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Completed

NCT Number: NCT07257315

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

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.

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Key information

Conditions

Accidental Falls Behavior Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health centre "La palomera"

León, Castille and León, 24007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Otago Exercise Program - Supervised Group

Behavioral

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.

Otago Exercise Program - Home-Based

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sanidad de Castilla y León

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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