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

Effectiveness of Interactive Exergaming Combined With the Otago Exercise Program on Mobility in Older Individuals Living in Communities: A Cluster-Randomized Controlled Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06814678
Acronym
GAME-OEP
Enrollment
100
Registered
2025-02-07
Start date
2025-02-11
Completion date
2026-03-31
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief 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.

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.

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.

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

Sponsors

National Taiwan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor who performs all measurements and evaluations will be blinded to group allocation throughout the study period. This assessor will not be involved in intervention delivery or have any contact with participants during exercise sessions to maintain masking

Intervention 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

Eligibility

Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Mobility PerformanceBaseline, 12 weeks, 3 monthsMeasured by Short Physical Performance Battery (SPPB) Scale: 0-12 points, higher scores indicate better performance
Lower Extremity StrengthBaseline, 12 weeks, 3 monthsMeasured by digital dynamometer Unit: Kilograms (kg)

Secondary

MeasureTime frameDescription
Intrinsic Capacity Scorebaseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)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.
Loneliness LevelMeasured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)Three-Item Loneliness Scale (T-ILS) Assessment of loneliness using T-ILS. Scale: 3-9 points, lower scores indicate less loneliness
Depression SymptomsMeasured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)Assessment of depression symptoms using Geriatric Depression Scale-5 (GDS-5). Scale: 0-5 points, lower scores indicate less depressive symptoms
Well-being StatusMeasured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)Assessment of well-being using 9-item Well-being Scale. Scale: 9-45 points, higher scores indicate better well-being.

Countries

Taiwan

Contacts

Primary ContactJIA-JING SUN, MS
c22881@gmail.com+886966040719

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026