ElderlyNCT06400953
The Effect of Kinetic Brain Exercises on Balance and Dual Task Activities in the Elderly
A study testing Kinetic Brain Exercises and Core Stabilization Exercises and Core Stabilization Exercises in people with Elderly and Exercise, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Kinetic Brain Exercises and Core Stabilization Exercises and Core Stabilization Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Mar 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- Kinetic Brain Exercises and Core Stabilization Exercises, Core Stabilization Exercises
- Keywords
- Kinetic Brain Exercises, Balance, Dual Task Performance, Elderly, Core Stabilization
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinetic Brain Exercises and Core Stabilization ExercisesOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Kinetic Brain Exercises and Core Stabilization Exercises were applied to Group 1 Receives: Other: Kinetic Brain Exercises and Core Stabilization Exercises; Other: Core Stabilization Exercises |
| Group 2 | Experimental | Core Stabilization Exercises were applied to Group 2 Receives: Other: Core Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and Clinical Evaluation Form
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.
Measured: At baseline and after 8 weeks
Mini Mental State Test
Cognitive status was evaluated.
Measured: At baseline and after 8 weeks
Dual Task Performance Tests
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.
Measured: At baseline and after 8 weeks
10 Meter Walking Test
It was used to evaluate individuals' walking speed.
Measured: At baseline and after 8 weeks
Functional Reaching Test
It was used to evaluate the balance performance of individuals.
Measured: At baseline and after 8 weeks
Dual Task Survey
It was used to obtain information about the difficulties individuals experience in daily life situations that require dual tasks.
Measured: At baseline and after 8 weeks
Tinetti Fall Activity Scale
It was used to assess individuals' fear of falling.Minimum score is 0 and maximum score is 28.
Measured: At baseline and after 8 weeks
World Health Organization Quality of Life Scale Elderly Module
It was used to evaluate the quality of life of the elderly. Minimum score is 0 and maximum score is 135.
Measured: At baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 Dec 2023
- Primary completion15 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Razak Ozdinçler, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400953
- Sponsor's protocol ID
- Brain Exercises in the Elderly
- Status last verified
- May 2024
- First submitted
- 28 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinetic Brain Exercises on Balance and Dual Task Activities in the Elderly
- ClinicalTrials.gov ID
- NCT06400953
- Acronym / sponsor ID
- Brain Exercises in the Elderly
- Keywords
- Kinetic Brain Exercises, Balance, Dual Task Performance, Elderly, Core Stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 6 May 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Kinetic Brain Exercises and Core Stabilization Exercises, Other: Core Stabilization ExercisesKinetic Brain Exercises and Core Stabilization Exercises were applied to Group 1 |
| Group 2 | Experimental | Other: Core Stabilization ExercisesCore Stabilization Exercises were applied to Group 2 |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Kinetic Brain Exercises and Core Stabilization ExercisesKinetic 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 | Group 1 |
| Core Stabilization ExercisesCore 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. | Other | Group 1, Group 2 |
Primary outcome
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.
Mini Mental State Test
Time frame: At baseline and after 8 weeks
Cognitive status was evaluated.
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.
10 Meter Walking Test
Time frame: At baseline and after 8 weeks
It was used to evaluate individuals' walking speed.
Functional Reaching Test
Time frame: At baseline and after 8 weeks
It was used to evaluate the balance performance of individuals.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinetic Brain Exercises and Core Stabilization Exercises and Core Stabilization Exercises in people with Elderly and Exercise, run by Fenerbahce University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and Clinical Evaluation Form (time frame: At baseline and after 8 weeks). The study lists 8 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 6 May 2024.