Frailty at Older AdultsNCT07191613
Effects of HAPPY GO GO Game on Health of Rural Elderly
A study testing HAPPY GO GO Somatosensory Game in people with Frailty at Older Adults and Health Promotion, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty at Older Adults, Health Promotion
- What is being tested?
- HAPPY GO GO Somatosensory Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Aug 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Not actually residing in the community.
- Unable to comply with the intervention program.
- Cognitive impairment or inability to cooperate with data collection.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung University of Science and Technology, Chiayi Campus
Chiayi City
About this study
Official title: Effects of the HAPPY GO GO Somatosensory Game on Physical and Mental Health of Rural Community-Dwelling Elderly
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.
- Conditions
- Frailty at Older Adults, Health Promotion
- Being tested
- HAPPY GO GO Somatosensory Game
- Keywords
- Somatosensory Game, Community-Dwelling Elderly, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPPY GO GO Somatosensory GameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start21 Aug 2025
- Primary completion31 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty at Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191613
- Sponsor's protocol ID
- 114-0548
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the HAPPY GO GO Somatosensory Game on Physical and Mental Health of Rural Community-Dwelling Elderly
- ClinicalTrials.gov ID
- NCT07191613
- Acronym / sponsor ID
- 114-0548
- Conditions
- Frailty at Older Adults, Health Promotion
- Keywords
- Somatosensory Game, Community-Dwelling Elderly, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAPPY GO GO Exergame | Experimental | Behavioral: HAPPY GO GO Somatosensory GameParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Not actually residing in the community.
- Unable to comply with the intervention program.
- Cognitive impairment or inability to cooperate with data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAPPY GO GO Somatosensory GameParticipants 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. | Behavioural | HAPPY GO GO Exergame |
Primary outcome
Change in Frailty Status
Time frame: Baseline and 12 weeks after intervention
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
Change in Lower Limb Flexibility
Time frame: Baseline and 12 weeks after intervention
Flexibility of the lower limbs will be assessed using the chair sit-and-reach test. Higher scores (in centimeters) indicate better flexibility.
Change in Upper Limb Flexibility
Time frame: Baseline and 12 weeks after intervention.
Flexibility of the upper limbs will be assessed using the back scratch test. Higher scores (in centimeters) indicate better flexibility.
Change in Agility and Dynamic Balance
Time frame: Baseline and 12 weeks after intervention
Agility and dynamic balance will be assessed using the 2.44-meter timed up-and-go test. Shorter times indicate better performance.
Change in Muscle Strength
Time frame: Baseline and 12 weeks after intervention
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.
Change in Cardiopulmonary Endurance
Time frame: Baseline and 12 weeks after intervention
Cardiopulmonary endurance will be measured using the 2-minute step test. Higher step counts indicate better endurance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAPPY GO GO Somatosensory Game in people with Frailty at Older Adults and Health Promotion, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Mar 2026. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Frailty Status (time frame: Baseline and 12 weeks after 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?
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 11 Mar 2026.