NCT07191613

Brief Summary

The goal of this quasi-experimental clinical trial is to evaluate the effects of the "HAPPY GO GO" somatosensory game on physical and mental health in community-dwelling older adults aged 65 years and above living in rural Chiayi County, Taiwan. The main questions it aims to answer are:

  • Does participation in the somatosensory game improve physical health outcomes (e.g., balance, mobility, functional fitness)?
  • Does participation improve mental health outcomes (e.g., mood, depressive symptoms)? Researchers will compare an intervention group, which participates in the game-based exercise program, with a control group that does not receive the intervention, to evaluate changes in health status. Participants in the intervention group will take part in structured game-based physical activity sessions over several weeks, designed to promote engagement, improve physical performance, and support psychological well-being.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

August 29, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

Somatosensory GameCommunity-Dwelling ElderlyMental Health

Outcome Measures

Primary Outcomes (6)

  • Change in Frailty Status

    Frailty will be assessed using the Study of Osteoporotic Fractures (SOF) Index, which consists of three items commonly used in Taiwan's Ministry of Health and Welfare community frailty screening program. The SOF Index has a score range from 0 to 3, where a higher score indicates greater frailty (worse outcome). Score = 0: Robust Score = 1: Pre-frail Score = 2-3: Frail

    Baseline and 12 weeks after intervention

  • Change in Lower Limb Flexibility

    Flexibility of the lower limbs will be assessed using the chair sit-and-reach test. Higher scores (in centimeters) indicate better flexibility.

    Baseline and 12 weeks after intervention

  • Change in Upper Limb Flexibility

    Flexibility of the upper limbs will be assessed using the back scratch test. Higher scores (in centimeters) indicate better flexibility.

    Baseline and 12 weeks after intervention.

  • Change in Agility and Dynamic Balance

    Agility and dynamic balance will be assessed using the 2.44-meter timed up-and-go test. Shorter times indicate better performance.

    Baseline and 12 weeks after intervention

  • Change in Muscle Strength

    Muscle strength will be assessed using the 30-second chair stand test (lower limb strength) and the 30-second biceps curl test (upper limb strength, 8 lbs men / 5 lbs women). Higher repetitions indicate better strength.

    Baseline and 12 weeks after intervention

  • Change in Cardiopulmonary Endurance

    Cardiopulmonary endurance will be measured using the 2-minute step test. Higher step counts indicate better endurance.

    Baseline and 12 weeks after intervention

Other Outcomes (1)

  • Change in Body Mass Index (BMI)

    Baseline and 12 weeks after intervention

Study Arms (2)

HAPPY GO GO Exergame

EXPERIMENTAL

Participants in the intervention group will engage in the "HAPPY GO GO" somatosensory exergame program. The intervention consists of structured game-based physical activity sessions, conducted once per week for a total duration of 12 weeks. Each session includes interactive, movement-based tasks designed to promote physical health, and mental well-being among community-dwelling older adults.

Behavioral: HAPPY GO GO Somatosensory Game

Usual Daily Activities

NO INTERVENTION

Participants in the control group will not receive the game-based intervention. They will continue with their usual daily activities without structured exercise sessions. Health outcomes will be assessed at baseline and post-intervention for comparison with the experimental group.

Interventions

Participants in the intervention group will engage in the "HAPPY GO GO" somatosensory exergame program. The intervention consists of structured game-based physical activity sessions, conducted once per week for a total duration of 12 weeks. Each session includes interactive, movement-based tasks designed to promote physical health, and mental well-being among community-dwelling older adults.

HAPPY GO GO Exergame

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling older adults aged 65 years or above living in rural areas of Chiayi County, Taiwan.
  • Clear consciousness and able to communicate in Mandarin or Taiwanese.
  • Willing to provide informed consent and participate in the study procedures.

You may not qualify if:

  • Not actually residing in the community.
  • Unable to comply with the intervention program.
  • Cognitive impairment or inability to cooperate with data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University of Science and Technology, Chiayi Campus

Chiayi City, Taiwan

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 25, 2025

Study Start

August 21, 2025

Primary Completion

January 31, 2026

Study Completion

February 28, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations