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出境医 / 临床实验 / Face Masks and Oxygen Levels - What Happens During Exercise? (Masks in Exercise - a RandomIsed Trial) (MERIT)

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

Study Description
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.

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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Study Design
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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
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 :
  1. Oxygen saturation [ Time Frame: Immediately after exercise ]
    Oxygen saturation using pulse oximeter


Secondary Outcome Measures :
  1. heart rate [ Time Frame: immediately after exercise ]
    Heart rate

  2. distance traveled [ Time Frame: immediately after exercise ]
    distance traveled as a % of distance traveled when unmasked

  3. comfort [ Time Frame: immediately after exercise ]
    symptom survey of mask comfort and any adverse effects


Eligibility Criteria
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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

Locations
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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         
Sponsors and Collaborators
University of Oxford
University of Nottingham
King's College London
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
 (submitted: June 17, 2021)
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
 (submitted: June 17, 2021)
  • 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
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:

  • 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 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
  • 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
Study Arms  ICMJE All participants
Each participant is his/her own control. Each will have all four interventions in random order.
Interventions:
  • Device: cloth mask
  • Device: surgical mask
  • Device: FFP2 respirator
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
 (submitted: June 17, 2021)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Will be placed on a website
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 12 months
Access Criteria: Contact lead author
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE
  • University of Nottingham
  • King's College London
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