Aging ProblemsNCT04873791
Comparison of the Effects of Different Living Environments in Geriatric Individuals: A Pilot Study
An observational study of Aging Problems and Balance; Distorted, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
In Turkey, 63% of geriatric people who make up approximately 8.3% of the entire population live in their own living environment, 36% live with their children and 1% live in nursing homes. The number of individuals living in nursing homes is increasing as the nuclear family structure becomes more evident. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Problems, Balance; Distorted, Pain
- What is being tested?
- Assessment of geriatric individuals living in home environment and nursing home.
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2016to 8 Jun 2017
- How long will I take part?
- 2 Days
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Geriatric individuals, either living in home environment or a nursing home in Istanbul.
Who may be able to join
- Volunteering to research,
- Being in the age range of 65-95,
- Individuals with no known health problems, caused inactivity.
- Adequate cognitive functions (Standardized Mini Mental Test score of 24 and above).
- Individuals who do not have musculoskeletal problems that prevent physical activity.
- Giving the informed consent.
Who cannot join
- Mental retardation
- Epileptic history
- Those with diseases that cause neurological, orthopedic, and musculoskeletal problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cognitive Function, Balance, Quality of Life, Depression and Daily Living Activities of Geriatric Individuals Living in Home Environment and Nursing Home.
In Turkey, 63% of geriatric people who make up approximately 8.3% of the entire population live in their own living environment, 36% live with their children and 1% live in nursing homes. The number of individuals living in nursing homes is increasing as the nuclear family structure becomes more evident. National Social Security programs give special importance to nursing home restructuring and Social Health Policy aims to increase practices related to "aging in place" and "Active and Healthy Ageing" for geriatric individuals. In this context, projects aimed at preventing secondary negative symptoms in aging and supporting the quality aging process are outstanding.
The aim of this study is to assess and compare cognitive functions, balance, musculoskeletal pain severity, psychological state, participation level in activities of daily living, and quality of life of geriatric individuals living different environments.
Read the detailed description
Aging is a process that negatively affects the individual physiologically, psychologically, and socially. Degenerative changes in the musculoskeletal system cause joint pain, limitations, restrictions on activity participation, and physical and social dependence. Neurodegenerative processes, on the other hand, lead to loss of cognitive functions, balance, and coordination. The decrease in biological and social motives and the gradual increase in social and physiological losses, lead to dependence in the activities of daily living, worsening psychological condition, and deteriorating quality of life. With this process, the caregiver burden increases economically and socially.
Today, there is a growing proportion of geriatric individuals in society. According to 2015 data from the World Health Organization, 900 million geriatric individuals live on earth. According to a population projection made by the WHO in 2018, the elderly population is estimated to reach around 2 billion people out of 900 million people by 2050. These data show that 22% of society will be made up of older individuals by 2050.
There were no studies that investigated the effects of different living environments thoroughly on geriatric individuals.The purpose of this research is to evaluate and compare cognitive functions, balance, musculoskeletal pain level, psychological state, participation level in activities of daily living, and quality of life of elderly people living at home and elderly people living in nursing homes in Turkey.
The Aim of This Study Is: To assess and compare of cognitive function, balance, quality of life, depression and daily living activities of geriatric individuals, living in home environment and nursing home
- Conditions
- Aging Problems, Balance; Distorted, Pain, Quality of Life
- Being tested
- Assessment of geriatric individuals living in home environment and nursing home.
- Keywords
- Geriatric individuals, Nursing home, Home environment, Balance, Pain, Quality of life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of geriatric individuals living in home environment and nursing home.Diagnostic test
Assessments explained in the arm section were made as described in one session in both group
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Assessment Geriatric Individuals Living at Home were joined in Group 1.
Demographic and social characteristics, cognitive functions, balance, pain, depression, quality of life, and activities of daily living of elderly individuals living in a nursing home and home environment were evaluated.
Demographic information of all subjects (age, gender, educational status, occupation, body weight, height, body mass index), Standardized Mini-Mental Test (SMMT) score, Visual Analog Scale (VAS) score, Berg Balance Scale (BBS) score, Geriatric Depression Scale (GDS) score, Barthel Index score, Short Form-36 (SF-36) score were used for evaluations.
Assessments were made as described in section of outcome measures, in one session. Receives: Diagnostic Test: Assessment of geriatric individuals living in home environment and nursing home. | |
| Group 2 | Assessment Geriatric Individuals Living in Nursing Home were joined in Group 2. Demographic and social characteristics, cognitive functions, balance, pain, depression, quality of life, and activities of daily living of elderly individuals living in a nursing home and home environment were evaluated.
Demographic information of all subjects (age, gender, educational status, occupation, body weight, height, body mass index), Standardized Mini-Mental Test (SMMT) score, Visual Analog Scale (VAS) score, Berg Balance Scale (BBS) score, Geriatric Depression Scale (GDS) score, Barthel Index score, Short Form-36 (SF-36) score were used for evaluations.
Assessments were made as described in section of outcome measures, in one session. Receives: Diagnostic Test: Assessment of geriatric individuals living in home environment and nursing home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance evaluation
Standardized Mini Mental Test (SMMT) was used. It is used for the quantitative evaluation of cognitive performance within the standard neuropsychiatric examination methods. The test is a short, useful, and a standardized method that can be used globally to determine the cognitive level. It is evaluated in 11 items and under 5 main titles and over a total of 30 points. Low score refers to severe cognitive impairment.
Measured: 10 minutes after obtaining socio-demographic information (It was done between the 10th and 25th minutes of the assessment)
Pain severity assessment
Visual Analogue Scale (VAS) that is an easy, reproducible, minimal tool-requiring, and understandable measurement tool for the assessment of pain intensity was used. This scale consists of a horizontal, straight line. There is a value of 0 at the beginning of the line and 10 at the end.
Measured: 25 minutes after obtaining socio-demographic information (It was done between the 25th and 30th minutes of the assessment)
Balance assessment
Berg Balance Scale (BDI) was used to measure balance performance in geriatric individuals. It is often used in clinical trials to assess postural control and predict the risk of falls. The test is made difficult by reducing the ground support. This test consists of 14 items and each section is rated between 0 (bad) and 4 (best). The high score indicates the best balance. 0-20 indicates high risk, 21-40 indicates moderate risk and 41-64 indicates low risk.
Measured: 30 minutes after obtaining socio-demographic information. After the visual analogue scale evaluation, the geriatric individuals were rested for 5 minutes (It was done between the 35th and 50th minutes of the assessment).
Evaluation of Depression score
Geriatric Depression Scale (GDS) was used. It consists of 30 self-report questions. In the scoring of the scale, 1 point is given to each answer that suggests depression, and 0 is given for the other answers, and the final score is considered as the depression score. A cut off value of 0-10 was defined as the absence of depression, 11-13 as "probable depression," and 14 and above as "definite depression."
Measured: 50 minutes after obtaining socio-demographic information (It was done between the 50th and 60th minutes of the assessment).
Activities of daily living
Barthel Index (BI) was used. The Barthel index consists of 10 main items. The items measure feeding, transferring from bed to wheelchair and to and from a toilet, grooming, bathing, walking on a level surface (or propelling a wheelchair if unable to walk), going up and down the stairs, dressing and undressing, controlling bladder and controlling bowel. The total score is between 0 and 100 and scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, 91-99 indicates "slight" dependency and 100 indicate "total" independency.
Measured: 60 minutes after obtaining socio-demographic information. After the geriatric depression scale evaluation, the geriatric individuals were rested for 5 minutes. (It was done between the 65th and 70th minutes of the assessment).
Assessment of Quality of life
Short Form 36 (SF-36) was used. It is a scale that has a generic scale feature and provides extensive measurement. It consists of 36 questions under 8 subheadings. Low scores indicate deterioration in the quality of life.
Measured: It was completed after 70 minutes obtaining socio-demographic information.
Secondary outcomes (2)
Body mass index
Body mass index (BMI) is an inexpensive and easy screening method for weight category. It was calculated with person's weight in kilograms divided by the square of height in meters.
Measured: After the permission of patients, it was calculated, in the first 10 minutes of assessment.
Using of walking aids
Whether the participant used a walking aid or not was recorded.
Measured: After the permission of patients, it was calculated, in the first 10 minutes of assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start29 Apr 2016
- Primary completion23 May 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aysel Yildiz Ozer, PT, PhD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873791
- Sponsor's protocol ID
- 10156977
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cognitive Function, Balance, Quality of Life, Depression and Daily Living Activities of Geriatric Individuals Living in Home Environment and Nursing Home.
- ClinicalTrials.gov ID
- NCT04873791
- Acronym / sponsor ID
- 10156977
- Conditions
- Aging Problems, Balance; Distorted, Pain, Quality of Life
- Keywords
- Geriatric individuals, Nursing home, Home environment, Balance, Pain, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 5 May 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 Turkey, 63% of geriatric people who make up approximately 8.3% of the entire population live in their own living environment, 36% live with their children and 1% live in nursing homes. The number of individuals living in nursing homes is increasing as the nuclear family structure becomes more evident. National Social Security programs give special importance to nursing home restructuring and Social Health Policy aims to increase practices related to "aging in place" and "Active and Healthy Ageing" for geriatric individuals. In this context, projects aimed at preventing secondary negative symptoms in aging and supporting the quality aging process are outstanding.
The aim of this study is to assess and compare cognitive functions, balance, musculoskeletal pain severity, psychological state, participation level in activities of daily living, and quality of life of geriatric individuals living different environments.
Detailed description
Aging is a process that negatively affects the individual physiologically, psychologically, and socially. Degenerative changes in the musculoskeletal system cause joint pain, limitations, restrictions on activity participation, and physical and social dependence. Neurodegenerative processes, on the other hand, lead to loss of cognitive functions, balance, and coordination. The decrease in biological and social motives and the gradual increase in social and physiological losses, lead to dependence in the activities of daily living, worsening psychological condition, and deteriorating quality of life. With this process, the caregiver burden increases economically and socially.
Today, there is a growing proportion of geriatric individuals in society. According to 2015 data from the World Health Organization, 900 million geriatric individuals live on earth. According to a population projection made by the WHO in 2018, the elderly population is estimated to reach around 2 billion people out of 900 million people by 2050. These data show that 22% of society will be made up of older individuals by 2050.
There were no studies that investigated the effects of different living environments thoroughly on geriatric individuals.The purpose of this research is to evaluate and compare cognitive functions, balance, musculoskeletal pain level, psychological state, participation level in activities of daily living, and quality of life of elderly people living at home and elderly people living in nursing homes in Turkey.
The Aim of This Study Is: To assess and compare of cognitive function, balance, quality of life, depression and daily living activities of geriatric individuals, living in home environment and nursing home
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Assessment of geriatric individuals living in home environment and nursing home.Assessment Geriatric Individuals Living at Home were joined in Group 1. Demographic and social characteristics, cognitive functions, balance, pain, depression, quality of life, and activities of daily living of elderly individuals living in a nursing home and home environment were evaluated. Demographic information of all subjects (age, gender, educational status, occupation, body weight, height, body mass index), Standardized Mini-Mental Test (SMMT) score, Visual Analog Scale (VAS) score, Berg Balance Scale (BBS) score, Geriatric Depression Scale (GDS) score, Barthel Index score, Short Form-36 (SF-36) score were used for evaluations. Assessments were made as described in section of outcome measures, in one session. |
| Group 2 | – | Diagnostic Test: Assessment of geriatric individuals living in home environment and nursing home.Assessment Geriatric Individuals Living in Nursing Home were joined in Group 2. Demographic and social characteristics, cognitive functions, balance, pain, depression, quality of life, and activities of daily living of elderly individuals living in a nursing home and home environment were evaluated. Demographic information of all subjects (age, gender, educational status, occupation, body weight, height, body mass index), Standardized Mini-Mental Test (SMMT) score, Visual Analog Scale (VAS) score, Berg Balance Scale (BBS) score, Geriatric Depression Scale (GDS) score, Barthel Index score, Short Form-36 (SF-36) score were used for evaluations. Assessments were made as described in section of outcome measures, in one session. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Geriatric individuals, either living in home environment or a nursing home in Istanbul.
Key inclusion criteria (6 listed)
- Volunteering to research,
- Being in the age range of 65-95,
- Individuals with no known health problems, caused inactivity.
- Adequate cognitive functions (Standardized Mini Mental Test score of 24 and above).
- Individuals who do not have musculoskeletal problems that prevent physical activity.
Key exclusion criteria (3 listed)
- Mental retardation
- Epileptic history
- Those with diseases that cause neurological, orthopedic, and musculoskeletal problems.
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 |
|---|---|---|
| Assessment of geriatric individuals living in home environment and nursing home.Assessments explained in the arm section were made as described in one session in both group | Diagnostic test | Group 1, Group 2 |
Primary outcome
Cognitive performance evaluation
Time frame: 10 minutes after obtaining socio-demographic information (It was done between the 10th and 25th minutes of the assessment)
Standardized Mini Mental Test (SMMT) was used. It is used for the quantitative evaluation of cognitive performance within the standard neuropsychiatric examination methods. The test is a short, useful, and a standardized method that can be used globally to determine the cognitive level. It is evaluated in 11 items and under 5 main titles and over a total of 30 points. Low score refers to severe cognitive impairment.
Pain severity assessment
Time frame: 25 minutes after obtaining socio-demographic information (It was done between the 25th and 30th minutes of the assessment)
Visual Analogue Scale (VAS) that is an easy, reproducible, minimal tool-requiring, and understandable measurement tool for the assessment of pain intensity was used. This scale consists of a horizontal, straight line. There is a value of 0 at the beginning of the line and 10 at the end.
Balance assessment
Time frame: 30 minutes after obtaining socio-demographic information. After the visual analogue scale evaluation, the geriatric individuals were rested for 5 minutes (It was done between the 35th and 50th minutes of the assessment).
Berg Balance Scale (BDI) was used to measure balance performance in geriatric individuals. It is often used in clinical trials to assess postural control and predict the risk of falls. The test is made difficult by reducing the ground support. This test consists of 14 items and each section is rated between 0 (bad) and 4 (best). The high score indicates the best balance. 0-20 indicates high risk, 21-40 indicates moderate risk and 41-64 indicates low risk.
Evaluation of Depression score
Time frame: 50 minutes after obtaining socio-demographic information (It was done between the 50th and 60th minutes of the assessment).
Geriatric Depression Scale (GDS) was used. It consists of 30 self-report questions. In the scoring of the scale, 1 point is given to each answer that suggests depression, and 0 is given for the other answers, and the final score is considered as the depression score. A cut off value of 0-10 was defined as the absence of depression, 11-13 as "probable depression," and 14 and above as "definite depression."
Activities of daily living
Time frame: 60 minutes after obtaining socio-demographic information. After the geriatric depression scale evaluation, the geriatric individuals were rested for 5 minutes. (It was done between the 65th and 70th minutes of the assessment).
Barthel Index (BI) was used. The Barthel index consists of 10 main items. The items measure feeding, transferring from bed to wheelchair and to and from a toilet, grooming, bathing, walking on a level surface (or propelling a wheelchair if unable to walk), going up and down the stairs, dressing and undressing, controlling bladder and controlling bowel. The total score is between 0 and 100 and scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, 91-99 indicates "slight" dependency and 100 indicate "total" independency.
Assessment of Quality of life
Time frame: It was completed after 70 minutes obtaining socio-demographic information.
Short Form 36 (SF-36) was used. It is a scale that has a generic scale feature and provides extensive measurement. It consists of 36 questions under 8 subheadings. Low scores indicate deterioration in the quality of life.
2 secondary outcomes
Body mass index
Time frame: After the permission of patients, it was calculated, in the first 10 minutes of assessment.
Using of walking aids
Time frame: After the permission of patients, it was calculated, in the first 10 minutes of assessment.
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 5 May 2021.
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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.
Aysel Yildiz Ozer, PT, PhD study director
Marmara 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 Aging Problems and Balance; Distorted, run by Marmara 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 6 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 5 May 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?
Cognitive performance evaluation (time frame: 10 minutes after obtaining socio-demographic information (It was done between the 10th and 25th minutes of the assessment)). 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 5 May 2021.