- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06383676
Effect Of Functional Balance Exercise İn Elderly (RCT)
The Effect Of Functional Balance-Based Reaction Exercises On Improvement Of Physical Capacity And Cognitive Performance In Elderly Individual
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 06000
- Fatma kübra çekok
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of 65 or above
- Minimum of 5 years of education
- Moca score of 21 or higher
- Capability to walk a minimum of 10 meters (with or without walking assistance if needed)
Exclusion Criteria:
- Moca test score 21 and below
- Having vision and hearing problems (which cannot be corrected with glasses or hearing aids)
- Having an orthopedic or neurological disease that prevents standing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Functional balance based reaction exercise training.
Functional balance-based balance reaction exercises will be integrated into functional balance exercises with the help of the BlazePod™ training device panel.
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The interventions will carried out two days a week and 40 minutes, for eight weeks.
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Experimental: Functional balance training
The exercises will consist of functional balance activities, such as maintaining a standing posture, transitioning from sitting to standing, walking and balancing on one leg.
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The interventions will carried out two days a week and 40 minutes, for eight weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Montreal Cognitive Assessment (MoCA)
Time Frame: Eight weeks
|
The Montreal Cognitive Assessment (MoCA) is a brief instrument developed for the screening of milder forms of cognitive impairment.
A score is derived by summing the points from each successfully completed task, for a total range from 0 to 30 points; higher scores indicate better cognitive performance.
The MoCA was developed to screen milder forms of cognitive impairment through the assessment of a wide range of cognitive functions, such as short-term memory, executive functions, visuospatial abilities, language, attention, concentration, working memory, and temporal and spatial orientation.
It comprises a 1-page test, which requires a short administration time (10-15 minutes).
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Eight weeks
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Stroop Test
Time Frame: Eight weeks
|
The test consists of two cards, each containing 60 items, presented in six rows of 10 items. On the first card, there are small rectangles (0.5 x 1 cm) printed in red, green and blue. The second card contains names of the three colours (i.e., red, green and blue) printed in incongruent colours (e.g., the word 'red' is printed in blue ink). The Stroop test Çapa version consists of three parts: Stroop A, Stroop B and Stroop C. Stroop A. The first part of the test requires individuals to name the colours (i.e., red, green and blue) of the small rectangles as quickly as possible, following a sequence from left to right. If any sign of colour blindness or colour naming deficits is present, the test is discontinued. Stroop B. The second part of the test requires individuals to read as fast as possible the colour names (i.e., red, green, and blue) that are printed in incongruent ink colours. The Stroop test Çapa version consists of three parts: Stroop A, Stroop B and Stroop C. Stroop A. The |
Eight weeks
|
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The Simple Reaction Time
Time Frame: Eight weeks
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The simple reaction time is measured using an electronic timing system (including a digital display, a light, and a button, and the protocol that has been described in the literature was followed .
Each older is seated so that the resting arm was on the table in a quiet environment.
The testing side's second index is placed 1 cm away from the button of the device.
Then, the participants are asked to press the button when the visual or auditory input appeared.
A total of 10 repetitions are recorded, and the mean score of the last 5 tests is further analyzed .. The visual and auditory reaction time is randomly assigned.
The reaction time is recorded with 1/1,000 seconds of sensitivity.
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Eight weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Four Square Step Test (FSST)
Time Frame: Eight weeks
|
The Four Square Step Test (FSST) has been widely used for evaluating dynamic balance in older populations.
The FSST requires a stopwatch and four single-point sticks (SPS).
Using the sticks resting flat on the floor to form a cross, the subject starts in one square, steps in one direction into each of the four squares, and then reverses direction back to the start.
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Eight weeks
|
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The short physical performance battery (SPPB)
Time Frame: Eight weeks
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The short physical performance battery (SPPB) is a quick and useful tool for fall risk stratification among older primary care patients.
The SPPB, a 3-part performance-based test (gait time, chair stand, and balance), was assessed at baseline.
Each test is scored from 0 (inability to perform the task) to 4 points (best test performance) .
The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three or four classes of scores: three classes: 0-6 points (poor performance),
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Eight weeks
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Timed Up and Go Test (TUG)
Time Frame: Eight weeks
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Timed Up and Go Test (TUG) has been recommended as a simple fall risk screening tool, primarily to identify people warranting more-detailed assessment of gait and balance.
Measures the time taken (in seconds) for a person to rise from a chair with armrests, walk 3 meters with usual assistive devices, turn, return to the chair, and sit down
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Eight weeks
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Falls Efficacy Scale ( FES)
Time Frame: Eight weeks
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Falls Efficacy Scale is widely used 16-item Falls Efficacy Scale (FES) evaluate the social dimension of fear of falling and refers almost exclusively to very basic activities of daily living, making it insensitive when used in active older persons.
Each item is scored on a four-point scale: 1 = not at all concerned, 2 = somewhat concerned, 3 = fairly concerned and 4 = very concerned.
A summary score is calculated by adding the score of each item, giving a scale ranging from 16 to 64 for the 16-item FES-I and from 7 to 28 for the seven-item FES-I.
A low score indicates low fear of falling
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Eight weeks
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Mini-BESTest: Balance Evaluation Systems Test
Time Frame: Eight weeks
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The Balance Evaluation Systems Test (BESTest) is a relatively new multi-task balance assessment developed to identify specific postural control problems (i.e., biomechanical constraints, stability limits, postural responses, anticipatory postural adjustments, sensory orientation, dynamic balance during gait, and cognitive effect).
The Mini-BESTest is a 14-item performance-based measure of balance disorders.The total score ranged from 0 to 28, with higher scores denoting better balance ability.
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Eight weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma Kübra ÇEKOK, Phd, Tarsus University
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
Keywords
Other Study ID Numbers
- 1 (Other Identifier: Mobile Health and Wellness Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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