NCT04819282

Brief Summary

In the COVID-19 pandemic, the use of masks in daily life has become an important issue. The most important measure taken to prevent contagion is the use of masks. The aim of the study is to determine the effects of surgical masks used in every moment of life on physical performance in elderly individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

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

September 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 24, 2021

Last Update Submit

March 26, 2021

Conditions

Keywords

Mask UsageGeriatricsExercise CapacityPhysical PerformanceSenior Fitness Test

Outcome Measures

Primary Outcomes (6)

  • Senior Fitness Test-Arm Curl

    Upper extremity strength

    Baseline

  • Senior Fitness Test-Chair Stand Up and Sitting

    Dynamic balance

    Baseline

  • Senior Fitness Test-Chair Sit and Reach

    Lower extremity flexibility

    Baseline

  • Senior Fitness Test-Back Scratch

    Upper extremity flexibility

    Baseline

  • Senior Fitness Test-Eight Foot Up and Go

    Dynamic agility

    Baseline

  • Senior Fitness Test-Two-Minute Step Test

    Aerobic endurance

    Baseline

Study Arms (1)

One group

Physical performance was evaluated with the Senior Fitness Test in one group of geriatric individuals.

Diagnostic Test: Senior Fitness Test

Interventions

Senior Fitness TestDIAGNOSTIC_TEST

Senior Fitness Test, simple and easy to use, was used to evaluate physical performance.

One group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals over the age of 65

You may qualify if:

  • geriatrics who had a score of ≥24 in the Mini Mental Test
  • which evaluates the cognitive levels of individuals over the age of 65
  • who were sufficient to perform physical function tests
  • who had not been diagnosed with COVID-19 before

You may not qualify if:

  • participants with severe respiratory disease (tuberculosis, severe COPD or bronchiectasis),
  • uncontrolled cardiac arrhythmia, unstable angina, heart failure, severe kidney disease, neurological disorders that could cause consciousness change
  • whose disease could not be controlled with medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, 42030, Turkey (Türkiye)

Location

Study Officials

  • Rıdvan Aktan

    Izmir University of Economics

    STUDY CHAIR
  • Özlem Akkoyun Sert

    KTO Karatay University

    STUDY CHAIR
  • Melike Akdam

    KTO Karatay University

    STUDY CHAIR
  • Buse Kılınç

    KTO Karatay University

    STUDY CHAIR
  • Sevgi Özalevli

    Dokuz Eylul University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

September 10, 2020

Primary Completion

December 30, 2020

Study Completion

February 17, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations