Older PeopleNCT06383676
Effect Of Functional Balance Exercise İn Elderly
A study testing Functional reaction balance training and Functional balance training in people with Older People and Exercise, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
The elderly population is increasing in Turkey and in the world. Many health problems, such as a decrease in physical and psychological abilities and an increase in chronic problems, occur with aging. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Older People, Exercise
- What is being tested?
- Functional reaction balance training and Functional balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 30 Oct 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 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Functional Balance-Based Reaction Exercises On Improvement Of Physical Capacity And Cognitive Performance In Elderly Individual
The elderly population is increasing in Turkey and in the world. Many health problems, such as a decrease in physical and psychological abilities and an increase in chronic problems, occur with aging. It is important to encourage and support practices for the development of exercises to increase physical and cognitive capacity in order to early recognize and reduce the effects of problems that develop with aging. To the best of our knowledge, there is no exercise training to increase reaction time in the elderly in the literature.
Read the detailed description
The study was planned as a randomized controlled study. Volunteer participants over the age of 65 living in a nursing home in Ankara will be included in the study. The sample of the study will consist of 28 elderly individuals, as determined by power analysis. The participants will be randomly divided into two groups. One group (Group 1) will receive functional balance exercise training, and the other group (Group 2) will receive functional balance-based reaction exercise training. The participants socio-demographic information, cognitive level ( The Montreal Cognitive Assessment), executive function (Stroop Test), reaction time, physical performance (Four Step Square test, Short Physical Performance Battery, Time Up Go Test) and balance confidence (Falls Efficiency Scale) will be evaluated Evaluations will be repeated at baseline and 8 weeks later. The interventions will be carried out two days a week for 40 minutes for eight weeks.
- Conditions
- Older People, Exercise
- Being tested
- Functional reaction balance training, Functional balance training
- Keywords
- balance, reaction time, functional capacity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional reaction balance trainingOther
The interventions will carried out two days a week and 40 minutes, for eight weeks.
Functional balance trainingOther
The interventions will carried out two days a week and 40 minutes, for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Functional balance based reaction exercise training. | Experimental | Functional balance-based balance reaction exercises will be integrated into functional balance exercises with the help of the BlazePod™ training device panel. Receives: Other: Functional reaction balance training |
| Functional balance training | Experimental | 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. Receives: Other: Functional balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Montreal Cognitive Assessment (MoCA)
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).
Measured: Eight weeks
Stroop Test
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
Measured: Eight weeks
The Simple Reaction Time
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.
Measured: Eight weeks
Secondary outcomes (5)
The Four Square Step Test (FSST)
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.
Measured: Eight weeks
The short physical performance battery (SPPB)
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),
Measured: Eight weeks
Timed Up and Go Test (TUG)
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
Measured: Eight weeks
Falls Efficacy Scale ( FES)
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
Measured: Eight weeks
Mini-BESTest: Balance Evaluation Systems Test
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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start20 Apr 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as a randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kübra ÇEKOK, Tarsus University
- Investigators
- Fatma Kübra ÇEKOK, Phd, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383676
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2024
- First submitted
- 21 Apr 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Functional Balance-Based Reaction Exercises On Improvement Of Physical Capacity And Cognitive Performance In Elderly Individual
- ClinicalTrials.gov ID
- NCT06383676
- Acronym / sponsor ID
- 1
- Conditions
- Older People, Exercise
- Keywords
- balance, reaction time, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 25 Apr 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 elderly population is increasing in Turkey and in the world. Many health problems, such as a decrease in physical and psychological abilities and an increase in chronic problems, occur with aging. It is important to encourage and support practices for the development of exercises to increase physical and cognitive capacity in order to early recognize and reduce the effects of problems that develop with aging. To the best of our knowledge, there is no exercise training to increase reaction time in the elderly in the literature.
Detailed description
The study was planned as a randomized controlled study. Volunteer participants over the age of 65 living in a nursing home in Ankara will be included in the study. The sample of the study will consist of 28 elderly individuals, as determined by power analysis. The participants will be randomly divided into two groups. One group (Group 1) will receive functional balance exercise training, and the other group (Group 2) will receive functional balance-based reaction exercise training. The participants socio-demographic information, cognitive level ( The Montreal Cognitive Assessment), executive function (Stroop Test), reaction time, physical performance (Four Step Square test, Short Physical Performance Battery, Time Up Go Test) and balance confidence (Falls Efficiency Scale) will be evaluated Evaluations will be repeated at baseline and 8 weeks later. The interventions will be carried out two days a week for 40 minutes for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Functional balance based reaction exercise training. | Experimental | Other: Functional reaction balance trainingFunctional balance-based balance reaction exercises will be integrated into functional balance exercises with the help of the BlazePod™ training device panel. |
| Functional balance training | Experimental | Other: Functional balance trainingThe exercises will consist of functional balance activities, such as maintaining a standing posture, transitioning from sitting to standing, walking and balancing on one leg. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Functional reaction balance trainingThe interventions will carried out two days a week and 40 minutes, for eight weeks. | Other | Functional balance based reaction exercise training. |
| Functional balance trainingThe interventions will carried out two days a week and 40 minutes, for eight weeks. | Other | Functional balance training |
Primary outcome
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).
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
The Simple Reaction Time
Time frame: Eight weeks
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.
5 secondary outcomes
The Four Square Step Test (FSST)
Time frame: Eight weeks
The short physical performance battery (SPPB)
Time frame: Eight weeks
Timed Up and Go Test (TUG)
Time frame: Eight weeks
Falls Efficacy Scale ( FES)
Time frame: Eight weeks
Mini-BESTest: Balance Evaluation Systems Test
Time frame: Eight weeks
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Fatma Kübra ÇEKOK, Phd principal investigator
Tarsus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional reaction balance training and Functional balance training in people with Older People and Exercise, run by Tarsus 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 3 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 27 Dec 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?
The Montreal Cognitive Assessment (MoCA) (time frame: Eight weeks). The study lists 3 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 27 Dec 2024.