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NCT04415879 · ClinicalTrials.gov registry record · NA

Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.

A NA study, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT04415879: Completed NA study, sponsored by The Cleveland Clinic.

NCT04415879 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04415879, a NA study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

This study intends to find out how a cloth mask may impact exercise capacity, to provide guidance for exercisers to adjust their expectations and training accordingly. The investigators plan to asses exercise capacity through estimated peak oxygen consumption (eVO2peak), oxygen saturation and level of perceived exertion during treadmill based exercise while wearing a cloth mask compared to exercising without a cloth mask. The potential significance of this study is to determine if subjects can exercise safely and if their exercise training needs to be adjusted while following the current recommendations of wearing a cloth mask in public. The degree of airflow limitation experienced will depend on the type and fit of the mask being worn, and inadequeate airflow could possibly result in CO2 re-breathing if all air was not fully discharged from the mask with each breath. This re-breathing of CO2 could potentially limit the workload leading to a detriment in performance, and increase in adverse symptoms such as dizziness, lightheadedness, chest pain or shortness of breath that does not improve with rest.

Primary Outcome

To gain further understanding on effects exercising with a cloth mask has on exercise capacity. Our working hypothesis is that wearing a face mask will limit exercise capacity by a minimal clinically important difference (MCID) of 1 estimated Metabolic Equivalent (eMET 3.5 O2 ml/kg/min).

Interventions

  • OTHER N-95 Respirator
  • OTHER Cloth Face Mask

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-06-01
Est. Completion 2020-08-01
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT04415879 record still lists

NCT04415879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which N-95 Respirator is the first listed.

NCT04415879 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04415879 about?

NCT04415879 is a clinical study titled "Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.". This study intends to find out how a cloth mask may impact exercise capacity, to provide guidance for exercisers to adjust their expectations and training accordingly. The investigators plan to asses exercise capacity through estimated peak oxygen consumption (eVO2peak), oxygen saturation and level ...

What is the current status of trial NCT04415879?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2020-06-01. Estimated completion is 2020-08-01.

What interventions are being tested in trial NCT04415879?

The interventions under investigation include: N-95 Respirator (OTHER), Cloth Face Mask (OTHER).

Who is sponsoring clinical trial NCT04415879?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04415879's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04415879, the US trial registry maintained by the National Library of Medicine. NCT04415879 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.