- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950528
Monocular-Camera-Based Mobile Exergame for Type 2 Diabetes Prevention
Development and Evaluation of a Monocular-Camera-Based Mobile Exergame for At-Home Intervention in Individuals at High Risk of Type 2 Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200240
- Hongqiao Community
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Receive traditional offline exercise with printed instructions
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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
|
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Active Comparator: Kinect group
Use Kinect based mobile exergame
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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
|
|
Experimental: Monocular group
Used monocular-camera-based exergame
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: Baseline, Immediately after the intervention
|
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
Time Frame: Baseline, Immediately after the intervention
|
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.
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Baseline, Immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Game experience
Time Frame: Immediately after the intervention
|
At the first session of intervention, participants in the Kinect and monocular groups completed the Game Experience Questionnaire (GEQ) to assess their user experience[19].
The GEQ was used to evaluate and compare the impact of different technologies on immersion and the overall experience of exergames.
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Immediately after the intervention
|
|
Intrinsic motivation
Time Frame: Immediately after the intervention
|
Furthermore, the Interest/Enjoyment Subscale of the Intrinsic Motivation Inventory (IMI) was administered to participants in the control group, Kinect group, and monocular group[20].
This subscale evaluated and compared intrinsic motivation and enjoyment associated with physical activity across the three groups.
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Immediately after the intervention
|
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User engagement
Time Frame: Follow-up (one week after the intervention)
|
At the end of one-week experiment period, user engagement was further quantified by tracking the frequency of intervention use over the one-week period, based on participants' video-recorded usage logs.
|
Follow-up (one week after the intervention)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRSY202504100034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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