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

NCT ID: NCT07257315

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-02

Study Completion Date

2025-11-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Accidental Falls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Otago Exercise Program - Supervised Group

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Otago Exercise Program - Home-Based

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanidad de Castilla y León

OTHER

Sponsor Role lead

Responsible Party

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Jose Angel Delgado Gil

Physical therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Angel Delgado-Gil, PT (Physiotherapist)

Role: PRINCIPAL_INVESTIGATOR

Sanidad de Castilla y León

Locations

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Health centre "La palomera"

León, Castille and León, Spain

Site Status

Countries

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Spain

Other Identifiers

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2395

Identifier Type: -

Identifier Source: org_study_id

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