Face Masks and Oxygen Levels - What Happens During Exercise? (Masks in Exercise - a RandomIsed Trial)
Condition: Impact of Masks on Oxygen Levels
Study type: Interventional

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.
    

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-rando
      misation-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.
    

Intervention name(s): cloth mask; surgical mask; FFP2 respirator
Intervention type(s): Device; Device; Device
Intervention description(s): Buff bandana double layer worn over nose and mouth; standard surgical mask; filtering facepiece 2 respirator
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