Clinical trial NCT07024004: Active Exergames Program in Older Adults at Risk of Falls
Official title: Effects of Active Exergames Program on Muscle Strength, Lower Limb Muscle Mass and Physical Fitness in Older Adults at Risk of Falls
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Risk of Falls
Keywords: Exergames
Virtual Reality Exercise
Older Adults
Fall Prevention
Lead sponsor: Universidad Catolica Silva Henriquez
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigacion y Desarrollo, ANID
First posted: 2025-06-17
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment:

This study uses a parallel assignment model, where participants are randomly assigned to one of two groups:

Group 1 receives a combined intervention of exergame-based exercise and conventional physical therapy.

Group 2 receives conventional physical therapy alone.

The interventions are conducted simultaneously over a 12-week period, 2 sessions per week of one hour each, and comparisons are made between and within groups to evaluate outcomes such as lower limb strength, muscle quality, and physical function.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk of fall
timeFrame: Baseline and 12 weeks post-intervention
measure: Functional Independence
timeFrame: Baseline and 12 weeks post-intervention
measure: Center of Pressure (COP)
timeFrame: Baseline and 12 weeks post-intervention
measure: Dynamic balance
timeFrame: Baseline and 12 weeks post-intervention
measure: Static balance
timeFrame: Baseline and 12 weeks post-intervention
measure: Aerobic capacity
timeFrame: Baseline and 12 weeks post-intervention
Secondary outcomes:
measure: body composition
timeFrame: Baseline and 12 weeks post-intervention
measure: Handgrip strength
timeFrame: Baseline and 12 weeks post-intervention
measure: Lower Limb Muscle Strength
timeFrame: Baseline and 12 weeks post-intervention
measure: Intramuscular Fat Infiltration
timeFrame: Baseline and 12 weeks post-intervention
measure: Muscle Architecture
timeFrame: Baseline and 12 weeks post-intervention
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad Católica Silva Henríquez
state: Región Metropolitana
Study officials:
affiliation: Universidad Católica Silva Henríquez
name: Paloma Lillo Urzúa, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deng N, Soh KG, Abdullah BB, Tan H, Huang D. Active video games for improving health-related physical fitness in older adults: a systematic review and meta-analysis. Front Public Health. 2024 Apr 17;12:1345244. doi: 10.3389/fpubh.2024.1345244. eCollection 2024.
citation: Hernandez-Martinez J, Ramos-Espinoza F, Munoz-Vasquez C, Guzman-Munoz E, Herrera-Valenzuela T, Branco BHM, Castillo-Cerda M, Valdes-Badilla P. Effects of active exergames on physical performance in older people: an overview of systematic reviews and meta-analysis. Front Public Health. 2024 Apr 9;12:1250299. doi: 10.3389/fpubh.2024.1250299. eCollection 2024.
citation: Taylor LM, Kerse N, Frakking T, Maddison R. Active Video Games for Improving Physical Performance Measures in Older People: A Meta-analysis. J Geriatr Phys Ther. 2018 Apr/Jun;41(2):108-123. doi: 10.1519/JPT.0000000000000078.
citation: Suleiman-Martos N, Garcia-Lara R, Albendin-Garcia L, Romero-Bejar JL, Canadas-De La Fuente GA, Monsalve-Reyes C, Gomez-Urquiza JL. Effects of active video games on physical function in independent community-dwelling older adults: A systematic review and meta-analysis. J Adv Nurs. 2022 May;78(5):1228-1244. doi: 10.1111/jan.15138. Epub 2021 Dec 21.