Treadmill Stress Test With and Without Mask

Healthy Clinical Trial

— TREADMASK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891120
• Other study ID #: 2021-4210
• Status: Completed
• Phase: N/A
• Start date: May 11, 2021
• Est. completion date: June 16, 2021

Study information

• Verified date: July 2021
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Diagnostic Test:
• Treadmill test (Bruce protocol)
Treadmill test performed with and without a mask.

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Exercise Duration With vs Without a Mask		Through study completion, an average of 1 week
Other	Change in Heart Rate During Exercise With vs Without a Mask		Through study completion, an average of 1 week
Other	Change in Blood Pressure During Exercise With vs Without a Mask		Through study completion, an average of 1 week
Other	Change in Oxygen Saturation During Exercise With vs Without a Mask		Through study completion, an average of 1 week
Other	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
Other	Change in Calculated Maximal Oxygen Consumption During Exercise With vs Without a Mask		Through study completion, an average of 1 week
Primary	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	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