Physiological Impact of Cloth Mask During Exercise

Fatigue Clinical Trial

Official title:

Physiological Impact of Cloth Mask During Exercise

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04887714
• Other study ID #: MaskStudy
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2021
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: 551130618783
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy individuals

• active, non-active and athletic individuals;

Exclusion Criteria:

• preexisting chronic conditions

• obesity

• physical limitation precluding exercise.

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• Mask
Mask wearing

Locations

Country	Name	City	State
Brazil	General Hospital - School of Medicine - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perceived exertion ratings	assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)	immediately after the intervention
Primary	perceived exertion ratings	assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)	during the intervention
Secondary	oxygen consumption	assessed by cardiopulmonary test	immediately after the intervention
Secondary	spirometry/lung function (VeVCO2 Slope)	assessed by cardiopulmonary test	during the intervention
Secondary	spirometry/lung function (PetCO2)	assessed by cardiopulmonary test	during the intervention
Secondary	spirometry/lung function (OUES)	assessed by cardiopulmonary test	during the intervention
Secondary	spirometry/lung function (flow-volume loop)	assessed by cardiopulmonary test	during the intervention
Secondary	blood lactate	assessed by lactate analyzer	immediately after the intervention
Secondary	oxygen saturation	assessed by pulse oximetry	immediately after the intervention
Secondary	vertical jump	assessed by jump test	immediately after the intervention
Secondary	heart rate recovery	assessed by heart rate monitor	immediately after the intervention
Secondary	Scale of Measuring Subjective Perceptions to maskwearing	assessed by a scale (0 to 10, with higher values meaning more uncomfortable)	immediately after the intervention