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

NCT04415879 | Completed

• 1 other identifier: 20-538
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

Exercise; Face Mask; COVID-19

Outcome Measures

Primary Outcomes (1)

• Exercise Capacity

  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).

  4 Weeks

Study Arms (3)

No Mask

ACTIVE COMPARATOR

Individuals will perform a Modified Balke Treadmill test with no mask and their estimated VO2 peak will be calculated based off of peak workload.

Other: N-95 Respirator; Other: Cloth Face Mask

N-95 Respirator

EXPERIMENTAL

Individuals will perform a Modified Balke Treadmill test while wearing a N-95 Respirator and their estimated VO2 peak will be calculated based off of peak workload.

Other: N-95 Respirator; Other: Cloth Face Mask

Cloth Mask

EXPERIMENTAL

Individuals will perform a Modified Balke Treadmill test while wearing a cloth mask and their estimated VO2 peak will be calculated based off of peak workload.

Other: N-95 Respirator; Other: Cloth Face Mask

Interventions

N-95 Respirator OTHER

N-95 mask will be worn as personal protective equipment during a graded exercise test

Cloth Mask; N-95 Respirator; No Mask

Cloth Face Mask OTHER

A cloth mask will be worn as personal protective equipment during a graded exercise test

Cloth Mask; N-95 Respirator; No Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Cleveland Clinic Employee
• Must not be pregnant

You may not qualify if:

• Medical condition that would interfere with ability to exercise safely

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

COVID-19; Motor Activity

Interventions

N95 Respirators

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)