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| ID | Type | Description | Link |
|---|---|---|---|
| Taiwan Nurses Association | Other Grant/Funding Number | TWNA-1141004 |
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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:
Who can take part:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Exergaming with Otago Exercise Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility Performance | Measured by Short Physical Performance Battery (SPPB) Scale: 0-12 points, higher scores indicate better performance | Baseline, 12 weeks, 3 months |
| Lower Extremity Strength | Measured by digital dynamometer Unit: Kilograms (kg) | Baseline, 12 weeks, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intrinsic Capacity Score | omprehensive assessment of intrinsic capacity using Integrated Care for Older People (ICOPE) screening tool, measuring six domains:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIA-JING SUN, MS | Contact | +886966040719 | c22881@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan | Taipei | Taipei | 111024 | Taiwan |
Protection of participant privacy and confidentiality. Institutional policies and ethical review board requirements.
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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
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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
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| Control Group with Usual Care | Other | 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 |
|
| 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 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 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 at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2) |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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