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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? 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.
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.
Age
65 - 99 years
Sex
ALL
Healthy Volunteers
No
No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan
Taipei, Taipei, Taiwan
Start Date
February 11, 2025
Primary Completion Date
December 15, 2025
Completion Date
March 31, 2026
Last Updated
February 7, 2025
100
ESTIMATED participants
Interactive Exergaming with Otago Exercise Program
BEHAVIORAL
Control Group with Usual Care
OTHER
Lead Sponsor
National Taiwan University
NCT07256717
NCT06212856
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06590103