Effect Of Functional Balance Exercise İn Elderly (RCT)

December 23, 2024 updated by: Fatma Kübra ÇEKOK, Tarsus University

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06000
        • Fatma kübra çekok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
The interventions will carried out two days a week and 40 minutes, for eight weeks.
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.
The interventions will carried out two days a week and 40 minutes, for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Eight weeks
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
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.
Eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Eight weeks
The short physical performance battery (SPPB)
Time Frame: Eight weeks
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),
Eight weeks
Timed Up and Go Test (TUG)
Time Frame: Eight weeks
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
Eight weeks
Falls Efficacy Scale ( FES)
Time Frame: Eight weeks
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
Eight weeks
Mini-BESTest: Balance Evaluation Systems Test
Time Frame: Eight weeks
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.
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fatma Kübra ÇEKOK, Phd, Tarsus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

April 21, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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