- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05333172
The Effect Of Balance Training With Dual Task On Cognitive Status And Functionality In Elderly (geriatric)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Tuğçe Poyraz Isleyen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being between the ages of 65-85
- Being able to communicate
- Able to walk without mobility aids
- Be volunteer for intervention
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: balance exercise group
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.
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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.
Other Names:
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Experimental: Dual task exercises
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. |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Mini-Mental Status Examination (MMSE)
Time Frame: 7 minutes
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Cognitive Functioning Test
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7 minutes
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The Functional Independence Measure (FIM)
Time Frame: 10 minutes
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Functionality Test
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Berg Balance Scale (BBS)
Time Frame: 5 minutes
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Balance Test
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5 minutes
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The "Timed Up and Go" test (TUG)
Time Frame: 3 minutes
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Physical function test
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3 minutes
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Timed sit to stand test (TSST)
Time Frame: 2 minutes
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Physical function test
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2 minutes
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Ten meters walk test (TMTWT)
Time Frame: 3 minutes
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Physical function test
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3 minutes
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Tinetti Performance Oriented Mobility Assessment(POMA)
Time Frame: 15 minutes
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task-oriented test that measures an older adult's gait and balance abilities.
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15 minutes
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The Montreal Cognitive Assessment (MoCA)
Time Frame: 10 minutes
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Cognitive Function Assesment
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10 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10840098-604.01.01-E.7685
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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