General Hospital - School of Medicine - University of Sao Paulo

São Paulo, 05508-030, Brazil

Location

Related Publications (2)

• 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.

  PMID: 36877666 DERIVED

• Guardieiro 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.

  PMID: 36476970 DERIVED

MeSH Terms

Conditions

Fatigue

Interventions

Masks

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Bruno Gualano, PhD

CONTACT

551130618783; gualano@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 14, 2021
• Study Start: May 7, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)