NCT07739173

Brief Summary

To compare the short-term effects and 6-month durability of supervised multicomponent exercise, balance exercise alone, and fall-prevention education on balance, strength, walking performance, and health-related quality of life in older adults with recurrent falls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

accidental fallsagedexercise therapypostural balancequality of life

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale (BBS)

    A 14-item performance measure scored from 0 to 56; higher scores indicate better balance.

    Baseline, 8 weeks, and 6 months

Secondary Outcomes (3)

  • Handgrip strength

    Baseline, 8 weeks, and 6 months.

  • 10-m walk time

    Baseline, 8 weeks, and 6 months.

  • Short Form-36 (SF-36)

    Baseline, 8 weeks, and 6 months.

Study Arms (3)

Multicomponent exercise

EXPERIMENTAL

Supervised balance-coordination exercises followed by elastic-band strengthening of the quadriceps, hamstrings, hip abductors, and hip adductors, plus mini-squats. Sessions were delivered 3 days per week for 8 weeks.

Behavioral: Multicomponent exercise

Balance exercise

ACTIVE COMPARATOR

Supervised balance-coordination tasks, warm-up, and stretching only, without resistance exercises or mini-squats. Sessions were delivered 3 days per week for 8 weeks.

Behavioral: Balance exercise

Control

NO INTERVENTION

Standardized education on reducing fall risk only, without any supervised exercise program.

Interventions

Supervised balance-coordination exercises and lower-extremity strengthening using elastic bands (quadriceps, hamstrings, hip abductors, hip adductors) and mini-squats.

Multicomponent exercise

Supervised balance-coordination tasks, warm-up, and stretching

Balance exercise

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or older,
  • more than two falls during the preceding year,
  • unimpaired Timed Up and Go performance,
  • Beck Depression Inventory score consistent with safe participation

You may not qualify if:

  • Contraindication to exercise,
  • fracture,
  • cancer,
  • active joint disease or infection,
  • pulmonary disease,
  • uncontrolled diabetes mellitus or hypertension,
  • congestive heart failure, or
  • serious neurological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University Faculty of Medicine Hospital

Balıkesir, Balıkesir, 10135, Turkey (Türkiye)

Location

Study Officials

  • Nilay Şahin, MD, Prof.

    Balikesir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

November 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations