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

NCT07257315 | Completed DMC

• 1 other identifier: 2395
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Accidental Falls

Keywords

Accidental Falls; Risk Factors; Postural Balance; Muscle Strength; Resistance Training Gait; Exercise

Outcome Measures

Primary Outcomes (2)

• Timed Up and Go (TUG)

  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

  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)

Study Arms (2)

Supervised Group Otago Exercise Program

EXPERIMENTAL

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

Home-Based Otago Exercise Program

ACTIVE COMPARATOR

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

Interventions

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.

Supervised Group Otago Exercise Program

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.

Home-Based Otago Exercise Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanidad de Castilla y León: lead

Study Sites (1)

Health centre "La palomera"

León, Castille and León, 24007, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jose Angel Delgado-Gil, PT (Physiotherapist)

  Sanidad de Castilla y León

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Outcome assessors are blinded to group assignment. Participants and intervention supervisors are aware of the assigned intervention, but the evaluators measuring functional outcomes, including the Timed Up and Go test and gait speed, do not know which group participants belong to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Model Details: Participants are randomly assigned to one of two parallel groups. The experimental group performs the Otago Exercise Program in supervised group sessions led by a physiotherapist, while the control group performs the same program independently at home. Each participant remains in their assigned group for the entire duration of the intervention.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: February 2, 2023
• Primary Completion: October 2, 2025
• Study Completion: November 3, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)