Treadmill Stress Test With and Without Mask

NCT ID: NCT04891120

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-11

Study Completion Date

2021-06-16

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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

The statistician will be masked.

Study Groups

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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.

Group Type EXPERIMENTAL

Treadmill test (Bruce protocol)

Intervention Type DIAGNOSTIC_TEST

Treadmill test performed with and without a mask.

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.

Group Type EXPERIMENTAL

Treadmill test (Bruce protocol)

Intervention Type DIAGNOSTIC_TEST

Treadmill test performed with and without a mask.

Interventions

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Treadmill test (Bruce protocol)

Treadmill test performed with and without a mask.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Warner Mampuya, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2021-4210

Identifier Type: -

Identifier Source: org_study_id

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