NCT04785781

Brief Summary

The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. The results of our study will show the effects of face masks commonly used during the pandemic period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

February 24, 2021

Last Update Submit

March 22, 2022

Conditions

Covid-19

Keywords

covid19cardiopulmoaryexercise capacityface masks

Outcome Measures

Primary Outcomes (2)

  • time to exhaustion

    individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion

    5-10 minutes

  • Mask comfort/discomfort

    Mask comfort/discomfort will be assesed by published questionnaire quantify the following ten domains of comfort/discomfort of wearing a mask: humidity, heat, breathing resistance, itchiness, tightness, saltiness, feeling unfit, odor, fatigue, and overall discomfort

    5-10 minutes

Secondary Outcomes (3)

  • heart rate

    1 minute

  • oxygen saturation

    1 minute

  • respiratory frequency

    1 minute

Study Arms (3)

no mask

OTHER

individuals perform cardiopulmonary test via cycle ergometer without mask till voluntary exhaustion

Other: without masks

surgical mask

OTHER

individuals perform cardiopulmonary test via cycle ergometer with surgical mask till voluntary exhaustion

Other: Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)

N95/fpp2

OTHER

individuals perform cardiopulmonary test via cycle ergometer with N95 mask till voluntary exhaustion

Other: FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)

Interventions

without masksOTHER

apply a bicycle ergometer test protocol to individuals without a mask

no mask
Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)OTHER

apply a bicycle ergometer test protocol to individuals with a surgical mask

surgical mask
FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)OTHER

apply a bicycle ergometer test protocol to individuals with a FFP2\\N95 mask

N95/fpp2

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old to 30
  • healthy young individuals

You may not qualify if:

  • having cardiovasculary conditions
  • having respiratory conditions
  • having inflammatory conditions
  • any contraindicated situations for cardiopulmonary tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

MasksLong-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and AgricultureNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fatma Ünver

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: individuals will perform cycle ergometer without mask, with surgical mask and FFP2/N95. there will be 48 hours wash-out between tests.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc, Research Assitant

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 8, 2021

Study Start

February 1, 2021

Primary Completion

April 14, 2021

Study Completion

April 15, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)