Physical Functional PerformanceGAME-OEPNCT06814678
Interactive Exergaming With Otago Exercise Program on Mobility in Community-Dwelling Older Adults
A study testing Interactive Exergaming with Otago Exercise Program in people with Physical Functional Performance and Psychological Health, run by National Taiwan University at 1 site in Taiwan.
Trial summary
This clinical trial aims to evaluate the effectiveness of interactive exergaming combined with Otago Exercise Program on mobility among community-dwelling older adults aged 65 and above. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Physical Functional Performance, Psychological Health, Physical Fitness
- What is being tested?
- Interactive Exergaming with Otago Exercise Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Feb 2025to 31 Mar 2026
- 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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Abnormal mobility based on ICOPE screening (Five-time chair stand test > 12 seconds)
- Able to stand holding handrail for > 30 seconds
Who cannot join
- Severe visual impairment
- Lower limb fracture
- Acute serious illness
- Moderate to severe cognitive impairment (SPMSQ > 5 errors)
- Diagnosed psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan
Taipei, Taipei, 111024
JIA-JING SUN, 0966040719, c22881@gmail.com
c22881@gmail.com
About this study
Official title: Effectiveness of Interactive Exergaming Combined With the Otago Exercise Program on Mobility in Older Individuals Living in Communities: A Cluster-Randomized Controlled Study
This clinical trial aims to evaluate the effectiveness of interactive exergaming combined with Otago Exercise Program on mobility among community-dwelling older adults aged 65 and above. The main research questions are:
Does this combined exercise intervention improve elderly mobility? Does this program enhance muscle strength and psychological well-being?
Read more
Researchers will compare two groups: one group will do the combined exercise program for 12 weeks, while the other group will continue their usual activities.
Participants will:
- Have their health checked three times: at the start, after 12 weeks, and 3 months later
- If in the exercise group, attend exercise sessions twice a week for 12 weeks
- Complete tests about their physical abilities and how they feel emotionally
Who can take part:
- Adults age 65 or older
- People who need more than 12 seconds to stand up and sit down 5 times
- People who can stand for at least 30 seconds with support
People cannot take part if they have serious vision problems, recent leg injuries, major illnesses, significant memory problems, or mental health conditions.
Read the detailed description
This cluster-randomized controlled trial investigates the integration of interactive exergaming with the evidence-based Otago Exercise Program (OEP) to enhance mobility among community-dwelling older adults. The study employs comprehensive methodology and rigorous assessment protocols to evaluate intervention effectiveness.
Methodology and Technical Implementation:
Assessment Tools and Measurements:
Primary Outcome Measures:
ICOPE (Integrated Care for Older People) screening tool evaluating six domains: cognition, mobility, nutrition, vision, hearing, and depression
Short Physical Performance Battery (SPPB, ICC=0.81-0.91) measuring:
Balance (side-by-side, semi-tandem, tandem stance) Gait speed (3-meter walk test) Lower extremity strength (5-time sit-to-stand)
Lower extremity muscle strength assessment using MicroFET2 digital dynamometer (accuracy ±1%):
Quadriceps strength Ankle dorsiflexion Hip abduction
Secondary Outcome Measures:
Three-Item Loneliness Scale (T-ILS, Cronbach's α=0.87) Geriatric Depression Scale-5 (GDS-5) Well-being Scale for Older Adults (9 items, Cronbach's α=0.91)
Intervention Protocol Design:
Exercise Program Structure:
12-week intervention period Two 60-minute sessions per week (120 minutes total) Group format (10-25 participants) Led by certified OEP trainers Integration of Nex Playground exergaming system
Session Components:
- Warm-up (10 minutes): Head and neck rotations Back stretches Upper body rotation Lower limb stretches
- Otago Exercise Program (30 minutes): Knee lifts Ankle movements Knee extensions Standing exercises with support Heel-toe exercises Sit-to-stand practice
- Interactive Exergaming (20 minutes): Virtual soccer targeting lower limb strength Fruit Ninja for upper body engagement Alternating activities to prevent fatigue
- Cool-down (10 minutes): Stretching exercises Relaxation techniques Technical Implementation: Equipment and Setting: Spacious, well-ventilated rooms Sturdy chairs with armrests Nex Playground gaming system Large display screen/projector Non-slip exercise mats Safety rails/supports Safety Protocols: Environmental risk assessment Fall prevention measures Emergency response procedures Continuous monitoring by trained staff Regular equipment maintenance Quality Control Measures: Standardization: Assessor training (ICC > 0.80 required) Intervention delivery protocols Documentation procedures Data collection methods Blinding: Outcome assessors blinded to group allocation Separate staff for intervention and assessment Data coding for anonymity Monitoring: Attendance tracking Adverse event documentation Intervention fidelity checks Regular team meetings Statistical Analysis Framework: Primary Analysis: Intention-to-treat principle Generalized Estimating Equations (GEE) Repeated measures analysis Cluster-level adjustments Data Management: Coded data entry Regular quality checks Missing data protocols Interim analyses Methodological Considerations: Cluster Randomization: Unit of randomization: community centers Stratification by center size Baseline characteristic balance Intraclass correlation adjustment Potential Challenges: Participant adherence Technology acceptance Health status changes Environmental factors Measurement biases Risk Mitigation: Regular communication Technical support Flexible scheduling Safety monitoring Modified exercises when needed Innovation and Scientific Contribution: This study offers several innovative aspects: Integration of traditional exercise with modern technology Comprehensive assessment of physical and psychological outcomes Rigorous methodology in community settings Focus on functional mobility and engagement Potential for scalability and sustainability The protocol addresses key challenges in elderly exercise programs by: Enhancing engagement through interactive technology Maintaining safety with structured progression Providing social interaction opportunities Enabling objective measurement of outcomes Supporting long-term adherence This research contributes to the field by: Evaluating a novel intervention approach Generating evidence for technology-enhanced exercise Addressing both physical and psychological outcomes Providing implementation guidance for community programs Supporting active aging initiatives The study's comprehensive approach and rigorous methodology aim to provide valuable evidence for improving mobility interventions in community-dwelling older adults, with potential implications for public health policy and clinical practice.
- Conditions
- Physical Functional Performance, Psychological Health, Physical Fitness, Mobility Limitation, Aging
- Being tested
- Interactive Exergaming with Otago Exercise Program, Control Group with Usual Care
- Keywords
- Otago Exercise Program, Interactive exergaming, Mobility decline, Community-dwelling older adults, Physical performance, Intrinsic capacity, Psychological health, Muscle strength
- Medical subject headings
- Psychological Well-Being, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Exergaming with Otago Exercise ProgramBehavioural
Participants will receive a 12-week structured program combining interactive exergaming and Otago Exercise Program. Sessions include balance training, strength exercises, and functional mobility activities delivered through interactive gaming platforms, supervised by trained instructors.
Control Group with Usual CareOther
Participants will maintain their regular activities at community centers or facilities, including cognitive therapy, oral exercises, and upper limb training programs, during the 12-week study period
| Study group | Role | What they receive |
|---|---|---|
| Control Group with Usual Care | Placebo comparator | Participants in the control group will maintain their usual daily activities and routine care without any specific exercise intervention during the 12-week study period. They will receive standard health education materials and regular check-ups but no structured exercise program Receives: Other: Control Group with Usual Care |
| Interactive Exergaming with Otago Exercise Program | Experimental | A 12-week structured program consisting of 120 minutes per week divided into two 60-minute sessions. Each session combines Otago Exercise Program for strength and balance with interactive exergaming activities, conducted in community centers under certified instructor supervision with standardized equipment. Exercise intensity progresses according to individual performance. Receives: Behavioral: Interactive Exergaming with Otago Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility Performance
Measured by Short Physical Performance Battery (SPPB) Scale: 0-12 points, higher scores indicate better performance
Measured: Baseline, 12 weeks, 3 months
Lower Extremity Strength
Measured by digital dynamometer Unit: Kilograms (kg)
Measured: Baseline, 12 weeks, 3 months
Secondary outcomes (4)
Intrinsic Capacity Score
omprehensive assessment of intrinsic capacity using Integrated Care for Older People (ICOPE) screening tool, measuring six domains:
- Cognition (3 memory items and orientation questions)
- Mobility (5-time sit-to-stand test)
- Nutrition (weight loss and appetite assessment)
- Vision (visual assessment)
- Hearing (whisper test)
- Depression (mood and interest assessment) For each domain, if any item within that domain is abnormal, the domain is scored as 0 (indicating risk of capacity decline); if all items are normal, the domain is scored as 1 (normal). Total score ranges from 0 (all domains at risk) to 6 (all domains normal), with higher scores indicating fewer domains at risk of capacity decline.
Measured: baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Loneliness Level
Three-Item Loneliness Scale (T-ILS) Assessment of loneliness using T-ILS. Scale: 3-9 points, lower scores indicate less loneliness
Measured: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Depression Symptoms
Assessment of depression symptoms using Geriatric Depression Scale-5 (GDS-5). Scale: 0-5 points, lower scores indicate less depressive symptoms
Measured: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Well-being Status
Assessment of well-being using 9-item Well-being Scale. Scale: 9-45 points, higher scores indicate better well-being.
Measured: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start11 Feb 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Functional PerformanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This cluster-randomized controlled trial uses parallel assignment where community centers are randomly allocated to either receive interactive exergaming combined with Otago Exercise Program intervention or usual care control group. All eligible participants within each cluster follow the same intervention protocol
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIA-JING SUN, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814678
- Sponsor's protocol ID
- 202412HM008
- Other IDs
- Taiwan Nurses Association
- Acronym
- GAME-OEP
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protection of participant privacy and confidentiality. Institutional policies and ethical review board requirements.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interactive Exergaming Combined With the Otago Exercise Program on Mobility in Older Individuals Living in Communities: A Cluster-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06814678
- Acronym / sponsor ID
- GAME-OEP / 202412HM008
- Conditions
- Physical Functional Performance, Psychological Health, Physical Fitness, Mobility Limitation, Aging
- Keywords
- Otago Exercise Program, Interactive exergaming, Mobility decline, Community-dwelling older adults, Physical performance, Intrinsic capacity, Psychological health, Muscle strength
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 11 Feb 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 7 Feb 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.
This clinical trial aims to evaluate the effectiveness of interactive exergaming combined with Otago Exercise Program on mobility among community-dwelling older adults aged 65 and above. The main research questions are:
Does this combined exercise intervention improve elderly mobility? Does this program enhance muscle strength and psychological well-being?
Researchers will compare two groups: one group will do the combined exercise program for 12 weeks, while the other group will continue their usual activities.
Participants will:
- Have their health checked three times: at the start, after 12 weeks, and 3 months later
- If in the exercise group, attend exercise sessions twice a week for 12 weeks
- Complete tests about their physical abilities and how they feel emotionally
Who can take part:
- Adults age 65 or older
- People who need more than 12 seconds to stand up and sit down 5 times
- People who can stand for at least 30 seconds with support
People cannot take part if they have serious vision problems, recent leg injuries, major illnesses, significant memory problems, or mental health conditions.
Detailed description
This cluster-randomized controlled trial investigates the integration of interactive exergaming with the evidence-based Otago Exercise Program (OEP) to enhance mobility among community-dwelling older adults. The study employs comprehensive methodology and rigorous assessment protocols to evaluate intervention effectiveness.
Methodology and Technical Implementation:
Assessment Tools and Measurements:
Primary Outcome Measures:
ICOPE (Integrated Care for Older People) screening tool evaluating six domains: cognition, mobility, nutrition, vision, hearing, and depression
Short Physical Performance Battery (SPPB, ICC=0.81-0.91) measuring:
Balance (side-by-side, semi-tandem, tandem stance) Gait speed (3-meter walk test) Lower extremity strength (5-time sit-to-stand)
Lower extremity muscle strength assessment using MicroFET2 digital dynamometer (accuracy ±1%):
Quadriceps strength Ankle dorsiflexion Hip abduction
Secondary Outcome Measures:
Three-Item Loneliness Scale (T-ILS, Cronbach's α=0.87) Geriatric Depression Scale-5 (GDS-5) Well-being Scale for Older Adults (9 items, Cronbach's α=0.91)
Intervention Protocol Design:
Exercise Program Structure:
12-week intervention period Two 60-minute sessions per week (120 minutes total) Group format (10-25 participants) Led by certified OEP trainers Integration of Nex Playground exergaming system
Session Components:
- Warm-up (10 minutes): Head and neck rotations Back stretches Upper body rotation Lower limb stretches
- Otago Exercise Program (30 minutes): Knee lifts Ankle movements Knee extensions Standing exercises with support Heel-toe exercises Sit-to-stand practice
- Interactive Exergaming (20 minutes): Virtual soccer targeting lower limb strength Fruit Ninja for upper body engagement Alternating activities to prevent fatigue
- Cool-down (10 minutes): Stretching exercises Relaxation techniques Technical Implementation: Equipment and Setting: Spacious, well-ventilated rooms Sturdy chairs with armrests Nex Playground gaming system Large display screen/projector Non-slip exercise mats Safety rails/supports Safety Protocols: Environmental risk assessment Fall prevention measures Emergency response procedures Continuous monitoring by trained staff Regular equipment maintenance Quality Control Measures: Standardization: Assessor training (ICC > 0.80 required) Intervention delivery protocols Documentation procedures Data collection methods Blinding: Outcome assessors blinded to group allocation Separate staff for intervention and assessment Data coding for anonymity Monitoring: Attendance tracking Adverse event documentation Intervention fidelity checks Regular team meetings Statistical Analysis Framework: Primary Analysis: Intention-to-treat principle Generalized Estimating Equations (GEE) Repeated measures analysis Cluster-level adjustments Data Management: Coded data entry Regular quality checks Missing data protocols Interim analyses Methodological Considerations: Cluster Randomization: Unit of randomization: community centers Stratification by center size Baseline characteristic balance Intraclass correlation adjustment Potential Challenges: Participant adherence Technology acceptance Health status changes Environmental factors Measurement biases Risk Mitigation: Regular communication Technical support Flexible scheduling Safety monitoring Modified exercises when needed Innovation and Scientific Contribution: This study offers several innovative aspects: Integration of traditional exercise with modern technology Comprehensive assessment of physical and psychological outcomes Rigorous methodology in community settings Focus on functional mobility and engagement Potential for scalability and sustainability The protocol addresses key challenges in elderly exercise programs by: Enhancing engagement through interactive technology Maintaining safety with structured progression Providing social interaction opportunities Enabling objective measurement of outcomes Supporting long-term adherence This research contributes to the field by: Evaluating a novel intervention approach Generating evidence for technology-enhanced exercise Addressing both physical and psychological outcomes Providing implementation guidance for community programs Supporting active aging initiatives The study's comprehensive approach and rigorous methodology aim to provide valuable evidence for improving mobility interventions in community-dwelling older adults, with potential implications for public health policy and clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This cluster-randomized controlled trial uses parallel assignment where community centers are randomly allocated to either receive interactive exergaming combined with Otago Exercise Program intervention or usual care control group. All eligible participants within each cluster follow the same intervention protocol
| Arm | Type | Receives |
|---|---|---|
| Control Group with Usual Care | Placebo comparator | Other: Control Group with Usual CareParticipants in the control group will maintain their usual daily activities and routine care without any specific exercise intervention during the 12-week study period. They will receive standard health education materials and regular check-ups but no structured exercise program |
| Interactive Exergaming with Otago Exercise Program | Experimental | Behavioral: Interactive Exergaming with Otago Exercise ProgramA 12-week structured program consisting of 120 minutes per week divided into two 60-minute sessions. Each session combines Otago Exercise Program for strength and balance with interactive exergaming activities, conducted in community centers under certified instructor supervision with standardized equipment. Exercise intensity progresses according to individual performance. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years
- Abnormal mobility based on ICOPE screening (Five-time chair stand test > 12 seconds)
- Able to stand holding handrail for > 30 seconds
Key exclusion criteria (5 listed)
- Severe visual impairment
- Lower limb fracture
- Acute serious illness
- Moderate to severe cognitive impairment (SPMSQ > 5 errors)
- Diagnosed psychiatric disorders
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 |
|---|---|---|
| Interactive Exergaming with Otago Exercise ProgramParticipants will receive a 12-week structured program combining interactive exergaming and Otago Exercise Program. Sessions include balance training, strength exercises, and functional mobility activities delivered through interactive gaming platforms, supervised by trained instructors. | Behavioural | Interactive Exergaming with Otago Exercise Program |
| Control Group with Usual CareParticipants will maintain their regular activities at community centers or facilities, including cognitive therapy, oral exercises, and upper limb training programs, during the 12-week study period | Other | Control Group with Usual Care |
Primary outcome
Mobility Performance
Time frame: Baseline, 12 weeks, 3 months
Measured by Short Physical Performance Battery (SPPB) Scale: 0-12 points, higher scores indicate better performance
Lower Extremity Strength
Time frame: Baseline, 12 weeks, 3 months
Measured by digital dynamometer Unit: Kilograms (kg)
4 secondary outcomes
Intrinsic Capacity Score
Time frame: baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Loneliness Level
Time frame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Depression Symptoms
Time frame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Well-being Status
Time frame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No. Protection of participant privacy and confidentiality. Institutional policies and ethical review board requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Exergaming with Otago Exercise Program in people with Physical Functional Performance and Psychological Health, run by National Taiwan University 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 5 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: opening soon, as of the sponsor's last update on 7 Feb 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 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. Some participants in this study may receive a placebo. 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?
Contact JIA-JING SUN, MS (+886966040719, c22881@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility Performance (time frame: Baseline, 12 weeks, 3 months). The study lists 2 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 7 Feb 2025.