Condition or disease | Intervention/treatment | Phase |
---|---|---|
Impact of Masks on Oxygen Levels | Device: cloth mask Device: surgical mask Device: FFP2 respirator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Each participant is own control. Each participant will undergo all four interventions in random order. |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Peripheral Oxygen Saturations Among Healthy Young Adults Wearing Face Masks Whilst Exercising |
Estimated Study Start Date : | June 20, 2021 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
---|---|
All participants
Each participant is his/her own control. Each will have all four interventions in random order.
|
Device: cloth mask
Buff bandana double layer worn over nose and mouth
Device: surgical mask standard surgical mask
Device: FFP2 respirator filtering facepiece 2 respirator
|
Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Trisha Greenhalgh | Recruiting |
Oxford, Oxfordshire, United Kingdom, OX2 6GG | |
Contact: Trisha Greenhalgh, PhD 07769177924 trish.greenhalgh@phc.ox.ac.uk | |
Sub-Investigator: Nicholas Jones, BM BCh | |
Sub-Investigator: Dylan McGagh |
Tracking Information | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | June 17, 2021 | ||||||||||||||||
First Posted Date ICMJE | June 21, 2021 | ||||||||||||||||
Last Update Posted Date | June 21, 2021 | ||||||||||||||||
Estimated Study Start Date ICMJE | June 20, 2021 | ||||||||||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Oxygen saturation [ Time Frame: Immediately after exercise ] Oxygen saturation using pulse oximeter
|
||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | No Changes Posted | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Face Masks and Oxygen Levels - What Happens During Exercise? (Masks in Exercise - a RandomIsed Trial) | ||||||||||||||||
Official Title ICMJE | Peripheral Oxygen Saturations Among Healthy Young Adults Wearing Face Masks Whilst Exercising | ||||||||||||||||
Brief Summary | We aim to determine the effect of three different types of face mask compared to no face mask on the oxygen saturations, heart rate and symptoms of healthy young adults during 15 minutes of moderate to high intensity exercise. The three face masks will be a cloth mask, a surgical mask and a FFR. | ||||||||||||||||
Detailed Description |
We will conduct a crossover study comparing three different types of face mask (cloth, surgical or FFR) versus no face mask to determine the effect on oxygen saturations, heart rate and symptoms of healthy young adults during 15 minutes of moderate to high intensity exercise. We will promote the study through sports societies at three leading UK universities, namely the University of Oxford, University of Nottingham and King's College London. We will also advertise the study on social media. Interested individuals will be encouraged to visit the study website or read the patient information sheets available to share via email. Volunteer participants will be asked to read the eligibility criteria, patient information sheet and recruitment information before applying to take part. Those who wish to participate will be asked to complete an online form, including their first name, date of birth, address, email address, demographics, details of their regular exercise and details of any past medical history or medication. Those wishing to discuss the study will have the opportunity to request a phone call from a member of the study team before agreeing to take part. Submitted applications will be screened by the study team for eligibility. Those who are deemed not to be eligible will be contacted, explaining the reason. Selected participants will be informed and contacted to arrange a date for the study session. This will be conducted at their local university sports centre or a local park. The number of participants attending a single study session will be in compliance with any UK government restrictions relating to COVID-19 in place at that time. On the day of the study, participants will meet a member of the study team, who will ask them to complete an online consent form. Participants will then be asked to complete an exercise study session. The type of exercise will be either:
Participants will be asked to complete four x 15 minute pieces of exercise within this single session. The aim will be to exercise at moderate to high intensity with the goal of covering the same distance each time. Between 15 minutes of exercise, participants will be asked to take a 5 minute rest break. For each 15 minute session, participants will wear one of the following:
The order in which participants wear the face masks will be determined by a random sequence generator(https://www.phc.ox.ac.uk/research/technology-outputs/sortition-clinical-trial-randomisation-software). The masks will be provided by the researcher at the time. Participants will wear no mask during each rest period. Prior to starting, participants will have their resting heart rate and oxygen levels recorded. Halfway through each exercise period, immediately on completing the exercise and at 1 minute following completion of the exercise, participants will have their heart rate, oxygen levels and distance travelled recorded by a member of the study team. Upon completion of the exercise session, participants will be asked to complete an online survey via a secure portal, hosted by the University of Oxford. They will be asked to complete questions regarding the type of exercise they did, oxygen levels and heart rate at each time point, distance travelled and average speed, and questions regarding the ease of exercise and comfort of wearing each masks, as well as any additional symptoms they might have experienced during the exercise session as a result of wearing the mask. |
||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Each participant is own control. Each participant will undergo all four interventions in random order. Masking: None (Open Label)Primary Purpose: Health Services Research |
||||||||||||||||
Condition ICMJE | Impact of Masks on Oxygen Levels | ||||||||||||||||
Intervention ICMJE |
|
||||||||||||||||
Study Arms ICMJE | All participants
Each participant is his/her own control. Each will have all four interventions in random order.
Interventions:
|
||||||||||||||||
Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||
Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
60 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
Sex/Gender ICMJE |
|
||||||||||||||||
Ages ICMJE | 18 Years to 35 Years (Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||
Contacts ICMJE | |||||||||||||||||
Listed Location Countries ICMJE | United Kingdom | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04932226 | ||||||||||||||||
Other Study ID Numbers ICMJE | PHC_facemasks&exercise1 | ||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
|
||||||||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||||||||
Responsible Party | University of Oxford | ||||||||||||||||
Study Sponsor ICMJE | University of Oxford | ||||||||||||||||
Collaborators ICMJE |
|
||||||||||||||||
Investigators ICMJE | Not Provided | ||||||||||||||||
PRS Account | University of Oxford | ||||||||||||||||
Verification Date | June 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |