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

Not Applicable

Not yet recruiting

• Conditions: Physical Functional Performance; Psychological Health; Physical Fitness; Mobility Limitation; Aging

• Registration Number: NCT06814678
• Lead Sponsor: National Taiwan University

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.

Study Timeline

• Study First Submitted: 2025-01-24
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Study Start: 2025-02-11
• Primary Completion: 2025-12-15
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mobility Performance	Baseline, 12 weeks, 3 months	Measured by Short Physical Performance Battery (SPPB) Scale: 0-12 points, higher scores indicate better performance
Lower Extremity Strength	Baseline, 12 weeks, 3 months	Measured by digital dynamometer Unit: Kilograms (kg)

Secondary Outcome Measures

Name	Time	Method
Intrinsic Capacity Score	baseline (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 Level	Measured 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 Symptoms	Measured 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 Status	Measured 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.

Trial Locations

Locations (1)

No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan; 🇨🇳 Taipei, Taiwan