Effectiveness of a Program to Improve Balance, Mobility, and Fall Prevention in Older Adults.

November 20, 2025 updated by: Jose Angel Delgado Gil, Sanidad de Castilla y León

Effectiveness of a Program to Improve Balance, Mobility, and Fall Prevention in Older Adults: A Randomized Clinical Trial.

This trial evaluates the effectiveness of the Otago Exercise Program in adults aged 65 and older. It compares supervised group-based training with an unsupervised home-based version of the same program. The primary aim is to assess changes in Timed Up and Go performance and gait speed before and after the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study investigates the effectiveness of the Otago Exercise Program (OEP) as a fall-prevention intervention in adults aged 65 years and older. The OEP is a structured, evidence-based program that includes strength, balance, and functional training exercises designed to reduce fall risk in older adults.

Participants will be randomly assigned to one of two groups. The experimental group will complete the Otago program in supervised group sessions led by a physiotherapist. The control group will perform the same Otago exercises individually at home without supervision, following standard instructions for independent implementation.

The primary objective of the study is to compare the effect of the supervised group-based program versus the unsupervised home-based program on functional mobility and gait performance. Primary outcomes include changes in the Timed Up and Go (TUG) test and gait speed measured before and after the intervention period.

This trial aims to determine whether supervised group training provides additional benefits over independent home-based execution of the Otago program in improving mobility and reducing fall risk among community-dwelling older adults.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Spain
    • Castille and León
      • León, Castille and León, Spain, 24007
        • Health centre "La palomera"

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

Yes

Description

Inclusion Criteria:

  • Adults aged 65 years or older.
  • Community-dwelling individuals able to ambulate independently (with or without assistive devices).
  • Ability to understand instructions and follow the exercise program.
  • Able to attend assessment sessions at baseline and post-intervention.

Exclusion Criteria:

  • Severe cognitive impairment that limits ability to follow instructions.
  • Medical conditions contraindicating exercise (e.g., unstable cardiac disease, uncontrolled hypertension).
  • Recent lower-limb fracture or surgery within the last 6 months.
  • Neurological conditions significantly affecting gait or balance (e.g., advanced Parkinson's disease, recent stroke).
  • Participation in another structured exercise or fall-prevention program during the study period.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised Group Otago Exercise Program
Participants perform the Otago Exercise Program in supervised group sessions led by a physiotherapist. The program includes structured strength, balance, and functional exercises designed to reduce fall risk. Sessions are conducted 2-3 times per week, and participants follow the program under professional guidance throughout the intervention period.
Behavioral: Otago Exercise Program - Supervised Group
Participants perform the Otago Exercise Program in supervised group sessions led by a physiotherapist. The program includes structured strength, balance, and functional exercises conducted 2-3 times per week throughout the intervention period.
Active Comparator: Home-Based Otago Exercise Program
Participants perform the same Otago Exercise Program independently at home, following standard written instructions. The program includes the same strength, balance, and functional exercises, performed 2-3 times per week, without direct supervision from a physiotherapist.
Behavioral: Otago Exercise Program - Home-Based
Participants perform the same Otago Exercise Program independently at home, following standard written instructions. Exercises include strength, balance, and functional components, performed 2-3 times per week without supervision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG)
Time Frame: Baseline and immediately after the intervention period (3 months)
Functional mobility is assessed using the Timed Up and Go test. Participants rise from a chair, walk 3 meters, turn, walk back, and sit down. The time to complete the task is recorded in seconds.
Baseline and immediately after the intervention period (3 months)
Gait Speed
Time Frame: Baseline and immediately after the intervention period (3 months)
Walking speed is measured over a standardized distance (6 meters). The participant walks at a comfortable pace, and the time to complete the distance is recorded to calculate gait speed in meters per second.
Baseline and immediately after the intervention period (3 months)

Collaborators and Investigators

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

Sponsor

Sanidad de Castilla y León

Investigators

  • Principal Investigator: Jose Angel Delgado-Gil, PT (Physiotherapist), Sanidad de Castilla y León

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)

February 2, 2023

Primary Completion (Actual)

October 2, 2025

Study Completion (Actual)

November 3, 2025

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study team does not plan to share individual participant data.

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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