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Risk of FallsNCT07024004

Active Exergames Program in Older Adults at Risk of Falls

A study testing Exergame-Based Exercise + Conventional Physical Therapy and Conventional Physical Therapy in people with Risk of Falls, run by Universidad Catolica Silva Henriquez at 1 site in Chile.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Risk of Falls
What is being tested?
Exergame-Based Exercise + Conventional Physical Therapy and Conventional Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChile
Study dates
1 Apr 2025to 1 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Universidad Católica Silva Henríquez

    Santiago, Santiago Metropolitan

Other trials in Chile

About this study

Official title: Effects of Active Exergames Program on Muscle Strength, Lower Limb Muscle Mass and Physical Fitness in Older Adults at Risk of Falls

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?

Read more

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.
Read the 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.

Conditions
Risk of Falls
Being tested
Exergame-Based Exercise + Conventional Physical Therapy, Conventional Physical Therapy
Keywords
Exergames, Virtual Reality Exercise, Older Adults, Fall Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exergame-Based Exercise + Conventional Physical TherapyBehavioural

    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.

  • Conventional Physical TherapyBehavioural

    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.

Study groups in NCT07024004
Study groupRoleWhat they receive
Exergame-Based Exercise + Conventional Physical Therapy groupExperimentalParticipants 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.
Receives: Behavioral: Exergame-Based Exercise + Conventional Physical Therapy
Conventional Physical Therapy GroupActive comparatorParticipants 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.
Receives: Behavioral: Conventional Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 12 weeks post-intervention

  2. 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.

    Measured: Baseline and 12 weeks post-intervention

  3. Center of Pressure (COP)

    Posturography, which records center of pressure displacement while standing on a stable platform.

    Measured: Baseline and 12 weeks post-intervention

  4. 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.

    Measured: Baseline and 12 weeks post-intervention

  5. Static balance

    Single-Leg Stance Test (Unipedal Stance Test), where participants must maintain balance on one leg for at least 5 seconds.

    Measured: Baseline and 12 weeks post-intervention

  6. 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.

    Measured: Baseline and 12 weeks post-intervention

Secondary outcomes (5)
  1. 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.

    Measured: Baseline and 12 weeks post-intervention

  2. Handgrip strength

    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).

    Measured: Baseline and 12 weeks post-intervention

  3. 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.

    Measured: Baseline and 12 weeks post-intervention

  4. 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.

    Measured: Baseline and 12 weeks post-intervention

  5. 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.

    Measured: Baseline and 12 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07024004
Sponsor's protocol ID
ANID-NAM N°NAM24I0019
Status last verified
Jun 2025
First submitted
5 Apr 2025
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The informed consent signed by participants does not include authorization to share individual data publicly or with third parties.

Publications

  • 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.

    PubMed 38694976
  • 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.

    PubMed 38655514
  • 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.

    PubMed 26974212
  • 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.

    PubMed 34935178
  • 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.

    PubMed 41415308

Questions about this trial

What is this clinical trial studying?

A study testing Exergame-Based Exercise + Conventional Physical Therapy and Conventional Physical Therapy in people with Risk of Falls, run by Universidad Catolica Silva Henriquez at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of fall (time frame: Baseline and 12 weeks post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07024004, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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