- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963049
Effects of Facemask on Cardiorespiratory Performance
Effects of Exercising With a Facemask on Cardiorespiratory Performance at Intensities Below and Above the Ventilatory Threshold
Study Overview
Status
Intervention / Treatment
Detailed Description
Tests will be carried out during the afternoon period (between 13.00 and 16.00 h), in a laboratory with an environmental temperature between 22 and 24 ºC and a relative humidity between 44 and 56%.
Each participant will be tested on 3 non-consecutive days. On the first day, a Graded Exercise Testin (GXT) will be performed, to measure VO2max and to enable the individualization of intensities according to the VT of each participant. (Silva et al., 2011). Then, in a randomized (computer generated algorithm) counterbalanced manner, all participants performed resting and standardized cycle-ergometer submaximal protocols on two different conditions (with and without facemask), within a 1-week period. On the first visit, body mass measurements will be taken, to the nearest 0.01 kg, on a digital scale (BG 42, Breuer GmbH, Söflinger, Germany) with the participants wearing light-weight clothes and no shoes. Measurements of standing height will be limited to the first visit and taken to the nearest 0.5 cm using a stadiometer. Body Mass index (BMI) will be calculated by dividing the participants' mass in kilograms by the square of their height in meters. Then, after a brief warm-up period, each participant will perform a maximal cycle-ergometer test consisting of a ramp protocol to volitional exhaustion.
One of our purposes is to determine the impact of exercising with a facemask on physiological recovery. For this reason, measurements, within each submaximal testing session (with and without a facemask), will be taken using a standardized timeline designed to allow measuring recovery postsubmaximal exercise and compare it with a resting baseline time point. Specifically, testing will begin with a 10-min resting period in the seated position (baseline). Subsequently, participants will exercise either without (control) or with (experimental) a surgical facemask at an intensity below the VT and recover for another 10 min. Then, each participant will exercise at an intensity above the VT until volitional exhaustion and this will be followed by 10 min of recovery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cruz Quebrada
-
Oeiras, Cruz Quebrada, Portugal, 1495-751
- Faculdade Motricidade Humana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy 18 to 30 years old adults
Exclusion Criteria:
- Potential participants, with body mass index (BMI) > 24.9 kg.m2 will be excluded. Additional exclusionary criteria will include active smoking status, known metabolic disease, cardiovascular disease, respiratory disorders including asthma; and any orthopedic issues that would limit exercise performance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: With Mask
|
Look at differences in group with facemask and no mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in VO2max
Time Frame: 1 week
|
Differences between the two groups in the vo2max and
|
1 week
|
|
Differences in Heart Rate
Time Frame: 1 week
|
Differences between the two groups in the Heart Rate
|
1 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 23/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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