Interactive Exergaming with Otago Exercise Program on Mobility in Community-Dwelling Older Adults (GAME-OEP)

February 2, 2025 updated by: JIA-JING SUN, National Taiwan University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111024
        • No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan
        • Contact:
        • Contact:
        • Contact:
          • JIA-JING Sun, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group with Usual Care
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
Other: Control Group with Usual Care
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
Experimental: Interactive Exergaming with Otago Exercise Program
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.
Behavioral: Interactive 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrinsic Capacity Score
Time Frame: 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.
baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Loneliness Level
Time Frame: 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
Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Depression Symptoms
Time Frame: 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
Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)
Well-being Status
Time Frame: 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.
Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 11, 2025

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202412HM008
  • Taiwan Nurses Association (Other Grant/Funding Number: TWNA-1141004)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protection of participant privacy and confidentiality. Institutional policies and ethical review board requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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