Treadmill Stress Test With and Without Mask

Study Overview
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Brief Summary
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The purpose of this study is to assess if wearing a surgical mask affects the results of a standard treadmill test.

Detailed Description
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The persons interested to participate will be informed of the implication and potential risks associated with the study. The participants that accept and meet the eligibility criteria will give written consent and be randomized into two groups. One group will first perform a treadmill test with a surgical mask and then repeat the test without a mask. The second group will do the first treadmill test without a mask and the second one with a surgical mask.

Official Title
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Treadmill Stress Test With and Without Mask: Comparison of Exercise Capacity and Perception

Conditions
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Healthy

Intervention / Treatment
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* Diagnostic Test: Treadmill test (Bruce protocol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18-65 years old) Healthy Vaccinated against COVID-19 Exclusion Criteria: Any cardiac or respiratory condition Walking difficulty Waiting for a stress test for a medical reason Abnormal resting ECG Inability to wear a mask Inability to understand or follow the instructions Medical contraindication to performing a treadmill stress test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With, then without a mask<br>Participants will first perform a treadmill test with a mask and 48 hours or more later will perform another similar treadmill test without a mask. | Diagnostic Test: Treadmill test (Bruce protocol)<br>* Treadmill test performed with and without a mask.<br>|
| Experimental: Without, then with a mask<br>Participants will first perform a treadmill test without a mask and 48 hours or more later will perform another similar treadmill test with a mask. | Diagnostic Test: Treadmill test (Bruce protocol)<br>* Treadmill test performed with and without a mask.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Metabolic Equivalents With vs Without a Mask | The maximal metabolic equivalents achieved will be calculated for each treadmill test performed. | Through study completion, an average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Borg's Category-Ratio Scale for Rating of Perceived Exertion With vs Without a Mask | The Borg Scale is a self-reporting instrument assessing intensity of perceived exertion on a 0 to 10 scale, 0 being rest and 10 maximal effort. | Through study completion, an average of 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Borg, Exercise, Stress test, Treadmill, Bruce, COVID-19, Mask, Healthy, Adults, METS, Metabolic equivalent