Clinical trial NCT06814678: Interactive Exergaming With Otago Exercise Program on Mobility in Community-Dwelling Older Adults
Official title: Effectiveness of Interactive Exergaming Combined With the Otago Exercise Program on Mobility in Older Individuals Living in Communities: A Cluster-Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Functional Performance
Psychological Health
Physical Fitness
Mobility Limitation
Aging
Keywords: Otago Exercise Program
Interactive exergaming
Mobility decline
Community-dwelling older adults
Physical performance
Intrinsic capacity
Psychological health
Muscle strength
Lead sponsor: National Taiwan University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mobility Performance
timeFrame: Baseline, 12 weeks, 3 months
measure: Lower Extremity Strength
timeFrame: Baseline, 12 weeks, 3 months
Secondary outcomes:
measure: Intrinsic Capacity Score
timeFrame: baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
measure: Loneliness Level
timeFrame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
measure: Depression Symptoms
timeFrame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
measure: Well-being Status
timeFrame: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan
Study officials:
References: