GeriatricsNCT05398523
Activities of Daily Living in Older Adults
An observational study of Geriatrics, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
In order to maintain independence and prevent disability, it is essential to identify associated factors and reduce functional loss due to concomitant diseases. This study aimed to examine the effects of frailty, balance, and depression on the performance of activities of daily living in older adults. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Geriatrics
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jul 2020to 10 Jan 2021
- How long will I take part?
- 1 Day
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: adults aged 65 years or older who were registered at Community Health Center No.1 in City Central Amasya.
Who may be able to join
- aged 65 years or older
- being able to understand and answer the questionnaires used for data collection
- having mental competency as demonstrated by a score higher than 20 on the Mini Mental State Test
Who cannot join
- limited ambulation
- psychological problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Frailty, Balance, and Depression With Activities of Daily Living in Older Adults
In order to maintain independence and prevent disability, it is essential to identify associated factors and reduce functional loss due to concomitant diseases. This study aimed to examine the effects of frailty, balance, and depression on the performance of activities of daily living in older adults. All participants were assessed using the Mini Mental State Test, simple FRAIL scale, Geriatric Depression Scale-Short Form, and Lawton Instrumental Activities of Daily Living Scale (IADL).
Read the detailed description
As the global population becomes older, the importance of preserving health, function, and quality of life is being increasingly recognized. In order to maintain independence and prevent disability, it is essential to identify associated factors and reduce functional loss due to concomitant diseases. This study aimed to examine the effects of frailty, balance, and depression on the performance of activities of daily living in older adults. All participants were assessed using the Mini Mental State Test, simple FRAIL scale, Geriatric Depression Scale-Short Form, and Lawton Instrumental Activities of Daily Living Scale (IADL).
- Conditions
- Geriatrics
- Keywords
- Frailty, balance, depression, activities of daily living
- Medical subject headings
- Frailty, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Test
Cognitive function was assessed using the MMST, which consists of 11 items. The MMST has a maximum score of 30 points; scores above 24 points are considered sufficient and scores lower than 20 indicate cognitive impairment
Measured: at the enrollment
Secondary outcomes (4)
FRAIL scale
This 5-item scale was developed by Morley et al. in 2012. People with a score of 0 points are regarded as normal, 1-2 points as pre-frail, and 3-5 points as frail
Measured: at the enrollment
Berg Balance Scale
Balance was assessed using the BBS, which was developed to measure balance performance. It includes 14 instructions, each of which is scored between 0-4 based on performance of the instruction. The BBS is administered in 10-20 minutes and the maximum score is 56. A score of 0-20 points indicates impaired balance, 21-40 points indicates acceptable balance, and 41-56 points indicates good balance
Measured: at the enrollment
Geriatric Depression Scale-Short Form
The GDS-SF was used to assess the participants' depression level. The scale consists of 15 yes/no questions about the participant's feelings in the past week. Each item is scored 0 or 1, with a higher score indicating the presence of more depressive symptoms
Measured: at the enrollment
Lawton Instrumental Activities of Daily Living Scale
The scale consists of 8 items including information about using the telephone, preparing food, shopping, doing daily household chores, doing laundry, using transport, using drugs, and managing money. Scores range from 0 (dependent) to 8 (independent)
Measured: at the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start11 Jul 2020
- Primary completion27 Sep 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GeriatricsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Halic University
- Investigators
- Seda Saka, PT, PhD, Study director, Haliç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398523
- Sponsor's protocol ID
- ssaka5
- Status last verified
- Aug 2025
- First submitted
- 26 May 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vieira ER, Da Silva RA, Severi MT, Barbosa AC, Amick Iii BC, Zevallos JC, Martinez IL, Chaves PHM. Balance and Gait of Frail, Pre-Frail, and Robust Older Hispanics. Geriatrics (Basel). 2018 Jul 18;3(3):42. doi: 10.3390/geriatrics3030042.
PubMed 31011080Marques LT, Rodrigues NC, Angeluni EO, Dos Santos Pessanha FPA, da Cruz Alves NM, Freire Junior RC, Ferriolli E, de Abreu DCC. Balance Evaluation of Prefrail and Frail Community-Dwelling Older Adults. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):176-182. doi: 10.1519/JPT.0000000000000147.
PubMed 28914718
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Frailty, Balance, and Depression With Activities of Daily Living in Older Adults
- ClinicalTrials.gov ID
- NCT05398523
- Acronym / sponsor ID
- ssaka5
- Conditions
- Geriatrics
- Keywords
- Frailty, balance, depression, activities of daily living
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 11 Jul 2020 (actual)
- Primary completion
- 27 Sep 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 1 Jun 2022 (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 order to maintain independence and prevent disability, it is essential to identify associated factors and reduce functional loss due to concomitant diseases. This study aimed to examine the effects of frailty, balance, and depression on the performance of activities of daily living in older adults. All participants were assessed using the Mini Mental State Test, simple FRAIL scale, Geriatric Depression Scale-Short Form, and Lawton Instrumental Activities of Daily Living Scale (IADL).
Detailed description
As the global population becomes older, the importance of preserving health, function, and quality of life is being increasingly recognized. In order to maintain independence and prevent disability, it is essential to identify associated factors and reduce functional loss due to concomitant diseases. This study aimed to examine the effects of frailty, balance, and depression on the performance of activities of daily living in older adults. All participants were assessed using the Mini Mental State Test, simple FRAIL scale, Geriatric Depression Scale-Short Form, and Lawton Instrumental Activities of Daily Living Scale (IADL).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- adults aged 65 years or older who were registered at Community Health Center No.1 in City Central Amasya.
Key inclusion criteria (3 listed)
- aged 65 years or older
- being able to understand and answer the questionnaires used for data collection
- having mental competency as demonstrated by a score higher than 20 on the Mini Mental State Test
Key exclusion criteria (2 listed)
- limited ambulation
- psychological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini Mental State Test
Time frame: at the enrollment
Cognitive function was assessed using the MMST, which consists of 11 items. The MMST has a maximum score of 30 points; scores above 24 points are considered sufficient and scores lower than 20 indicate cognitive impairment
4 secondary outcomes
FRAIL scale
Time frame: at the enrollment
Berg Balance Scale
Time frame: at the enrollment
Geriatric Depression Scale-Short Form
Time frame: at the enrollment
Lawton Instrumental Activities of Daily Living Scale
Time frame: at the enrollment
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 Aug 2025.
- Results publication: PubMed 31011080Vieira ER, Da Silva RA, Severi MT, Barbosa AC, Amick Iii BC, Zevallos JC, Martinez IL, Chaves PHM. Balance and Gait of Frail, Pre-Frail, and Robust Older Hispanics. Geriatrics (Basel). 2018 Jul 18;3(3):42. doi: 10.3390/geriatrics3030042.
- Results publication: PubMed 28914718Marques LT, Rodrigues NC, Angeluni EO, Dos Santos Pessanha FPA, da Cruz Alves NM, Freire Junior RC, Ferriolli E, de Abreu DCC. Balance Evaluation of Prefrail and Frail Community-Dwelling Older Adults. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):176-182. doi: 10.1519/JPT.0000000000000147.
- Individual participant dataSharing planned: Undecided
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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.
Seda Saka, PT, PhD study director
Haliç 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 Geriatrics, run by Halic 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 3 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 Aug 2025. 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?
Mini Mental State Test (time frame: at the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398523, which also lists 2 linked publications.
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 Aug 2025.