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

NCT04932226 | Completed

• 1 other identifier: PHC_facemasks&exercise1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Impact of Masks on Oxygen Levels

Outcome Measures

Primary Outcomes (1)

• Oxygen saturation

  Oxygen saturation using pulse oximeter

  Immediately after exercise

Secondary Outcomes (3)

• heart rate

  immediately after exercise

• distance traveled

  immediately after exercise

• comfort

  immediately after exercise

Study Arms (1)

All participants

OTHER

Each participant is his/her own control. Each will have all four interventions in random order.

Device: cloth mask; Device: surgical mask; Device: FFP2 respirator

Interventions

cloth mask DEVICE

Buff bandana double layer worn over nose and mouth

All participants

surgical mask DEVICE

standard surgical mask

All participants

FFP2 respirator DEVICE

filtering facepiece 2 respirator

All participants

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• University of Nottingham: collaborator
• King's College London: collaborator

Study Sites (1)

Trisha Greenhalgh

Oxford, Oxfordshire, OX2 6GG, United Kingdom

Location

Related Publications (1)

• Jones N, Oke J, Marsh S, Nikbin K, Bowley J, Dijkstra HP, Hobbs FR, Greenhalgh T. Face masks while exercising trial (MERIT): a cross-over randomised controlled study. BMJ Open. 2023 Jan 5;13(1):e063014. doi: 10.1136/bmjopen-2022-063014.

  PMID: 36604128 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant is own control. Each participant will undergo all four interventions in random order.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 21, 2021
• Study Start: June 19, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: June 29, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months
• Access Criteria: Contact lead author

Locations

GB (1)