ClinicalTrials.gg
Not yet recruitingNCT06814678GAME-OEPUpdated Feb 7, 2025

Interactive Exergaming with Otago Exercise Program on Mobility in Community-Dwelling Older Adults

An interventional study of Interactive Exergaming with Otago Exercise Program and Control Group with Usual Care in Physical Functional Performance, Psychological Health and Physical Fitness, sponsored by National Taiwan University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 65 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-07.

Primary conditionMobility LimitationRegistry: Psychological Well-BeingReclassifiedWhy we changed it
Registry
Psychological Well-Being — the first condition term the registry derived for this study.
ClinicalTrials.gg
Mobility Limitation
Why
  1. Psychological Well-Being is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Mobility Limitation.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Taiwan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years to 99 Years
Sex
All
01

Study 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. 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.

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:

  1. Warm-up (10 minutes):

    Head and neck rotations Back stretches Upper body rotation Lower limb stretches

  2. Otago Exercise Program (30 minutes):

    Knee lifts Ankle movements Knee extensions Standing exercises with support Heel-toe exercises Sit-to-stand practice

  3. Interactive Exergaming (20 minutes):

    Virtual soccer targeting lower limb strength Fruit Ninja for upper body engagement Alternating activities to prevent fatigue

  4. 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.

02

Conditions studied

  • Physical Functional Performance
  • Psychological Health
  • Physical Fitness
  • Mobility Limitation
  • Aging

Browse trials for

Keywords

  • Otago Exercise Program
  • Interactive exergaming
  • Mobility decline
  • Community-dwelling older adults
  • Physical performance
  • Intrinsic capacity
  • Psychological health
  • Muscle strength
03

In context

Mobility Limitation Reclassified

381 studies on the registry are indexed under Mobility Limitation; 108 are open to participants now.

This study's planned enrollment of 100 is above the median of 46 across 316 interventional studies indexed under Mobility Limitation.

Browse Mobility Limitation studies →

Lead sponsor

National Taiwan University is the lead sponsor of 22 studies on the registry; 7 are open to participants now.

Compared within Mobility Limitation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
65 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 65 years
  • Abnormal mobility based on ICOPE screening (Five-time chair stand test > 12 seconds)
  • Able to stand holding handrail for > 30 seconds

Exclusion criteria

Exclusion Criteria:

  • Severe visual impairment
  • Lower limb fracture
  • Acute serious illness
  • Moderate to severe cognitive impairment (SPMSQ > 5 errors)
  • Diagnosed psychiatric disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Placebo comparator
    Control Group with Usual Care

    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

    Other: Control Group with Usual Care

  • Experimental
    Interactive Exergaming with Otago Exercise Program

    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.

    Behavioral: Interactive Exergaming with Otago Exercise Program

Interventions

  • BehavioralInteractive Exergaming with Otago Exercise Program

    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.

  • OtherControl Group with Usual Care

    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

06

What researchers measure

Primary outcomes

  1. Mobility Performance

    Measured by Short Physical Performance Battery (SPPB) Scale: 0-12 points, higher scores indicate better performance

    Time frame: Baseline, 12 weeks, 3 months

  2. Lower Extremity Strength

    Measured by digital dynamometer Unit: Kilograms (kg)

    Time frame: Baseline, 12 weeks, 3 months

Secondary outcomes

  1. 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.

    Time frame: baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

  2. Loneliness Level

    Three-Item Loneliness Scale (T-ILS) Assessment of loneliness using T-ILS. Scale: 3-9 points, lower scores indicate less loneliness

    Time frame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

  3. Depression Symptoms

    Assessment of depression symptoms using Geriatric Depression Scale-5 (GDS-5). Scale: 0-5 points, lower scores indicate less depressive symptoms

    Time frame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

  4. Well-being Status

    Assessment of well-being using 9-item Well-being Scale. Scale: 9-45 points, higher scores indicate better well-being.

    Time frame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

07

Study locations

1 site
  • No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan
    Taipei, 111024, Taiwan
08

References and documents

Individual participant data

Plan to share: No — Protection of participant privacy and confidentiality. Institutional policies and ethical review board requirements.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Dec 2025, 10 months later.

Of 198 non-industry interventional studies with no phase under Mobility Limitation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 10 months is below that.

Counting every sponsor, half of 203 studies reached it within 18 months; a quarter within 8 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2025
First posted
Feb 7, 2025
StartEst.
Feb 11, 2025
Primary completionEst.
Dec 15, 2025
CompletionEst.
Mar 31, 2026
Last update
Feb 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06814678
Lead sponsor
National Taiwan University
Responsible party
JIA-JING SUN (PhD Candidate, Registered Nurse, National Taiwan University) — Principal investigator
First posted
Feb 7, 2025
Start date
Feb 11, 2025 (estimated)
Primary completion
Dec 15, 2025 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Feb 7, 2025

Study contacts

JIA-JING SUN, MS
Contact
c22881@gmail.com
+886966040719

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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