- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819282
Mask Usage and Physical Performance During COVID-19 Pandemic in Geriatrics
March 26, 2021 updated by: Büşra Alkan, KTO Karatay University
Use of Surgical Masks in the COVID-19 Pandemic: Does it Affect Physical Performance in Geriatrics?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Physical performance measurements were carried out by a physiotherapist using the Senior Fitness Test (SFT).
Participants were informed about the procedure of the test.
All participants performed two evaluation sessions by the SFT with and without using a surgical mask.
The participants were randomly selected to perform the test whether with or without the surgical mask at first.
The sessions were held at least 24 hours apart to prevent fatigue.
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karatay
-
Konya, Karatay, Turkey, 42030
- KTO Karatay University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy individuals over the age of 65
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
One group
Physical performance was evaluated with the Senior Fitness Test in one group of geriatric individuals.
|
Senior Fitness Test, simple and easy to use, was used to evaluate physical performance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Senior Fitness Test-Arm Curl
Time Frame: Baseline
|
Upper extremity strength
|
Baseline
|
|
Senior Fitness Test-Chair Stand Up and Sitting
Time Frame: Baseline
|
Dynamic balance
|
Baseline
|
|
Senior Fitness Test-Chair Sit and Reach
Time Frame: Baseline
|
Lower extremity flexibility
|
Baseline
|
|
Senior Fitness Test-Back Scratch
Time Frame: Baseline
|
Upper extremity flexibility
|
Baseline
|
|
Senior Fitness Test-Eight Foot Up and Go
Time Frame: Baseline
|
Dynamic agility
|
Baseline
|
|
Senior Fitness Test-Two-Minute Step Test
Time Frame: Baseline
|
Aerobic endurance
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2020
Primary Completion (Actual)
December 30, 2020
Study Completion (Actual)
February 17, 2021
Study Registration Dates
First Submitted
March 24, 2021
First Submitted That Met QC Criteria
March 24, 2021
First Posted (Actual)
March 26, 2021
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 26, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaratayU4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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