NCT04891120

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

May 5, 2021

Last Update Submit

July 26, 2021

Conditions

Healthy

Keywords

TreadmillBruceCOVID-19MaskHealthyAdultsMETSMetabolic equivalentBorgExerciseStress test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Other Outcomes (6)

  • 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

  • +3 more other outcomes

Study Arms (2)

With, then without a mask

EXPERIMENTAL

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)

Without, then with a mask

EXPERIMENTAL

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)

Interventions

Treadmill test (Bruce protocol)DIAGNOSTIC_TEST

Treadmill test performed with and without a mask.

With, then without a maskWithout, then with a mask

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18-65 years old)
  • Healthy
  • Vaccinated against COVID-19

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

BrucellosisCOVID-19Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Warner Mampuya, MD, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The statistician will be masked.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 18, 2021

Study Start

May 11, 2021

Primary Completion

June 16, 2021

Study Completion

June 16, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

All IPD that underlies results in a publication will be available in the supplementary appendix of the publication or on request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will be available at the time of the publication and for the 2 following years.

Locations

CA(1)