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| Name | Class |
|---|---|
| Agencia Nacional de Investigación y Desarrollo | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exergame-Based Exercise + Conventional Physical Therapy group | Experimental | Participants in this group will receive a combined intervention that includes multicomponent physical exercise and training using exergames (specifically Ring Fit Adventure on the Nintendo Switch). The sessions target strength, balance, and aerobic capacity and will be delivered twice a week for 12 weeks in senior care centers. |
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| Conventional Physical Therapy Group | Active Comparator | Participants in this group will receive a standard multicomponent physical exercise program including aerobic, strength, balance, and flexibility exercises, delivered twice a week for 12 weeks in senior care centers. No exergames or virtual reality components will be included in this intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exergame-Based Exercise + Conventional Physical Therapy | Behavioral | Participants in this group will engage in a combined intervention consisting of: Multicomponent physical exercise (aerobic, strength, balance, and flexibility), delivered twice per week for 12 weeks. Exergames training using the Nintendo Switch console and Ring Fit Adventure game. Sessions include warm-up, gameplay involving full-body movements (e.g., squats, running, balance tasks), and cooldown. Sessions are adapted to individual physical capacities and supervised by a trained kinesiologist. The intensity is monitored using the Borg Scale, following ACSM guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of fall | 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. | Baseline and 12 weeks post-intervention |
| Functional Independence | 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. | Baseline and 12 weeks post-intervention |
| Center of Pressure (COP) | Posturography, which records center of pressure displacement while standing on a stable platform. | Baseline and 12 weeks post-intervention |
| Dynamic balance | 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. | Baseline and 12 weeks post-intervention |
| Static balance | Single-Leg Stance Test (Unipedal Stance Test), where participants must maintain balance on one leg for at least 5 seconds. | Baseline and 12 weeks post-intervention |
| Aerobic capacity | 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. | Baseline and 12 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| body composition | 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. | Baseline and 12 weeks post-intervention |
| Handgrip strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paloma Lillo Urzúa, MSc | Universidad Católica Silva Henríquez | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica Silva Henríquez | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38694976 | Result | 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. | |
| 38655514 | Result | 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. |
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The informed consent signed by participants does not include authorization to share individual data publicly or with third parties.
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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.
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| Conventional Physical Therapy | Behavioral | Participants in this group will receive a standard multicomponent physical exercise program consisting of: Exercises for aerobic capacity, strength, balance, and flexibility. Delivered in-person twice per week for 12 weeks at senior care centers. Sessions include warm-up (5-10 min), main activity (30-40 min), and cooldown (5-10 min). Intensity is controlled using the Borg Scale and monitored by a supervising kinesiologist. |
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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). |
| Baseline and 12 weeks post-intervention |
| Lower Limb Muscle Strength | 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. | Baseline and 12 weeks post-intervention |
| Intramuscular Fat Infiltration | 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. | Baseline and 12 weeks post-intervention |
| Muscle Architecture | 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. | Baseline and 12 weeks post-intervention |
| 26974212 | Result | 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. |
| 34935178 | Result | 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. |
| 41415308 | Derived | Lillo-Urzua P, Ugarte-Llanten J, Carreno-Zilmann G, Vidal-Seguel N, Guede-Rojas F, Cuenca-Garcia M, Cigarroa I. E-ACTIVE AGING study protocol: Evaluating an exergame-based and multicomponent exercise program for community-dwelling older adults at risk of falling. Front Physiol. 2025 Dec 3;16:1691454. doi: 10.3389/fphys.2025.1691454. eCollection 2025. |