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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04932226
Recruitment Status : Completed
First Posted : June 21, 2021
Last Update Posted : June 29, 2022
Sponsor:
Collaborators:
University of Nottingham
King's College London
Information provided by (Responsible Party):
University of Oxford

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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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

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




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



Information from the National Library of Medicine

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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.

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
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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