Back to resultsPhysiological Impact of Cloth Mask During Exercise
Primary Purpose
Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mask
Sponsored by
About this trial
This is an interventional other trial for Fatigue
Eligibility Criteria
Inclusion Criteria:
- healthy individuals
- active, non-active and athletic individuals;
Exclusion Criteria:
- preexisting chronic conditions
- obesity
- physical limitation precluding exercise.
Sites / Locations
- General Hospital - School of Medicine - University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mask
control
Arm Description
cloth mask wearing
control, without mask.
Outcomes
Primary Outcome Measures
perceived exertion ratings
assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)
perceived exertion ratings
assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)
Secondary Outcome Measures
oxygen consumption
assessed by cardiopulmonary test
spirometry/lung function (VeVCO2 Slope)
assessed by cardiopulmonary test
spirometry/lung function (PetCO2)
assessed by cardiopulmonary test
spirometry/lung function (OUES)
assessed by cardiopulmonary test
spirometry/lung function (flow-volume loop)
assessed by cardiopulmonary test
blood lactate
assessed by lactate analyzer
oxygen saturation
assessed by pulse oximetry
vertical jump
assessed by jump test
heart rate recovery
assessed by heart rate monitor
Scale of Measuring Subjective Perceptions to maskwearing
assessed by a scale (0 to 10, with higher values meaning more uncomfortable)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04887714
Brief Title
Physiological Impact of Cloth Mask During Exercise
Official Title
Physiological Impact of Cloth Mask During Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mask
Arm Type
Experimental
Arm Description
cloth mask wearing
Arm Title
control
Arm Type
No Intervention
Arm Description
control, without mask.
Intervention Type
Other
Intervention Name(s)
Mask
Intervention Description
Mask wearing
Primary Outcome Measure Information:
Title
perceived exertion ratings
Description
assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)
Time Frame
immediately after the intervention
Title
perceived exertion ratings
Description
assessed by a scale (7 to 20, with higher values meaning higher perceived exertion)
Time Frame
during the intervention
Secondary Outcome Measure Information:
Title
oxygen consumption
Description
assessed by cardiopulmonary test
Time Frame
immediately after the intervention
Title
spirometry/lung function (VeVCO2 Slope)
Description
assessed by cardiopulmonary test
Time Frame
during the intervention
Title
spirometry/lung function (PetCO2)
Description
assessed by cardiopulmonary test
Time Frame
during the intervention
Title
spirometry/lung function (OUES)
Description
assessed by cardiopulmonary test
Time Frame
during the intervention
Title
spirometry/lung function (flow-volume loop)
Description
assessed by cardiopulmonary test
Time Frame
during the intervention
Title
blood lactate
Description
assessed by lactate analyzer
Time Frame
immediately after the intervention
Title
oxygen saturation
Description
assessed by pulse oximetry
Time Frame
immediately after the intervention
Title
vertical jump
Description
assessed by jump test
Time Frame
immediately after the intervention
Title
heart rate recovery
Description
assessed by heart rate monitor
Time Frame
immediately after the intervention
Title
Scale of Measuring Subjective Perceptions to maskwearing
Description
assessed by a scale (0 to 10, with higher values meaning more uncomfortable)
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy individuals
active, non-active and athletic individuals;
Exclusion Criteria:
preexisting chronic conditions
obesity
physical limitation precluding exercise.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Gualano, PhD
Phone
551130618783
Email
gualano@usp.br
Facility Information:
Facility Name
General Hospital - School of Medicine - University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-030
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be make available upon reasonable request.
Learn more about this trial
Physiological Impact of Cloth Mask During Exercise
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