NCT05761665

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

March 9, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

February 27, 2023

Last Update Submit

February 27, 2023

Conditions

Keywords

Accidental FallsAlzheimer DiseaseFrail ElderlyFrailtyKinesiophobiaPostural BalanceWalking Speed

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Alzheimer

Kinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests.

Other: Evaluation

Physically Fragile

Kinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests.

Other: Evaluation

Healthy

Kinesiophobia, Balance, Falling,Walking Speed and Fragility Will be Evaluated with Tests.

Other: Evaluation

Interventions

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

AlzheimerHealthyPhysically Fragile

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Private Dikmen Nursing Home and Private Ulucınar Nursing Home

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseFrailtyKinesiophobia

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety Disorders

Study Officials

  • Meral SERTEL Doc.Dr

    Kırıkkale University

    STUDY DIRECTOR

Central Study Contacts

Beyza Nur Çelik physiotherapist

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

June 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 29, 2024

Last Updated

March 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share