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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Istanbul, Turkey
        • Biruni University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Kinetic Brain Exercises and Core Stabilization Exercises were applied to Group 1
Other: Kinetic Brain Exercises and Core Stabilization Exercises
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.
Other: Core Stabilization 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
Other: Core Stabilization 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Mini Mental State Test
Time Frame: At baseline and after 8 weeks
Cognitive status was evaluated.
At baseline and after 8 weeks
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.
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.
At baseline and after 8 weeks
Functional Reaching Test
Time Frame: At baseline and after 8 weeks
It was used to evaluate the balance performance of individuals.
At baseline and after 8 weeks
Dual Task Survey
Time Frame: At baseline and after 8 weeks
It was used to obtain information about the difficulties individuals experience in daily life situations that require dual tasks.
At baseline and after 8 weeks
Tinetti Fall Activity Scale
Time Frame: At baseline and after 8 weeks
It was used to assess individuals' fear of falling.Minimum score is 0 and maximum score is 28.
At baseline and after 8 weeks
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fenerbahce University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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