COVID-19NCT05401331
Effect of Mask Use on Hemodynamic Responses During Exertion
A study testing Treadmilll and mask in people with COVID-19 and Heart Rate, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The use of masks is a necessity due to the current pandemic conditions. The aim of the study is to examine the effects of the use of masks during effort on dyspnea and fatigue with hemodynamic parameters. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Heart Rate, Blood Pressure
- What is being tested?
- Treadmilll and mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 10 Jun 2022
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to work,
- To be healthy,
- 18-25 age range.
Who cannot join
- Unstabil angina pectoris,
- Atrial arrhythmia,
- Uncontrollable asthma,
- Pa02 < 50 mmHg,
- PaCO2> 70mmHg,
- Individuals with valve disease
Show all 10Show fewer
- Tachycardia, bradycardia,
- Individuals with a resting systolic blood pressure of 200 mmHg
- Smoking,
- Presence of effective clinical conditions such as nasal deviation.
Trial locations and contacts
1 site in 1 country.
About this study
The use of masks is a necessity due to the current pandemic conditions. The aim of the study is to examine the effects of the use of masks during effort on dyspnea and fatigue with hemodynamic parameters.
Read the detailed description
The use of masks is a necessity due to the current pandemic conditions.There are studies on many parameters such as the effect of mask use on saturation (sp02), heart rate (HR) and blood pressure (BP). To determine whether there is a change in the performance of individuals in the masked and unmasked exercise test during exertion due to the scarcity of masked and unmasked maximal exercise tests and the insufficient measurement of the degree of fatigue felt, and to determine whether there is a change in the performance of individuals with and without mask, and to determine the hemodynamic responses in the body together with dyspnea and felt fatigue. This study will be conducted in order to examine the effect on
- Conditions
- COVID-19, Heart Rate, Blood Pressure, Exercise Test, Mask
- Being tested
- Treadmilll, mask
- Keywords
- Dyspnea, Mask, Oxygen Saturation, Blood Pressure, Heart Rate, Exercise Test, COVİD-19
- Medical subject headings
- COVID-19, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadmilllDevice
Also called Saturation device, Sphygmomanometer
Hemodynamic changes before and after treadmill use
maskOther
mask
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic changes due to mask use | Other | Hemodynamic changes due to mask use Receives: Device: Treadmilll; Other: mask |
| Hemodynamic responses when we do not use masks | Other | Hemodynamic responses when we do not use masks Receives: Device: Treadmilll |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood pressure changes due to mask use
Blood pressure reading with sphygmomanometer.
Measured: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Evaluation of dyspnea score
Dyspnea score was evaluated with the Modified Borg Scale. The Modified Borg Scale is a 0 to 10 numerical score used to measure dyspnea. 0 indicates minimum dyspnea and 10 indicates maximum dyspnea.
Measured: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Evaluation of the degree of perceived fatigue
The degree of perceived fatigue was evaluated with the Modified Borg Scale. The Modified Borg Scale was used to assess perceived difficulty. The Modified Borg Scale is a numerical score from 0 to 10. 0 means minimum difficulty and 10 means maximum difficulty.
Measured: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Measurement of oxygen saturation and heart rate changes due to mask use
Oxygen saturation and heart rate were recorded with a pulseoximetry device.
Measured: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Apr 2022
- Primary completion1 May 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gülşah Karabıyık, Principal investigator, Saglik Bilimleri UniversitesiAyşegül Tunç, Principal investigator, Saglik Bilimleri UniversitesiZeynep Tanrıverdi, Principal investigator, Saglik Bilimleri UniversitesiSelen Öztürk, Principal investigator, Saglik Bilimleri UniversitesiFulya Senem Karaahmetoğlu, Principal investigator, Saglik Bilimleri UniversitesiHalit Çınarka, Principal investigator, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401331
- Sponsor's protocol ID
- Mask and Hemodynamic Responses
- Status last verified
- Feb 2022
- First submitted
- 11 Apr 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mask Use on Hemodynamic Responses During Exertion
- ClinicalTrials.gov ID
- NCT05401331
- Acronym / sponsor ID
- Mask and Hemodynamic Responses
- Conditions
- COVID-19, Heart Rate, Blood Pressure, Exercise Test, Mask
- Keywords
- Dyspnea, Mask, Oxygen Saturation, Blood Pressure, Heart Rate, Exercise Test, COVİD-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 2 Jun 2022 (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 use of masks is a necessity due to the current pandemic conditions. The aim of the study is to examine the effects of the use of masks during effort on dyspnea and fatigue with hemodynamic parameters.
Detailed description
The use of masks is a necessity due to the current pandemic conditions.There are studies on many parameters such as the effect of mask use on saturation (sp02), heart rate (HR) and blood pressure (BP). To determine whether there is a change in the performance of individuals in the masked and unmasked exercise test during exertion due to the scarcity of masked and unmasked maximal exercise tests and the insufficient measurement of the degree of fatigue felt, and to determine whether there is a change in the performance of individuals with and without mask, and to determine the hemodynamic responses in the body together with dyspnea and felt fatigue. This study will be conducted in order to examine the effect on
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic changes due to mask use | Other | Device: Treadmilll, Other: maskHemodynamic changes due to mask use |
| Hemodynamic responses when we do not use masks | Other | Device: TreadmilllHemodynamic responses when we do not use masks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteering to work,
- To be healthy,
- 18-25 age range.
Key exclusion criteria (10 listed)
- Unstabil angina pectoris,
- Atrial arrhythmia,
- Uncontrollable asthma,
- Pa02 < 50 mmHg,
- PaCO2> 70mmHg,
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 |
|---|---|---|
| TreadmilllAlso: Saturation device, SphygmomanometerHemodynamic changes before and after treadmill use | Device | Hemodynamic changes due to mask use, Hemodynamic responses when we do not use masks |
| maskmask | Other | Hemodynamic changes due to mask use |
Primary outcome
Measurement of blood pressure changes due to mask use
Time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Blood pressure reading with sphygmomanometer.
Evaluation of dyspnea score
Time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Dyspnea score was evaluated with the Modified Borg Scale. The Modified Borg Scale is a 0 to 10 numerical score used to measure dyspnea. 0 indicates minimum dyspnea and 10 indicates maximum dyspnea.
Evaluation of the degree of perceived fatigue
Time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
The degree of perceived fatigue was evaluated with the Modified Borg Scale. The Modified Borg Scale was used to assess perceived difficulty. The Modified Borg Scale is a numerical score from 0 to 10. 0 means minimum difficulty and 10 means maximum difficulty.
Measurement of oxygen saturation and heart rate changes due to mask use
Time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.
Oxygen saturation and heart rate were recorded with a pulseoximetry device.
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 30 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Gülşah Karabıyık principal investigator
Saglik Bilimleri Universitesi
Ayşegül Tunç principal investigator
Saglik Bilimleri Universitesi
Zeynep Tanrıverdi principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmilll and mask in people with COVID-19 and Heart Rate, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 10 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 30 Aug 2022. 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 Turkey (Türkiye). 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?
Measurement of blood pressure changes due to mask use (time frame: The period in which each participant is evaluated by taking the outcome criterion is 30-60 minutes.). The study lists 4 primary outcomes in all. 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 30 Aug 2022.