Active Exergames Program in Older Adults at Risk of Falls

Not Applicable

Active, not recruiting

• Conditions: Risk of Falls

• Registration Number: NCT07024004
• Lead Sponsor: Universidad Catolica Silva Henriquez

Brief Summary

The goal of this randomized clinical trial is to analyze the effectiveness of a physical exercise program based on exergames combined with conventional physical therapy, compared to a conventional physical exercise program alone, in improving lower limb strength, muscle quality, and physical capacity in older adults at risk of falling. The main questions it aims to answer are:

Does a combined exergame and conventional exercise program improve functional capacity in older adults at risk of falling more than traditional exercise alone? Does the intervention improve lower limb strength and muscle quality more effectively than conventional exercise alone?

Researchers will compare a group receiving exergame-based exercise combined with conventional therapy to a group receiving conventional physical exercise only to see if the addition of exergames enhances functional outcomes and muscle performance.

Participants will:

* Undergo baseline and post-intervention assessments of lower limb strength, muscle quality, and physical capacity.

* Participate in a structured physical exercise program.

* In the intervention group, perform exergame-based exercises using virtual reality gaming systems such as Nintendo Switch (Ring Fit Adventure).

* Engage in sessions for several weeks, with consistent frequency and intensity depending on the group allocation.

Detailed Description

Falls in older adults have been associated with a decrease in physical activity, the level of functionality and an increase in dependency. Furthermore, falls and their consequences are one of the main causes of mortality among older people. Falls are more frequent in women, in people over 75 years of age and with sensory deficits.

Currently, there are promising and novel solutions to prevent and/or avoid the repetition of falls; Among them, the use of active exergames stands out. Active exergames can be developed in health, community, sports centers or in a homeroom individually or in groups using a screen through video games that involve the movement of the whole body, like the real world with or without the use of a controller that allows you to execute movements in a small space and interact with the game scenario. They have been shown to be useful for improving balance and physical condition in people of different ages and health conditions, but there is little evidence of studies that analyze the effects of this therapeutic strategy in older adults at risk of falling.

Active exergames are a novel, simple, motivating, and easy-to-implement treatment option to promote healthy aging and prevent the risk of falls in older people. Therefore, it has the potential to become, in the short term, a therapeutic strategy for mass use, with high adherence and low cost in health centers.

Exergames have an affordable cost, with a wide variety of games and are easy to use, therefore it is increasingly accepted by different types of patients as a therapeutic strategy.

The evidence indicates that, both programs are expected to improve the primary and secondary outcomes proposed in this project. Additionally, older adults who execute an active exergame program are expected to have better performance compared to a conventional physiotherapy program in the main outcome and the secondary outcomes analyzed. It is expected to promote the use of active exergames by rehabilitation professionals in primary health care centers to prevent falls in older adults.

Study Timeline

• Study Start: 2025-04-01
• Study First Submitted: 2025-04-05
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-14
• Last Update Submitted: 2025-06-14
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Adults aged 60 years or older
• Both sexes eligible
• Attendees of SENAMA day centers (senior care centers) in the Metropolitan Region of Santiago, Chile.
• Mini-Mental State Examination (MMSE) score > 14
• Barthel Index score > 60 (indicating moderate to good functional independence)
• No self-reported medical contraindications for physical exercise
• Ability to walk independently (with or without assistive devices)
• Provided written informed consent

Exclusion Criteria

• Recent bone fractures or acute myocardial infarction
• Severe cardiovascular or respiratory conditions
• Uncontrolled hypertension or diabetes mellitus
• Cognitive or sensory impairments that limit instruction comprehension
• Participation in other exercise programs during the study period
• Inability to attend at least 80% of the intervention sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Risk of fall	Baseline and 12 weeks post-intervention	Fall risk will be evaluated using the Downton Fall Risk Index (DFRI), a 5-item composite score based on prior falls, medication, sensory deficits, mental state, and mobility. A total score \>3 indicates high fall risk.
Functional Independence	Baseline and 12 weeks post-intervention	Functional independence will be measured with FIM scale, it consists of 18 items that assess both motor and cognitive skills, and is scored on a 7-level scale, where 1 indicates total dependence and 7 complete independence.
Center of Pressure (COP)	Baseline and 12 weeks post-intervention	Posturography, which records center of pressure displacement while standing on a stable platform.
Aerobic capacity	Baseline and 12 weeks post-intervention	Aerobic capacity is assessed by the 2-Minute Walk Test, which measures the total distance (in meters) covered at a self-selected walking pace within 2 minutes on a flat surface.
Static balance	Baseline and 12 weeks post-intervention	Single-Leg Stance Test (Unipedal Stance Test), where participants must maintain balance on one leg for at least 5 seconds.
Dynamic balance	Baseline and 12 weeks post-intervention	Dynamic balance is measured with the Timed Up and Go (TUG) test, which evaluates the time in seconds that a participant takes to rise from a chair, walk 3 meters, turn, return, and sit down again.

Secondary Outcome Measures

Name	Time	Method
body composition	Baseline and 12 weeks post-intervention	Segmental muscle mass of the lower limbs will be assessed using a bioelectrical impedance analyzer (InBody 270). The participant stands barefoot and holds electrodes as the device estimates muscle mass.
Handgrip strength	Baseline and 12 weeks post-intervention	handgrip strength will be assessed bilaterally in a seated position using a handheld dynamometer with the elbow at 90° flexion. The highest value from three attempts will be recorded (in kilograms).
Lower Limb Muscle Strength	Baseline and 12 weeks post-intervention	Strength of the lower limbs will be evaluated using the Five Times Sit-to-Stand Test (FTSST). Participants are asked to sit and stand from a chair five times as quickly as possible, with arms crossed over the chest. The time taken (in seconds) will be recorded.
Intramuscular Fat Infiltration	Baseline and 12 weeks post-intervention	Muscle echogenicity will be measured via ultrasound (transversal view of the quadriceps). Images will be analyzed using ImageJ software to calculate grayscale intensity (0-255 arbitrary units), which reflects intramuscular fat content.
Muscle Architecture	Baseline and 12 weeks post-intervention	Muscle architecture (muscle thickness, pennation angle, fascicle length) of the quadriceps will be evaluated through ultrasound imaging. These anatomical variables will be analyzed using ImageJ software.

Trial Locations

Locations (1)

Universidad Católica Silva Henríquez; 🇨🇱 Santiago, Región Metropolitana, Chile