Exercise CapacityNCT04819282
Mask Usage and Physical Performance During COVID-19 Pandemic in Geriatrics
An observational study of Exercise Capacity and Geriatric, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Capacity, Geriatric, Mask
- What is being tested?
- Senior Fitness Test
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2020to 17 Feb 2021
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy individuals over the age of 65
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise Capacity, Geriatric, Mask
- Being tested
- Senior Fitness Test
- Keywords
- Mask Usage, Geriatrics, Exercise Capacity, Physical Performance, Senior Fitness Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senior Fitness TestDiagnostic test
Senior Fitness Test, simple and easy to use, was used to evaluate physical performance.
| Study group | Role | What they receive |
|---|---|---|
| One group | Physical performance was evaluated with the Senior Fitness Test in one group of geriatric individuals. Receives: Diagnostic Test: Senior Fitness Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Senior Fitness Test-Arm Curl
Upper extremity strength
Measured: Baseline
Senior Fitness Test-Chair Stand Up and Sitting
Dynamic balance
Measured: Baseline
Senior Fitness Test-Chair Sit and Reach
Lower extremity flexibility
Measured: Baseline
Senior Fitness Test-Back Scratch
Upper extremity flexibility
Measured: Baseline
Senior Fitness Test-Eight Foot Up and Go
Dynamic agility
Measured: Baseline
Senior Fitness Test-Two-Minute Step Test
Aerobic endurance
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start10 Sep 2020
- Primary completion30 Dec 2020
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise CapacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Alkan, KTO Karatay University
- Investigators
- Rıdvan Aktan, Study chair, Izmir University of EconomicsÖzlem Akkoyun Sert, Study chair, KTO Karatay UniversityMelike Akdam, Study chair, KTO Karatay UniversityBuse Kılınç, Study chair, KTO Karatay UniversitySevgi Özalevli, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819282
- Sponsor's protocol ID
- KaratayU4
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Surgical Masks in the COVID-19 Pandemic: Does it Affect Physical Performance in Geriatrics?
- ClinicalTrials.gov ID
- NCT04819282
- Acronym / sponsor ID
- KaratayU4
- Conditions
- Exercise Capacity, Geriatric, Mask
- Keywords
- Mask Usage, Geriatrics, Exercise Capacity, Physical Performance, Senior Fitness Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | – | Diagnostic Test: Senior Fitness TestPhysical performance was evaluated with the Senior Fitness Test in one group of geriatric individuals. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy individuals over the age of 65
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senior Fitness TestSenior Fitness Test, simple and easy to use, was used to evaluate physical performance. | Diagnostic test | One group |
Primary outcome
Senior Fitness Test-Arm Curl
Time frame: Baseline
Upper extremity strength
Senior Fitness Test-Chair Stand Up and Sitting
Time frame: Baseline
Dynamic balance
Senior Fitness Test-Chair Sit and Reach
Time frame: Baseline
Lower extremity flexibility
Senior Fitness Test-Back Scratch
Time frame: Baseline
Upper extremity flexibility
Senior Fitness Test-Eight Foot Up and Go
Time frame: Baseline
Dynamic agility
Senior Fitness Test-Two-Minute Step Test
Time frame: Baseline
Aerobic endurance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rıdvan Aktan study chair
Izmir University of Economics
Özlem Akkoyun Sert study chair
KTO Karatay University
Melike Akdam study chair
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Capacity and Geriatric, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Senior Fitness Test-Arm Curl (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.