HealthyTREADMASKNCT04891120
Treadmill Stress Test With and Without Mask
A study testing Treadmill test (Bruce protocol) in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The purpose of this study is to assess if wearing a surgical mask affects the results of a standard treadmill test. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treadmill test (Bruce protocol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 11 May 2021to 16 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18-65 years old)
- Healthy
- Vaccinated against COVID-19
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Treadmill test (Bruce protocol)
- Keywords
- Treadmill, Bruce, COVID-19, Mask, Healthy, Adults, METS, Metabolic equivalent, Borg, Exercise, Stress test
- Medical subject headings
- Brucellosis, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill test (Bruce protocol)Diagnostic test
Treadmill test performed with and without a mask.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Treadmill test (Bruce protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Metabolic Equivalents With vs Without a Mask
The maximal metabolic equivalents achieved will be calculated for each treadmill test performed.
Measured: 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
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.
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start11 May 2021
- Primary completion16 Jun 2021
- Study completion16 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warner Mampuya, MD, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891120
- Sponsor's protocol ID
- 2021-4210
- Acronym
- TREADMASK
- Status last verified
- Jul 2021
- First submitted
- 5 May 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlies results in a publication will be available in the supplementary appendix of the publication or on request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill Stress Test With and Without Mask: Comparison of Exercise Capacity and Perception
- ClinicalTrials.gov ID
- NCT04891120
- Acronym / sponsor ID
- TREADMASK / 2021-4210
- Conditions
- Healthy
- Keywords
- Treadmill, Bruce, COVID-19, Mask, Healthy, Adults, METS, Metabolic equivalent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if wearing a surgical mask affects the results of a standard treadmill test.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With, then without a mask | Experimental | Diagnostic Test: Treadmill test (Bruce protocol)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. |
| Without, then with a mask | Experimental | Diagnostic Test: Treadmill test (Bruce protocol)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18-65 years old)
- Healthy
- Vaccinated against COVID-19
Key exclusion criteria (7 listed)
- Any cardiac or respiratory condition
- Walking difficulty
- Waiting for a stress test for a medical reason
- Abnormal resting ECG
- Inability to wear a mask
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill test (Bruce protocol)Treadmill test performed with and without a mask. | Diagnostic test | With, then without a mask, Without, then with a mask |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: Yes. All IPD that underlies results in a publication will be available in the supplementary appendix of the publication or on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warner Mampuya, MD, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill test (Bruce protocol) in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Metabolic Equivalents With vs Without a Mask (time frame: Through study completion, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.