Treadmill Stress Test With and Without Mask (TREADMASK)

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Treadmill test (Bruce protocol)

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Warner Mampuya, MD, PhD, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): June 16, 2021
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Adults; Healthy; COVID-19; Mask; Treadmill; METS; Stress test; Bruce; Metabolic equivalent; Borg
• Other Study ID Numbers: 2021-4210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underlies results in a publication will be available in the supplementary appendix of the publication or on request.
• IPD Sharing Time Frame: The data will be available at the time of the publication and for the 2 following years.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No