Viewing Study NCT07024004


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Ignite Modification Date: 2025-12-27 @ 8:15 AM
Study NCT ID: NCT07024004
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-06-17
First Post: 2025-04-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Active Exergames Program in Older Adults at Risk of Falls
Sponsor: Universidad Catolica Silva Henriquez
Organization:

Study Overview

Official Title: Effects of Active Exergames Program on Muscle Strength, Lower Limb Muscle Mass and Physical Fitness in Older Adults at Risk of Falls
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2025-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: