COVID-19 PandemicNCT05905211
Investigation of Physical and Emotional Status the Elderly Infected and Non-Infected With COVID-19
An observational study of COVID-19 Pandemic, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to evaluate individuals in terms of balance, functional mobility, influences in activities of daily living, fear of COVID-19, moods, quality of life parameters in order to investigate the effects of COVID-19 on elderly individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Observational Tests
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2022to 25 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Including 52 elderly individuals who survived the COVID-19 and 55 elderly individuals who non-infected COVID-19. The group who had COVID-19 was treated in the pandemic ward of Tarsus State Hospital with a definitive diagnosis of COVID-19, and over whose condition was planned to be discharged were included in the study just before discharge. Elderly individuals aged 65 and over who did not have COVID-19 were reached in Tarsus city center by snowball sampling method.
Who may be able to join
- Being an individual aged 65 and over voluntarily to participate in the study
- Not having a problem affecting understanding and speaking, having the ability to walk without any help
Who cannot join
- Having any musculoskeletal or neurological problem that may affect walking and balance
- Have a known mental problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Balance, Functional Mobility, Quality of Life, Fear of COVID-19 and Emotional State of the Elderly Infected and Non-Infected With COVID-19
The aim of this observational study is to evaluate individuals in terms of balance, functional mobility, influences in activities of daily living, fear of COVID-19, moods, quality of life parameters in order to investigate the effects of COVID-19 on elderly individuals.
Read the detailed description
This study was carried out to investigate the status of elderly individuals who survived the COVID-19 in terms of different parameters such as balance, functional mobility, activities of daily living, quality of life, fear of COVID-19, depression. A total of 107 elderly individuals aged 65 and over were included in the study, including 52 elderly individuals who survived the COVID-19 and 55 elderly individuals who non-infected COVID-19. The sociodemographic information of the participants was recorded. The Berg Balance Scale was used to evaluate the balance levels, the Timed Up and Go Test was used to evaluate the functional mobility levels, and the Functional Independence Scale was used to evaluate the activities of daily living. The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD) was used to evaluate the quality of life, the Fear of COVID-19 Scale was used to evaluate the COVID-19 Fear levels, the Geriatric Depression Scale was used to evaluate the symptoms of depression.
- Conditions
- COVID-19 Pandemic
- Being tested
- Observational Tests
- Keywords
- Geriatrics, Aged, Functional Status, Postural Balance, Quality of Life, Activities of Daily Living, Fear, Depression, COVID-19
- Medical subject headings
- COVID-19, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational TestsOther
The Berg Balance Scale was used to evaluate the balance levels, the Timed Up and Go Test was used to evaluate the functional mobility levels, and the Functional Independence Scale was used to evaluate the activities of daily living. The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD) was used to evaluate the quality of life, the Fear of COVID-19 Scale was used to evaluate the COVID-19 fear levels, the Geriatric Depression Scale was used to evaluate the symptoms of depression.
| Study group | Role | What they receive |
|---|---|---|
| Infected COVID-19 | Balance, functional mobility, activities of daily living, quality of life, fear of COVID-19, depression evaluated Receives: Other: Observational Tests | |
| Non-Infected COVID-19 | Balance, functional mobility, activities of daily living, quality of life, fear of COVID-19, depression evaluated Receives: Other: Observational Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
It is a method that allows functional assessment of balance in individuals through activities of daily living. Its Turkish validity and reliability was conducted by Sahin et al. The scale consists of 14 items that the researcher fills in by observing the individual and each item is graded between 0 and 4 points. It includes daily functional activities such as standing up from a sitting position, standing and sitting without support, reaching forward while standing, picking up objects from the floor, turning 360°, standing on one leg. A ruler, stopwatch, chair, step, etc. are used during the test. The highest score that can be obtained from the test is 56 and the range of 0-20 points indicates a balance disorder leading to a high risk of falling, the range of 21-40 points indicates that the individual has an acceptable balance, and the range of 41-56 points indicates that the individual has good balance.
Measured: 2 months
Timed Up and Go Test
It is a reliable method widely used to assess functional mobility and balance in individuals. It is a test that the researcher applies by observing the individual. The test starts with the command "start" and ends with the participant getting up from the chair, walking 3 meters, turning around and then walking back to the chair and sitting down. The time from the "start" command to the end of the test is measured with a stopwatch.
Measured: 2 months
Functional Independence Scale
It shows the independence levels of individuals in basic physical and cognitive functions in activities of daily living. Turkish validity and reliability was conducted by Kücükdeveci et al. The scale is administered by the researcher's observation of the physical condition and question and answer method. It measures two sub-headings: physical/motor function and cognitive/cognitive function. In the scale consisting of 18 items in total, 13 questions evaluate motor functions and 5 questions evaluate cognitive functions. Self-care, sphincter control, transfer, mobility, communication, social perception are the functions questioned by the scale. Each item is scored between 1-7 points. 7 points indicates complete independence and 1 point indicates complete dependence. The participant can score between 18-126 points on the scale. A high total score indicates a high level of independence.
Measured: 2 months
The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)
It is a six-dimensional, 5-point Likert-type scale consisting of 24 questions and used to assess quality of life in the elderly. Its Turkish validity and reliability was performed by Eser et al. (2010) The scale is applied in the form of question and answer. The sub-dimensions of the scale are sensory functions, autonomy, past-present and future activities, social participation, dying and death, and closeness. Scoring for each question is done on a scale of 1-5. Possible dimension scores range from 4-20. In addition, a total score can be calculated by adding the scores together. A higher score indicates an improved quality of life.
Measured: 2 months
The Fear of COVID-19 Scale
It is a unidimensional scale and consists of a total of 7 items, each item is designed in 5-point Likert type. The scale was adapted into Turkish by Bakioglu et al. (2021). The scale is applied in question and answer form. The participant is asked to mark between '1 - Strongly Disagree' and '5 - Strongly Agree'. A score between 7-35 is obtained from the scale. An increase in the total score indicates that the participant's level of fear of COVID-19 has increased.
Measured: 2 months
Geriatric Depression Scale
It is a self-report scale consisting of a total of 30 questions that should be answered yes/no. Its Turkish validity and reliability was conducted by Ertan et al. (1997). The minimum score that can be obtained in the scale is 0 and the maximum score is 30, and each answer given for depression status is 1 point and the other answers are 0 points. A score range of 0-10 points indicates no depression, a score range of 11-13 points indicates possible depression, while scores of 14 points and above are considered as definite depression.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start11 Feb 2022
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Responsible party
- Principal investigator, Ali MUTLU, Tarsus University
- Investigators
- Ali MUTLU, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905211
- Sponsor's protocol ID
- TU-FTR-AMUTLU-1
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 15 Jun 2023
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Balance, Functional Mobility, Quality of Life, Fear of COVID-19 and Emotional State of the Elderly Infected and Non-Infected With COVID-19
- ClinicalTrials.gov ID
- NCT05905211
- Acronym / sponsor ID
- TU-FTR-AMUTLU-1
- Conditions
- COVID-19 Pandemic
- Keywords
- Geriatrics, Aged, Functional Status, Postural Balance, Quality of Life, Activities of Daily Living, Fear, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 15 Jun 2023 (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.
The aim of this observational study is to evaluate individuals in terms of balance, functional mobility, influences in activities of daily living, fear of COVID-19, moods, quality of life parameters in order to investigate the effects of COVID-19 on elderly individuals.
Detailed description
This study was carried out to investigate the status of elderly individuals who survived the COVID-19 in terms of different parameters such as balance, functional mobility, activities of daily living, quality of life, fear of COVID-19, depression. A total of 107 elderly individuals aged 65 and over were included in the study, including 52 elderly individuals who survived the COVID-19 and 55 elderly individuals who non-infected COVID-19. The sociodemographic information of the participants was recorded. The Berg Balance Scale was used to evaluate the balance levels, the Timed Up and Go Test was used to evaluate the functional mobility levels, and the Functional Independence Scale was used to evaluate the activities of daily living. The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD) was used to evaluate the quality of life, the Fear of COVID-19 Scale was used to evaluate the COVID-19 Fear levels, the Geriatric Depression Scale was used to evaluate the symptoms of depression.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infected COVID-19 | – | Other: Observational TestsBalance, functional mobility, activities of daily living, quality of life, fear of COVID-19, depression evaluated |
| Non-Infected COVID-19 | – | Other: Observational TestsBalance, functional mobility, activities of daily living, quality of life, fear of COVID-19, depression evaluated |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Including 52 elderly individuals who survived the COVID-19 and 55 elderly individuals who non-infected COVID-19. The group who had COVID-19 was treated in the pandemic ward of Tarsus State Hospital with a definitive diagnosis of COVID-19, and over whose condition was planned to be discharged were included in the study just before discharge. Elderly individuals aged 65 and over who did not have COVID-19 were reached in Tarsus city center by snowball sampling method.
Key inclusion criteria (2 listed)
- Being an individual aged 65 and over voluntarily to participate in the study
- Not having a problem affecting understanding and speaking, having the ability to walk without any help
Key exclusion criteria (2 listed)
- Having any musculoskeletal or neurological problem that may affect walking and balance
- Have a known mental problem
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 |
|---|---|---|
| Observational TestsThe Berg Balance Scale was used to evaluate the balance levels, the Timed Up and Go Test was used to evaluate the functional mobility levels, and the Functional Independence Scale was used to evaluate the activities of daily living. The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD) was used to evaluate the quality of life, the Fear of COVID-19 Scale was used to evaluate the COVID-19 fear levels, the Geriatric Depression Scale was used to evaluate the symptoms of depression. | Other | Infected COVID-19, Non-Infected COVID-19 |
Primary outcome
Berg Balance Scale
Time frame: 2 months
It is a method that allows functional assessment of balance in individuals through activities of daily living. Its Turkish validity and reliability was conducted by Sahin et al. The scale consists of 14 items that the researcher fills in by observing the individual and each item is graded between 0 and 4 points. It includes daily functional activities such as standing up from a sitting position, standing and sitting without support, reaching forward while standing, picking up objects from the floor, turning 360°, standing on one leg. A ruler, stopwatch, chair, step, etc. are used during the test. The highest score that can be obtained from the test is 56 and the range of 0-20 points indicates a balance disorder leading to a high risk of falling, the range of 21-40 points indicates that the individual has an acceptable balance, and the range of 41-56 points indicates that the individual has good balance.
Timed Up and Go Test
Time frame: 2 months
It is a reliable method widely used to assess functional mobility and balance in individuals. It is a test that the researcher applies by observing the individual. The test starts with the command "start" and ends with the participant getting up from the chair, walking 3 meters, turning around and then walking back to the chair and sitting down. The time from the "start" command to the end of the test is measured with a stopwatch.
Functional Independence Scale
Time frame: 2 months
It shows the independence levels of individuals in basic physical and cognitive functions in activities of daily living. Turkish validity and reliability was conducted by Kücükdeveci et al. The scale is administered by the researcher's observation of the physical condition and question and answer method. It measures two sub-headings: physical/motor function and cognitive/cognitive function. In the scale consisting of 18 items in total, 13 questions evaluate motor functions and 5 questions evaluate cognitive functions. Self-care, sphincter control, transfer, mobility, communication, social perception are the functions questioned by the scale. Each item is scored between 1-7 points. 7 points indicates complete independence and 1 point indicates complete dependence. The participant can score between 18-126 points on the scale. A high total score indicates a high level of independence.
The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)
Time frame: 2 months
It is a six-dimensional, 5-point Likert-type scale consisting of 24 questions and used to assess quality of life in the elderly. Its Turkish validity and reliability was performed by Eser et al. (2010) The scale is applied in the form of question and answer. The sub-dimensions of the scale are sensory functions, autonomy, past-present and future activities, social participation, dying and death, and closeness. Scoring for each question is done on a scale of 1-5. Possible dimension scores range from 4-20. In addition, a total score can be calculated by adding the scores together. A higher score indicates an improved quality of life.
The Fear of COVID-19 Scale
Time frame: 2 months
It is a unidimensional scale and consists of a total of 7 items, each item is designed in 5-point Likert type. The scale was adapted into Turkish by Bakioglu et al. (2021). The scale is applied in question and answer form. The participant is asked to mark between '1 - Strongly Disagree' and '5 - Strongly Agree'. A score between 7-35 is obtained from the scale. An increase in the total score indicates that the participant's level of fear of COVID-19 has increased.
Geriatric Depression Scale
Time frame: 2 months
It is a self-report scale consisting of a total of 30 questions that should be answered yes/no. Its Turkish validity and reliability was conducted by Ertan et al. (1997). The minimum score that can be obtained in the scale is 0 and the maximum score is 30, and each answer given for depression status is 1 point and the other answers are 0 points. A score range of 0-10 points indicates no depression, a score range of 11-13 points indicates possible depression, while scores of 14 points and above are considered as definite depression.
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 15 Jun 2023.
- 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.
Ali MUTLU principal investigator
Tarsus 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 COVID-19 Pandemic, run by Tarsus 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 2 inclusion and 2 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 15 Jun 2023. 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?
Berg Balance Scale (time frame: 2 months). 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 15 Jun 2023.