BalancegeriatricNCT05333172
The Effect Of Balance Training With Dual Task On Cognitive Status And Functionality In Elderly
A study testing Dual task exercises in people with Balance and Cognitive Functions, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Aging is a dynamic process that affects motor and cognitive functions. Activities of daily living and functionality, including dual task performance, are also negatively affected by these functions. The purpose of this study is to determine of balance training with dual task on cognitive function and functionality. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Balance, Cognitive Functions, Dual Task
- What is being tested?
- Dual task exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2016to 28 Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being between the ages of 65-85
- Being able to communicate
- Able to walk without mobility aids
- Be volunteer for intervention
Who cannot join
- Cognitive impairment (<17 point on the Minimal Mental State Examination )
- In physiotherapy treatment that trains balance
- Balance impairment (< 20 point on the berg balance test)
- having an orthopedic problem that may affect balance performance
Trial locations and contacts
1 site in 1 country.
About this study
Aging is a dynamic process that affects motor and cognitive functions. Activities of daily living and functionality, including dual task performance, are also negatively affected by these functions. The purpose of this study is to determine of balance training with dual task on cognitive function and functionality.
Read the detailed description
While physiological changes occur at the level of cells, tissues and systems with aging, these changes are reflected in motor and cognitive functions. The decrease in motor functions can be cause as balance and fall problems, which are the most serious and frequently encountered problems among the elderly. Especially the fall is one of the main reasons causing the elderly to be hospitalized in the hospital and nursing home.
Balance system is one of the most affected by aging process. The balance is maintained by receiving input from several systems, for this reason it is the system that is easily and primarily affected by changes in any of these inputs. Balance disorders have been shown to be risk factor for falling in elderly. Studies have shown that balance training has been observed to improve postural control, so it is especially recommended for to reduce risk and rate of falls in the elderly.
While general cognitive capacity decreases with aging, information processing, use and recall performance is lower than younger. Therefore, elderly have difficulty in tasks that require the use of more than one information at same time.
In daily life, a motor function is often accompanied by another task. Dual task performance is a secondary motor or cognitive task that must be implemented during a main task. Therefore, ın order for the exercises to be functional, it is not enough to be focused only on motor skills, besides adding a motor or cognitive dual task is more effective than exercise alone.
The changes in neuromusculoskeletal and movement-related functions during the aging process causes a decrease in functional ability. Most daily activities require the management of motor-cognitive tasks while simultaneously processing external information. The ability to perform in daily life activities decline in elderly.
Investigators hypothesized that balance exercises with dual task would show greater significant improvements functionality and cognitive improvements than the balance exercises only.
- Conditions
- Balance, Cognitive Functions, Dual Task, Functionality, Geriatrics
- Being tested
- Dual task exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task exercisesOther
Also called balance exercise group
Dual tasks, often also referred to as secondary tasks, present an objective-direct measurement in which two tasks are to be performed simultaneously to observe performance drops in either task.
| Study group | Role | What they receive |
|---|---|---|
| balance exercise group | Active comparator | The balance program was performed on soft and hard surface. Firstly the participants started the exercises on hard ground while standing. Postural balance program consisted of static and dynamic functional balance exercises (hıp flexion, hıp abduciton, semitandem stance, one leg stance, toe tips lifting). Afterwards exercises were performed on soft surface. Three sets of eight to ten repetitions of each exercise in a slow, controlled manner were performed. This section was completed 30 minitues. Receives: Other: Dual task exercises |
| Dual task exercises | Experimental | Dual task exercises are in two forms as motor dual task and cognitive dual task. In this study we used cognitive secondary task exercises. In addition to the exercises applied by the balance exercise group, a cognitive task was added. Participants in this group tried to count 4, 5 and 7 back from 100 while practicing balance exercises.
The balance program was performed on soft and hard surface. Firstly the participants started the exercises on hard ground while standing. Postural balance program consisted of static and dynamic functional balance exercises (hıp flexion, hıp abduciton, semitandem stance, one leg stance, toe tips lifting). Afterwards exercises were performed on soft surface. Three sets of eight to ten repetitions of each exercise in a slow, controlled manner were performed. This section was completed 30 minitues. Receives: Other: Dual task exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mini-Mental Status Examination (MMSE)
Cognitive Functioning Test
Measured: 7 minutes
The Functional Independence Measure (FIM)
Functionality Test
Measured: 10 minutes
Secondary outcomes (6)
The Berg Balance Scale (BBS)
Balance Test
Measured: 5 minutes
The "Timed Up and Go" test (TUG)
Physical function test
Measured: 3 minutes
Timed sit to stand test (TSST)
Physical function test
Measured: 2 minutes
Ten meters walk test (TMTWT)
Physical function test
Measured: 3 minutes
Tinetti Performance Oriented Mobility Assessment(POMA)
task-oriented test that measures an older adult's gait and balance abilities.
Measured: 15 minutes
The Montreal Cognitive Assessment (MoCA)
Cognitive Function Assesment
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Jun 2016
- Primary completion28 Sep 2016
- Study completion28 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Poyraz İşleyen, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333172
- Sponsor's protocol ID
- 10840098-604.01.01-E.7685
- Acronym
- geriatric
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Balance Training With Dual Task On Cognitive Status And Functionality In Elderly
- ClinicalTrials.gov ID
- NCT05333172
- Acronym / sponsor ID
- geriatric / 10840098-604.01.01-E.7685
- Conditions
- Balance, Cognitive Functions, Dual Task, Functionality, Geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Oct 2016 (actual)
- First posted
- 18 Apr 2022 (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.
Aging is a dynamic process that affects motor and cognitive functions. Activities of daily living and functionality, including dual task performance, are also negatively affected by these functions. The purpose of this study is to determine of balance training with dual task on cognitive function and functionality.
Detailed description
While physiological changes occur at the level of cells, tissues and systems with aging, these changes are reflected in motor and cognitive functions. The decrease in motor functions can be cause as balance and fall problems, which are the most serious and frequently encountered problems among the elderly. Especially the fall is one of the main reasons causing the elderly to be hospitalized in the hospital and nursing home.
Balance system is one of the most affected by aging process. The balance is maintained by receiving input from several systems, for this reason it is the system that is easily and primarily affected by changes in any of these inputs. Balance disorders have been shown to be risk factor for falling in elderly. Studies have shown that balance training has been observed to improve postural control, so it is especially recommended for to reduce risk and rate of falls in the elderly.
While general cognitive capacity decreases with aging, information processing, use and recall performance is lower than younger. Therefore, elderly have difficulty in tasks that require the use of more than one information at same time.
In daily life, a motor function is often accompanied by another task. Dual task performance is a secondary motor or cognitive task that must be implemented during a main task. Therefore, ın order for the exercises to be functional, it is not enough to be focused only on motor skills, besides adding a motor or cognitive dual task is more effective than exercise alone.
The changes in neuromusculoskeletal and movement-related functions during the aging process causes a decrease in functional ability. Most daily activities require the management of motor-cognitive tasks while simultaneously processing external information. The ability to perform in daily life activities decline in elderly.
Investigators hypothesized that balance exercises with dual task would show greater significant improvements functionality and cognitive improvements than the balance exercises only.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| balance exercise group | Active comparator | Other: Dual task exercisesThe balance program was performed on soft and hard surface. Firstly the participants started the exercises on hard ground while standing. Postural balance program consisted of static and dynamic functional balance exercises (hıp flexion, hıp abduciton, semitandem stance, one leg stance, toe tips lifting). Afterwards exercises were performed on soft surface. Three sets of eight to ten repetitions of each exercise in a slow, controlled manner were performed. This section was completed 30 minitues. |
| Dual task exercises | Experimental | Other: Dual task exercisesDual task exercises are in two forms as motor dual task and cognitive dual task. In this study we used cognitive secondary task exercises. In addition to the exercises applied by the balance exercise group, a cognitive task was added. Participants in this group tried to count 4, 5 and 7 back from 100 while practicing balance exercises. The balance program was performed on soft and hard surface. Firstly the participants started the exercises on hard ground while standing. Postural balance program consisted of static and dynamic functional balance exercises (hıp flexion, hıp abduciton, semitandem stance, one leg stance, toe tips lifting). Afterwards exercises were performed on soft surface. Three sets of eight to ten repetitions of each exercise in a slow, controlled manner were performed. This section was completed 30 minitues. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 65-85
- Being able to communicate
- Able to walk without mobility aids
- Be volunteer for intervention
Key exclusion criteria (4 listed)
- Cognitive impairment (<17 point on the Minimal Mental State Examination )
- In physiotherapy treatment that trains balance
- Balance impairment (< 20 point on the berg balance test)
- having an orthopedic problem that may affect balance performance
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 |
|---|---|---|
| Dual task exercisesAlso: balance exercise groupDual tasks, often also referred to as secondary tasks, present an objective-direct measurement in which two tasks are to be performed simultaneously to observe performance drops in either task. | Other | Dual task exercises, balance exercise group |
Primary outcome
The Mini-Mental Status Examination (MMSE)
Time frame: 7 minutes
Cognitive Functioning Test
The Functional Independence Measure (FIM)
Time frame: 10 minutes
Functionality Test
6 secondary outcomes
The Berg Balance Scale (BBS)
Time frame: 5 minutes
The "Timed Up and Go" test (TUG)
Time frame: 3 minutes
Timed sit to stand test (TSST)
Time frame: 2 minutes
Ten meters walk test (TMTWT)
Time frame: 3 minutes
Tinetti Performance Oriented Mobility Assessment(POMA)
Time frame: 15 minutes
The Montreal Cognitive Assessment (MoCA)
Time frame: 10 minutes
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 22 Apr 2022.
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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 Dual task exercises in people with Balance and Cognitive Functions, run by Bahçeşehir 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 4 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 22 Apr 2022. 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?
The Mini-Mental Status Examination (MMSE) (time frame: 7 minutes). The study lists 2 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 22 Apr 2022.