Alzheimer DiseaseNCT05761665
Comparison of Kinesiophobia, Balance, Falling and Walking Speeds of Elderly's With Physical Frailty With Alzheimer's
An observational study of Alzheimer Disease and Frail Elderly Syndrome, run by Kırıkkale University.
Trial summary
In this study, Kinesiophobia, Balance, Falling, Walking Speeds of Elderly People with Cognitive Frailty with Alzheimer's Dementia, Elderly with Physical Frailty and Healthy Elderly Individuals will be compared. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Frail Elderly Syndrome
- What is being tested?
- Evaluation
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to 29 Feb 2024
- 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: Private Dikmen Nursing Home and Private Ulucınar Nursing Home
Who may be able to join
- being over the age of 65 and being able to walk independently.
- Individuals who have been diagnosed with early or mid-stage Alzheimer's by a physician.
- Appearing fragile or pre-frail according to the Frail Questionnaire.
Who cannot join
- Who has an obstacle to doing physical activity.
- Those who have undergone an operation in the last 6 months.
- Those who do not agree to participate in the research.
- Those who have been diagnosed with late-stage Alzheimer's dementia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Kinesiophobia, Balance, Falling and Walking Speeds of the Cognitively Frail Elderly With Alzheimer's Dementia With the Physically Fragile Elderly.
In this study, Kinesiophobia, Balance, Falling, Walking Speeds of Elderly People with Cognitive Frailty with Alzheimer's Dementia, Elderly with Physical Frailty and Healthy Elderly Individuals will be compared.
Read the detailed description
In this study, Kinesiophobia, Balance, Falling, Walking Speeds of Elderly People with Cognitive Frailty with Alzheimer's Dementia, Elderly with Physical Frailty and Healthy Elderly Individuals will be compared.
For research, 3 Groups will be included, including elderly individuals diagnosed with Alzheimer's Dementia, physically fragile elderly individuals and healthy elderly individuals staying at the Private Dikmen Nursing Home and the private Uluçınar Nursing Home. The research will be conducted with a total of 54 individuals who voluntarily participated in the study from June 2023 to February 2024.
The criteria for participation in the study of elderly individuals diagnosed with 1st group Alzheimer's Dementia are to be over 65 years old, to be able to walk independently and to be diagnosed with early or middle stage Alzheimer's by a doctor.
The criteria for participation in the study of physically frail elderly individuals for 2nd group is to be over 65 years old, to be able to walk independently and appearing fragile or pre-frail according to the Frail Questionnaire.
The criteria for participation in the study of the 3rd group of healthy elderly individuals were to be over 65 years old, not to have any psychiatric, neurological and orthopedic problems, and to be able to walk independently.
As a data collection tool; For the descriptive characteristics of the patients, a form containing demographic information will be used. Timed Up and Go Test, Berg Balance Scale, 2 Minutes Walking Test will be used to evaluate balance and gait. Frail Questionnaire and Clinical Frailty Scale will be used for the evaluation of frailty.
Tampa Scale will be used for kinesiophobia assessment. The Fall Activity Scale (Tinetti) will be used to assess the fear of falling. In addition, the cognitive status of individuals will be evaluated with the Mini Mental State Test and the Montreal Cognitive Assessment Test.
- Conditions
- Alzheimer Disease, Frail Elderly Syndrome
- Being tested
- Evaluation
- Keywords
- Accidental Falls, Alzheimer Disease, Frail Elderly, Frailty, Kinesiophobia, Postural Balance, Walking Speed
- Medical subject headings
- Alzheimer Disease, Frailty, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Kinesiophobia=Tampa scale Balance=Berg Balance Scale Falling=The Fall Activity Scale( Tinetti) Walking speed=Timed Get Up and Walk Test ,Two-Minute Walking Test Fragility=Frail Fragility Questionnaire, Clinical Fragility Scale
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer | Kinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests. Receives: Other: Evaluation | |
| Physically Fragile | Kinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests. Receives: Other: Evaluation | |
| Healthy | Kinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
It is a scale consisting of 14 tests that measure the ability to maintain balance during different positions, postural changes and movement.The assessment is based on the individual's ability to perform each test independently and/or within a specified time or distance.Grading is made between 0 and 4 points. It is expressed as 0 = unable, 4 = normal performance.
The highest score is 56.0 to 20 points; indicates that the person is wheelchair dependent and has a 100% risk of falling.Between 21-40 points; It indicates that the person can walk with assistance as there is a risk of falling.between 41-56 points; states that they can ambulate independently with very little risk of falling.
It was designed to evaluate the risk of falling in geriatrics.
Measured: 6 months
Falls efficacy scale(Tinetti)
Tinettti et al. can be measured, the person's activities of daily living (for example, cleaning the house, getting dressed, doing simple shopping, etc.) 10-item questionnaire to evaluate the efficacy level of elderly individuals by looking at their safety.
They developed the Tinetti Fall Efficiency Scale.How confident are you that you are doing the following activities without falling, while performing daily life activities in 10 different activities "on a scale of 1 to 10, 1 is very confident and 10 is not confident at all?' he does the questioning.Adding the scores gives a total score of 10 (low fall-related activity) to 100 (high fall-related activity).A total score above 70 indicates that the person has a fear of falling.
Measured: 6 months
Tampa Kinesiophobia Scale
It is a 17-item scale developed to measure the fear of movement/re-injury.The scale includes parameters for injury/re-injury and fear-avoidance in work-related activities.Likert 4 points on the scale rating (1= Strongly disagree, 4= I completely agree) is used.4, 8, 12 and After the reversal of Article 16, a total points are calculated.Person between 17-68 total gets a score. The score that the person received on the scale his high level of kinesiophobia is also high shows.
Measured: 6 months
Timed Get Up and Walk Test
The patient is asked to get up from the chair she is sitting on, walk three meters, turn around and sit down again.At this time, the time is recorded.10 seconds and below; the patient walks independently, the risk of falling is very low.11-19 sec.; The patient walks independently, there is a low to moderate risk of falling.20-29 sec. may need help from time to time, there is a moderate to high risk of falling.Over 30 seconds, assistance is needed from time to time and the risk of falling is high.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study startJun 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Nur Celik, Kırıkkale University
- Investigators
- Meral SERTEL Doc.Dr, Study director, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761665
- Sponsor's protocol ID
- KirikkaleU-FTR-BNC
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 9 Mar 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Kinesiophobia, Balance, Falling and Walking Speeds of the Cognitively Frail Elderly With Alzheimer's Dementia With the Physically Fragile Elderly.
- ClinicalTrials.gov ID
- NCT05761665
- Acronym / sponsor ID
- KirikkaleU-FTR-BNC
- Conditions
- Alzheimer Disease, Frail Elderly Syndrome
- Keywords
- Accidental Falls, Alzheimer Disease, Frail Elderly, Frailty, Kinesiophobia, Postural Balance, Walking Speed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 9 Mar 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.
In this study, Kinesiophobia, Balance, Falling, Walking Speeds of Elderly People with Cognitive Frailty with Alzheimer's Dementia, Elderly with Physical Frailty and Healthy Elderly Individuals will be compared.
Detailed description
In this study, Kinesiophobia, Balance, Falling, Walking Speeds of Elderly People with Cognitive Frailty with Alzheimer's Dementia, Elderly with Physical Frailty and Healthy Elderly Individuals will be compared.
For research, 3 Groups will be included, including elderly individuals diagnosed with Alzheimer's Dementia, physically fragile elderly individuals and healthy elderly individuals staying at the Private Dikmen Nursing Home and the private Uluçınar Nursing Home. The research will be conducted with a total of 54 individuals who voluntarily participated in the study from June 2023 to February 2024.
The criteria for participation in the study of elderly individuals diagnosed with 1st group Alzheimer's Dementia are to be over 65 years old, to be able to walk independently and to be diagnosed with early or middle stage Alzheimer's by a doctor.
The criteria for participation in the study of physically frail elderly individuals for 2nd group is to be over 65 years old, to be able to walk independently and appearing fragile or pre-frail according to the Frail Questionnaire.
The criteria for participation in the study of the 3rd group of healthy elderly individuals were to be over 65 years old, not to have any psychiatric, neurological and orthopedic problems, and to be able to walk independently.
As a data collection tool; For the descriptive characteristics of the patients, a form containing demographic information will be used. Timed Up and Go Test, Berg Balance Scale, 2 Minutes Walking Test will be used to evaluate balance and gait. Frail Questionnaire and Clinical Frailty Scale will be used for the evaluation of frailty.
Tampa Scale will be used for kinesiophobia assessment. The Fall Activity Scale (Tinetti) will be used to assess the fear of falling. In addition, the cognitive status of individuals will be evaluated with the Mini Mental State Test and the Montreal Cognitive Assessment Test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer | – | Other: EvaluationKinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests. |
| Physically Fragile | – | Other: EvaluationKinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests. |
| Healthy | – | Other: EvaluationKinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Private Dikmen Nursing Home and Private Ulucınar Nursing Home
Key inclusion criteria (3 listed)
- being over the age of 65 and being able to walk independently.
- Individuals who have been diagnosed with early or mid-stage Alzheimer's by a physician.
- Appearing fragile or pre-frail according to the Frail Questionnaire.
Key exclusion criteria (4 listed)
- Who has an obstacle to doing physical activity.
- Those who have undergone an operation in the last 6 months.
- Those who do not agree to participate in the research.
- Those who have been diagnosed with late-stage Alzheimer's dementia.
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 |
|---|---|---|
| EvaluationKinesiophobia=Tampa scale Balance=Berg Balance Scale Falling=The Fall Activity Scale( Tinetti) Walking speed=Timed Get Up and Walk Test ,Two-Minute Walking Test Fragility=Frail Fragility Questionnaire, Clinical Fragility Scale | Other | Alzheimer, Healthy, Physically Fragile |
Primary outcome
Berg Balance Scale
Time frame: 6 months
It is a scale consisting of 14 tests that measure the ability to maintain balance during different positions, postural changes and movement.The assessment is based on the individual's ability to perform each test independently and/or within a specified time or distance.Grading is made between 0 and 4 points. It is expressed as 0 = unable, 4 = normal performance. The highest score is 56.0 to 20 points; indicates that the person is wheelchair dependent and has a 100% risk of falling.Between 21-40 points; It indicates that the person can walk with assistance as there is a risk of falling.between 41-56 points; states that they can ambulate independently with very little risk of falling. It was designed to evaluate the risk of falling in geriatrics.
Falls efficacy scale(Tinetti)
Time frame: 6 months
Tinettti et al. can be measured, the person's activities of daily living (for example, cleaning the house, getting dressed, doing simple shopping, etc.) 10-item questionnaire to evaluate the efficacy level of elderly individuals by looking at their safety. They developed the Tinetti Fall Efficiency Scale.How confident are you that you are doing the following activities without falling, while performing daily life activities in 10 different activities "on a scale of 1 to 10, 1 is very confident and 10 is not confident at all?' he does the questioning.Adding the scores gives a total score of 10 (low fall-related activity) to 100 (high fall-related activity).A total score above 70 indicates that the person has a fear of falling.
Tampa Kinesiophobia Scale
Time frame: 6 months
It is a 17-item scale developed to measure the fear of movement/re-injury.The scale includes parameters for injury/re-injury and fear-avoidance in work-related activities.Likert 4 points on the scale rating (1= Strongly disagree, 4= I completely agree) is used.4, 8, 12 and After the reversal of Article 16, a total points are calculated.Person between 17-68 total gets a score. The score that the person received on the scale his high level of kinesiophobia is also high shows.
Timed Get Up and Walk Test
Time frame: 6 months
The patient is asked to get up from the chair she is sitting on, walk three meters, turn around and sit down again.At this time, the time is recorded.10 seconds and below; the patient walks independently, the risk of falling is very low.11-19 sec.; The patient walks independently, there is a low to moderate risk of falling.20-29 sec. may need help from time to time, there is a moderate to high risk of falling.Over 30 seconds, assistance is needed from time to time and the risk of falling is high.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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.
Meral SERTEL Doc.Dr study director
Kırıkkale University
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Frail Elderly Syndrome, run by Kırıkkale University.
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 4 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: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beyza Nur Çelik physiotherapist (905064513077, beyzancelik97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 6 months). The study lists 4 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 9 Mar 2023.