- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06400953
The Effect of Kinetic Brain Exercises on Balance and Dual Task Activities in the Elderly
May 2, 2024 updated by: Arzu Razak Ozdinçler, Fenerbahce University
The aim of the study is to evaluate the balance and dual-task activities of Kinetic Brain Exercises in healthy elderly individuals living in nursing homes.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
A total of 33 people, 4 women and 29 men between the ages of 65-80 (73.88±3.69
years) completed in the research.
Demographic and clinic information of the individuals were recorded and Dual Task Performance Tests for dual task activities, Timed Up and Go Test (TUGT) , Functional Reach Test for balance, 10 Meter Walk Test for walking speed, Fall Efficacy Scale (FES) for the fear of falling, Dual Task Questionnaire for to determine individuals difficulties during dual tasks and World Health Organization Quality of Life Instrument- Older Adults Module (WHOQOL-OLD) was used for quality of life.
Individuals were applied an exercise program of 40 minutes, 2 days a week for 8 weeks.
Individuals were divided into 2 groups.
Kinetic Brain Exercises and Core Stabilization Exercises were applied to Group 1 (n=17), and only Core Stabilization Exercises were applied to Group 2 (n=16).
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Biruni University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Individuals living in nursing homes between the ages of 65-80,
- Having signed the Informed Volunteer Consent Form,
- Sufficient cognitive functions (Mini Mental State Test score being 24 and above)
- Those who can stand independently on their own
Exclusion Criteria:
- Those with neurological, musculoskeletal, inner ear or eye diseases that will cause impairment in vision or standing balance,
- Those with moderate and severe congenital heart disease, coronary heart disease and cerebrovascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Kinetic Brain Exercises and Core Stabilization Exercises were applied to Group 1
|
Kinetic Brain Exercise Program Kinetic brain exercises were applied to Group 1 in groups of 8-10 people, 2 days a week for 40 minutes for 8 weeks.These exercises include warm-up, main and cool-down phases.
Warm-up; These are coordination-oriented movements that include 'brain buttons', 'cross crawl' and 'the thinking cap' exercises.
Main phase; These are exercises that include coordination, selective attention, audio-visual focus and balance, consisting of perceptual, independent and dependent movements.
Cooling phase; It aims to ensure hand-eye coordination by consisting of double doodle, throwing balls to each other and lazy 8s exercises.Exercises were selected from the kinetic brain exercise pool, modified and applied for 2-8 weeks.The exercises were done while sitting and standing, with increasing difficulty levels.
The factor that made the levels difficult was the time and complexity of the incoming command.
A game ball with a diameter of 7 cm was used for the exercises.
Core Stabilization Exercise Program in groups of 8-10 people, for 40 minutes, 2 days a week, for 8 weeks.These exercises included a 5-minute active warm-up, a 30-minute Core Stabilization exercise that included upper and lower extremity movements, and immediately followed by a 5-minute cool-down exercise.The exercises are pilates-based and in the first stage of the program.
Movements were performed in standing and sitting positions.Movements were started with 6-8 repetitions, increased by 1-2 repetitions each week, and in the last week, 12-15 repetitions were performed, with contraction times increasing from 5 seconds to 10 seconds.
As the exercises progressed from easy to difficult, from simple movements to complex movements, the movements were continued by adding an elastic band and 0.5 kg weight.While advancing the exercise program, the exercises were personalized by taking into account the individual's strain levels.
|
|
Experimental: Group 2
Core Stabilization Exercises were applied to Group 2
|
Core Stabilization Exercise Program in groups of 8-10 people, for 40 minutes, 2 days a week, for 8 weeks.These exercises included a 5-minute active warm-up, a 30-minute Core Stabilization exercise that included upper and lower extremity movements, and immediately followed by a 5-minute cool-down exercise.The exercises are pilates-based and in the first stage of the program.
Movements were performed in standing and sitting positions.Movements were started with 6-8 repetitions, increased by 1-2 repetitions each week, and in the last week, 12-15 repetitions were performed, with contraction times increasing from 5 seconds to 10 seconds.
As the exercises progressed from easy to difficult, from simple movements to complex movements, the movements were continued by adding an elastic band and 0.5 kg weight.While advancing the exercise program, the exercises were personalized by taking into account the individual's strain levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic and Clinical Evaluation Form
Time Frame: At baseline and after 8 weeks
|
Name-surname, age, telephone number, gender, education level, height, weight, Body Mass Index (BMI), presence of chronic disease, regular medication use, whether or not they have a hobby, duration of stay in the nursing home, reason for staying in the nursing home and use of assistive walking devices were questioned.
|
At baseline and after 8 weeks
|
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Mini Mental State Test
Time Frame: At baseline and after 8 weeks
|
Cognitive status was evaluated.
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At baseline and after 8 weeks
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Dual Task Performance Tests
Time Frame: At baseline and after 8 weeks
|
To evaluate dual-task activities, Timed Up and Go Test, 30-Second Sit-and-Go Test, Tandem Stance Test, 360° Rotation Test and One-Leg Stand Test were applied to individuals in three different ways: single task, cognitive task and motor task, and performance times were measured.
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At baseline and after 8 weeks
|
|
10 Meter Walking Test
Time Frame: At baseline and after 8 weeks
|
It was used to evaluate individuals' walking speed.
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At baseline and after 8 weeks
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Functional Reaching Test
Time Frame: At baseline and after 8 weeks
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It was used to evaluate the balance performance of individuals.
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At baseline and after 8 weeks
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Dual Task Survey
Time Frame: At baseline and after 8 weeks
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It was used to obtain information about the difficulties individuals experience in daily life situations that require dual tasks.
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At baseline and after 8 weeks
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Tinetti Fall Activity Scale
Time Frame: At baseline and after 8 weeks
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It was used to assess individuals' fear of falling.Minimum score is 0 and maximum score is 28.
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At baseline and after 8 weeks
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World Health Organization Quality of Life Scale Elderly Module
Time Frame: At baseline and after 8 weeks
|
It was used to evaluate the quality of life of the elderly.
Minimum score is 0 and maximum score is 135.
|
At baseline and after 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2023
Primary Completion (Actual)
February 15, 2024
Study Completion (Actual)
March 15, 2024
Study Registration Dates
First Submitted
April 28, 2024
First Submitted That Met QC Criteria
May 2, 2024
First Posted (Actual)
May 6, 2024
Study Record Updates
Last Update Posted (Actual)
May 6, 2024
Last Update Submitted That Met QC Criteria
May 2, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Brain Exercises in the Elderly
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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