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Completed

NCT Number: NCT04891120

Treadmill Stress Test With and Without Mask

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

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Key information

Conditions

Healthy Bacterial Infections Bacterial Infections and Mycoses Behavior Brucellosis COVID-19 Coronaviridae Infections Coronavirus Infections Gram-Negative Bacterial Infections Infections Lung Diseases Motor Activity Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill test (Bruce protocol)

Diagnostic Test

Treadmill test performed with and without a mask.

Primary outcomes

  1. Change in Metabolic Equivalents With vs Without a Mask

    Time frame: Through study completion, an average of 1 week

    The maximal metabolic equivalents achieved will be calculated for each treadmill test performed.

Secondary outcomes

  1. Change in Borg's Category-Ratio Scale for Rating of Perceived Exertion With vs Without a Mask

    Time frame: 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 outcomes

  1. Change in Exercise Duration With vs Without a Mask

    Time frame: Through study completion, an average of 1 week

  2. Change in Heart Rate During Exercise With vs Without a Mask

    Time frame: Through study completion, an average of 1 week

  3. Change in Blood Pressure During Exercise With vs Without a Mask

    Time frame: Through study completion, an average of 1 week

  4. Change in Oxygen Saturation During Exercise With vs Without a Mask

    Time frame: Through study completion, an average of 1 week

  5. Change in Duration of Exercise Before Reaching 85% of Predicted Maximal Heart Rate With vs Without a Mask

    Time frame: Through study completion, an average of 1 week

  6. Change in Calculated Maximal Oxygen Consumption During Exercise With vs Without a Mask

    Time frame: Through study completion, an average of 1 week

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Acronym: TREADMASK

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 18, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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