NCT06950528

Brief Summary

Exergames have demonstrated potential as effective interventions for promoting physical activity and preventing type 2 diabetes (T2D), particularly among older adults. Kinect-based exergames, in particular, have been associated with improved adherence to exercise regimens and positive health outcomes. However, widespread implementation is limited by the high cost and reduced accessibility of the required hardware, restricting their use in home-based settings. Recent advances in computer vision have enabled the development of exergames using monocular camera systems, which may represent a cost-effective and scalable alternative. This study investigates the feasibility of monocular-camera-based exergames as a cost-effective and convenient alternative for home-dwelling individuals. A total of 45 community-dwelling older adults aged 60-74 years, identified as high risk for T2D were recruited through local community health centers. Participants were randomly assigned to one of three groups (n = 15 per group): (1) Control group (traditional offline exercise with printed instructions), (2) Kinect group (Kinect-based exergames targeting aerobic capacity, balance, and strength), and (3) Monocular group (monocular-camera-based exergames using real-time 2D pose estimation). The intervention lasted six weeks, with participants completing three 30-minute sessions per week at home. Primary outcomes included exercise performance (completion rate and movement accuracy) and intrinsic motivation. Secondary outcomes included perceived enjoyment, challenge, and usability. Data were analyzed using one-way ANOVA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 10, 2025

Last Update Submit

April 25, 2025

Conditions

Keywords

ExergameIndividuals at High Risk of Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    The post-intervention heart rate was collected during the first 10 seconds post-exercise to estimate physiological responses. Considering the general physical condition of individuals at high risk of diabetes, the study used 50%-80% of the maximum heart rate as the target exercise intensity. The maximum heart rate was calculated using the formula: 208 - (age × 0.7).

    Baseline, Immediately after the intervention

  • Perceived fatigue

    perceived fatigue, a widely accepted parameter in exercise assessments for diabetes-related fields, was employed to supplement the evaluation of physical activity. The Borg RPE (Rating of Perceived Exertion) scale\[18\], ranging from 6 to 20, was utilized to assess subjective fatigue and compare perceived exercise intensity across groups.

    Baseline, Immediately after the intervention

Secondary Outcomes (3)

  • Game experience

    Immediately after the intervention

  • Intrinsic motivation

    Immediately after the intervention

  • User engagement

    Follow-up (one week after the intervention)

Study Arms (3)

Control group

ACTIVE COMPARATOR

Receive traditional offline exercise with printed instructions

Behavioral: Control group

Kinect group

ACTIVE COMPARATOR

Use Kinect based mobile exergame

Behavioral: Kinect group

Monocular group

EXPERIMENTAL

Used monocular-camera-based exergame

Behavioral: Monocular group

Interventions

Control groupBEHAVIORAL

Control Group consists of six motion videos, including: crossover steps, high knees, lateral raises, punching movements, downward leg punches from a standing position, and elbow-to-chest expansions

Control group
Kinect groupBEHAVIORAL

Kinect Group features the same software functionality and design as the application based on bullet-screen cameras, but the hardware is built using a Kinect sensor. The gamified platform is primarily developed and presented using Unity software. The Kinect 3D motion-sensing camera incorporates real-time dynamic capture and image recognition capabilities, offering new possibilities for interactive approaches to motion therapy

Kinect group
Monocular groupBEHAVIORAL

The game employs a virtual avatar to replicate users' movements, thereby fostering an immersive and engaging experience. A monocular camera captures users' movements in real time, which are analyzed through pose estimation algorithms and subsequently mapped onto the virtual avatar. Users interact with the game by following on-screen visual demonstrations, presented as either static images or animations, to perform the prescribed exercises. Movement accuracy is evaluated by the system, with scores awarded based on performance. To enhance user motivation and adherence, the game incorporates a reward system, where points earned through accurate execution can be redeemed for in-game rewards, such as unlocking background music, avatar customization options, and new virtual environments.

Monocular group

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 60-74;
  • a score of 25 or higher on the Chinese Diabetes Risk Score;
  • community-dwelling individuals, not reside in assisted living or long-term care facilities;
  • physically capable of engaging in light to moderate exercise, as determined by self-report and/or physician clearance;
  • normal cognitive function that enable the participant to complete the experiment independently or with minimal assistance;
  • Written informed consent provided by participants or their families.

You may not qualify if:

  • diagnosis of type 1 or type 2 diabetes;
  • current participation in another exercise intervention study;
  • severe cognitive impairment with MMSE \< 24;
  • major mobility limitations such as severe osteoarthritis and recent orthopedic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongqiao Community

Shanghai, Shanghai Municipality, 200240, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 30, 2025

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

August 1, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations