Face Masks and Oxygen Levels - What Happens During Exercise? (Masks in Exercise - a RandomIsed Trial) (MERIT)

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ClinicalTrials.gov Identifier: NCT04932226

Recruitment Status : Completed

First Posted : June 21, 2021

Last Update Posted : June 29, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

University of Nottingham

King's College London

Information provided by (Responsible Party):

University of Oxford

Study Description

Brief Summary:

The investigators 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.

Condition or disease	Intervention/treatment	Phase
Impact of Masks on Oxygen Levels	Device: cloth mask Device: surgical mask Device: FFP2 respirator	Not Applicable

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Detailed Description:

The investigators will conduct a crossover study comparing three different types of face mask (cloth, surgical or filtering facepiece respirator - 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. The investigators will promote the study through sports societies at three leading United Kingdom (UK) universities, namely the University of Oxford, University of Nottingham and King's College London. The investigators 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:

Running
Cycling
Rowing on a fixed machine

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:

a cloth mask
a surgical mask
a FFR
no mask

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 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
Actual Study Start Date :	June 19, 2021
Actual Primary Completion Date :	January 10, 2022
Actual Study Completion Date :	January 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Oxygen saturation [ Time Frame: Immediately after exercise ]
Oxygen saturation using pulse oximeter

Secondary Outcome Measures :

heart rate [ Time Frame: immediately after exercise ]
Heart rate
distance traveled [ Time Frame: immediately after exercise ]
distance traveled as a % of distance traveled when unmasked
comfort [ Time Frame: immediately after exercise ]
symptom survey of mask comfort and any adverse effects

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or Female, aged 18 - 35 years old.
Exercise at least three times a week on a regular basis.
Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

Known to have a significant acute or longstanding medical illness that limits their exercise capacity.
Develop symptoms of anosmia, cough or fever between agreeing to participate and completing the exercise, suggesting they may have developed COVID-19.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04932226

Locations

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United Kingdom
Trisha Greenhalgh
Oxford, Oxfordshire, United Kingdom, OX2 6GG

Sponsors and Collaborators

University of Oxford

University of Nottingham

King's College London

More Information

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Responsible Party:	University of Oxford
ClinicalTrials.gov Identifier:	NCT04932226
Other Study ID Numbers:	PHC_facemasks&exercise1
First Posted:	June 21, 2021 Key Record Dates
Last Update Posted:	June 29, 2022
Last Verified:	June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Will be placed on a website
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Time Frame:	12 months
Access Criteria:	Contact lead author

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

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