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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05761665
Other study ID # KirikkaleU-FTR-BNC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2023
Est. completion date February 29, 2024

Study information

Verified date February 2023
Source Kirikkale University
Contact Beyza Nur Çelik physiotherapist
Phone 905064513077
Email beyzancelik97@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 54
Est. completion date February 29, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Evaluation
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
6 months
Primary 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.
6 months
Primary 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. 6 months
Primary 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. 6 months
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