- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525453
Effects of Three Different Exercise Programs on Dynamic Balance in Community-Dwelling Older Adults
Effects of Three Different Exercise Programs on Dynamic Balance in Community-Dwelling Older Adults: A Randomized Controlled Trial
This study aims to compare the effects of core stabilization exercises, an amplitude-based exercise program derived from LSVT BIG principles, and their combination on dynamic balance in community-dwelling healthy older adults aged 65 years and above. Secondary outcomes include functional mobility, fear of falling, reaction time, and quality of life.
Age-related declines in neuromuscular and sensory functions impair postural control and increase fall risk. While both core stabilization and amplitude-based exercises have shown beneficial effects, their comparative and combined effects in healthy older adults remain unclear. This study will determine whether the combined intervention provides additional benefits over single interventions.
Study Overview
Status
Conditions
Detailed Description
Aging is associated with progressive declines in muscle strength, proprioceptive function, vestibular efficiency, and reaction time, all of which contribute to impaired postural control and reduced dynamic balance. These changes significantly increase the risk of falls in older adults, representing a major public health concern due to their association with morbidity, mortality, and loss of independence.
Exercise-based interventions are widely recommended to improve balance and reduce fall risk. Core stabilization exercises aim to enhance trunk muscle activation and improve postural control by increasing spinal stability. In contrast, amplitude-based exercise approaches derived from LSVT BIG principles focus on increasing movement amplitude, thereby improving motor performance and functional mobility. Although both approaches have demonstrated beneficial effects, evidence regarding their comparative effectiveness and the potential additive benefit of combining these interventions in healthy older adults remains limited.
In this randomized controlled study, participants aged 65 years and older will be allocated to one of three intervention groups: core stabilization exercises, amplitude-based exercises based on LSVT BIG principles, or a combined core and amplitude-based exercise program. All interventions will be conducted over a structured training period under supervision.
Dynamic balance will be assessed as the primary outcome. Secondary outcomes will include functional mobility, fear of falling, reaction time, and quality of life. Standardized and validated assessment tools will be used to ensure reliability of the measurements.
The findings of this study are expected to provide evidence on the relative and combined effectiveness of these exercise approaches and may contribute to the development of more effective rehabilitation strategies aimed at improving balance and reducing fall risk in older adults.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Burcu AKKURT, PhD
- Phone Number: 0 216 910 1907
- Email: burcu.akkurt@fbu.edu.tr
Study Locations
-
-
Ataşehir
-
Istanbul, Ataşehir, Turkey (Türkiye), 34734
- Recruiting
- Atasehir 30 August Retirees Cultural Center, Istanbul, Turkey
-
Contact:
- Burcu AKKURT
- Phone Number: 05536046713
- Email: burcu.akkurt@fbu.edu.tr
-
Contact:
- Elif Düşgün, Phd
- Phone Number: 0 216 910 1907
- Email: elif.dusgun@fbu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 65 years and older
- Ability to walk independently
- Mini-Mental State Examination (MMSE) score > 24, indicating sufficient cognitive ability to understand and follow instructions
- Willingness to participate in the study and provide written informed consent
Exclusion Criteria:
- History of serious lower extremity injury, surgery, or acute musculoskeletal condition within the last 6 months
- Severe visual or hearing impairment that would prevent safe and accurate completion of the assessments
- Presence of acute vestibular disorders significantly affecting balance
- Presence of neurological disease
- Uncontrolled cardiac disease, uncontrolled hypertension, severe pulmonary disease, or any condition that makes exercise unsafe
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core Stabilization Exercise Group
Participants in this group will perform a structured core stabilization exercise program focusing on trunk muscle activation and postural control.
|
A structured exercise program focusing on trunk muscle activation, spinal stability, and postural control.
|
|
Experimental: Amplitude-Based Exercise Group (LSVT BIG)
Participants in this group will perform an amplitude-based exercise program derived from LSVT BIG principles, focusing on increasing movement amplitude and functional mobility.
|
An exercise program derived from LSVT BIG principles, emphasizing increased movement amplitude and functional mobility.
|
|
Experimental: Combined Core and Amplitude-Based Exercise Group
Participants in this group will perform a combined exercise program including both core stabilization exercises and amplitude-based exercises based on LSVT BIG principles.
|
A combined program including core stabilization exercises and amplitude-based exercises based on LSVT BIG principles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Balance (Y Balance Test)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The Y Balance Test is a reliable and valid measure used to assess dynamic balance and neuromuscular control. It is a modified version of the Star Excursion Balance Test and evaluates an individual's ability to maintain single-leg stance while reaching in multiple directions. During the test, the participant stands on one leg at the center of a Y-shaped grid and uses the free limb to reach as far as possible in three directions: anterior, posteromedial, and posterolateral. Reach distances are measured in centimeters, and a composite score is calculated by normalizing reach distances to limb length. Higher reach distances and composite scores indicate better dynamic balance performance. The test has been widely used in clinical and research settings due to its sensitivity in detecting balance deficits and risk of injury or falls. |
From enrollment to the end of treatment at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Reach Distance
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Dynamic balance will be assessed using the Functional Reach Test.
Participants will reach forward as far as possible while maintaining a fixed base of support, and the distance reached will be recorded in centimeters.
|
From enrollment to the end of treatment at 8 weeks
|
|
360-Degree Turn Time
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Dynamic balance will be evaluated by measuring the time required to complete a full 360-degree turn in a standing position.
Shorter times indicate better performance.
|
From enrollment to the end of treatment at 8 weeks
|
|
Reaction Time
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Reaction time will be measured using a computerized system by recording responses to visual and auditory stimuli.
Mean reaction time values will be used for analysis.
|
From enrollment to the end of treatment at 8 weeks
|
|
Fear of Falling (FES-I)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Fear of falling will be assessed using the Falls Efficacy Scale International (FES-I), a validated self-reported questionnaire.
|
From enrollment to the end of treatment at 8 weeks
|
|
Quality of Life (WHOQOL-BREF)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Quality of life will be evaluated using the WHOQOL-BREF questionnaire, which assesses physical, psychological, social, and environmental domains.
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Burcu AKKURT, PhD, Fenerbahce University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 15.2026fbu
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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