NCT07525453

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Mar 2026May 2026

Study Start

First participant enrolled

March 16, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 6, 2026

Last Update Submit

April 12, 2026

Conditions

Keywords

Dynamic BalanceOlder AdultsPostural ControlReaction Time

Outcome Measures

Primary Outcomes (1)

  • Dynamic Balance (Y Balance Test)

    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 Outcomes (5)

  • Functional Reach Distance

    From enrollment to the end of treatment at 8 weeks

  • 360-Degree Turn Time

    From enrollment to the end of treatment at 8 weeks

  • Reaction Time

    From enrollment to the end of treatment at 8 weeks

  • Fear of Falling (FES-I)

    From enrollment to the end of treatment at 8 weeks

  • Quality of Life (WHOQOL-BREF)

    From enrollment to the end of treatment at 8 weeks

Study Arms (3)

Core Stabilization Exercise Group

EXPERIMENTAL

Participants in this group will perform a structured core stabilization exercise program focusing on trunk muscle activation and postural control.

Behavioral: Core Stabilization Exercises

Amplitude-Based Exercise Group (LSVT BIG)

EXPERIMENTAL

Participants in this group will perform an amplitude-based exercise program derived from LSVT BIG principles, focusing on increasing movement amplitude and functional mobility.

Behavioral: Amplitude-Based Exercise (LSVT BIG)

Combined Core and Amplitude-Based Exercise Group

EXPERIMENTAL

Participants in this group will perform a combined exercise program including both core stabilization exercises and amplitude-based exercises based on LSVT BIG principles.

Behavioral: Combined Core and Amplitude-Based Exercise

Interventions

A structured exercise program focusing on trunk muscle activation, spinal stability, and postural control.

Core Stabilization Exercise Group

An exercise program derived from LSVT BIG principles, emphasizing increased movement amplitude and functional mobility.

Amplitude-Based Exercise Group (LSVT BIG)

A combined program including core stabilization exercises and amplitude-based exercises based on LSVT BIG principles.

Combined Core and Amplitude-Based Exercise Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atasehir 30 August Retirees Cultural Center, Istanbul, Turkey

Istanbul, Ataşehir, 34734, Turkey (Türkiye)

RECRUITING

Study Officials

  • Burcu AKKURT, PhD

    Fenerbahçe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

May 11, 2026

Study Completion (Estimated)

May 11, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations