Active Exergames Program in Older Adults at Risk of Falls

NCT07024004 | Active Not Recruiting DMC

• 1 other identifier: ANID-NAM N°NAM24I0019
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk of Falls

Keywords

Exergames; Virtual Reality Exercise; Older Adults; Fall Prevention

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (5)

• body composition

  Baseline and 12 weeks post-intervention

• Handgrip strength

  Baseline and 12 weeks post-intervention

• Lower Limb Muscle Strength

  Baseline and 12 weeks post-intervention

• Intramuscular Fat Infiltration

  Baseline and 12 weeks post-intervention

• Muscle Architecture

  Baseline and 12 weeks post-intervention

Study Arms (2)

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.

Behavioral: Exergame-Based Exercise + Conventional Physical Therapy

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.

Behavioral: Conventional Physical Therapy

Interventions

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.

Exergame-Based Exercise + Conventional Physical Therapy group

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.

Conventional Physical Therapy Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Catolica Silva Henriquez: lead
• Agencia Nacional de Investigacion y Desarrollo, ANID: collaborator

Study Sites (1)

Universidad Católica Silva Henríquez

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (5)

• 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.

  PMID: 38694976 BACKGROUND

• 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.

  PMID: 38655514 BACKGROUND

• 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.

  PMID: 26974212 BACKGROUND

• 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.

  PMID: 34935178 BACKGROUND

• 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.

  PMID: 41415308 DERIVED

Study Officials

• Paloma Lillo Urzúa, MSc

  Universidad Católica Silva Henríquez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: June 17, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)