TREADMASK: Treadmill Stress Test With and Without Mask

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT04891120

Collaborator

(none)

Enrollment

Location

Arms

1.2

Actual Duration (Months)

29.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Diagnostic Test: Treadmill test (Bruce protocol)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Masking Description:

The statistician will be masked.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 11, 2021

Actual Primary Completion Date :

Jun 16, 2021

Actual Study Completion Date :

Jun 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: With, then without a mask 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) Treadmill test performed with and without a mask.
Experimental: Without, then with a mask 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) Treadmill test performed with and without a mask.

Arm

Intervention/Treatment

Experimental: With, then without a mask

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)

Treadmill test performed with and without a mask.

Experimental: Without, then with a mask

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)

Treadmill test performed with and without a mask.

Outcome Measures

Primary Outcome Measures

Change in Metabolic Equivalents With vs Without a Mask [Through study completion, an average of 1 week]
The maximal metabolic equivalents achieved will be calculated for each treadmill test performed.

Secondary Outcome Measures

Change in Borg's Category-Ratio Scale for Rating of Perceived Exertion With vs Without a Mask [Through study completion, an average of 1 week]
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.

Other Outcome Measures

Change in Exercise Duration With vs Without a Mask [Through study completion, an average of 1 week]
Change in Heart Rate During Exercise With vs Without a Mask [Through study completion, an average of 1 week]
Change in Blood Pressure During Exercise With vs Without a Mask [Through study completion, an average of 1 week]
Change in Oxygen Saturation During Exercise With vs Without a Mask [Through study completion, an average of 1 week]
Change in Duration of Exercise Before Reaching 85% of Predicted Maximal Heart Rate With vs Without a Mask [Through study completion, an average of 1 week]
Change in Calculated Maximal Oxygen Consumption During Exercise With vs Without a Mask [Through study completion, an average of 1 week]