Physiological Impact of Cloth Mask During Exercise

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 Overview

• Status: Not yet recruiting
• Conditions: Fatigue
• Intervention / Treatment: Other: Mask

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Gualano, PhD; Phone Number: 551130618783; Email: gualano@usp.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-030
    • General Hospital - School of Medicine - University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mask; cloth mask wearing	Other: Mask; Mask wearing
No Intervention: control; control, without mask.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen consumption	assessed by cardiopulmonary test	immediately after the intervention
spirometry/lung function (VeVCO2 Slope)	assessed by cardiopulmonary test	during the intervention
spirometry/lung function (PetCO2)	assessed by cardiopulmonary test	during the intervention
spirometry/lung function (OUES)	assessed by cardiopulmonary test	during the intervention
spirometry/lung function (flow-volume loop)	assessed by cardiopulmonary test	during the intervention
blood lactate	assessed by lactate analyzer	immediately after the intervention
oxygen saturation	assessed by pulse oximetry	immediately after the intervention
vertical jump	assessed by jump test	immediately after the intervention
heart rate recovery	assessed by heart rate monitor	immediately after the intervention
Scale of Measuring Subjective Perceptions to maskwearing	assessed by a scale (0 to 10, with higher values meaning more uncomfortable)	immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): May 7, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: MaskStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be make available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No