Augmented Reality Location-Based Games on Physical Activity (AR on PA)

March 28, 2025 updated by: Taipei Medical University

The Impact of Augmented Reality Location-Based Games on Physical Activity in Middle-Aged and Older Adults.

This study aims to examine the effects of an augmented reality location-based game intervention on behavioral and psychological factors related to physical activity among middle-aged and older adults. The study adopts a quasi-experimental design, targeting community-dwelling individuals aged 40-59 or 60 and above, who engage in sedentary work patterns exceeding 6 hours daily. Recruitment is scheduled to commence in February 2025 at the Xinyi Health Service Center in Taipei City. Participants will be assigned to either the experimental group or the control group based on enrollment timing. A minimum of 41 participants will be recruited, divided into two experimental groups and two control groups. The experimental group will participate in an augmented reality location-based game featuring different step count goals every two weeks, daily step count reporting, and goal achievement encouragement. The control group will maintain their usual routines without any intervention. The intervention will last for 8 weeks. Research instruments will include a basic demographic questionnaire, the short-form Taiwan Physical Activity Questionnaire, the Exercise Self-Efficacy Scale, the Exercise Motivation and Barriers Scale, blood pressure measurements, and the Quality of Life Scale.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hsin-Yen Yen, PhD
  • Phone Number: 6326 +886-2-27361661
  • Email: kenji@tmu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Meet one of the following conditions: middle-aged to senior citizens aged 40 to 59 years old or senior citizens aged 60 years old or older who work more than 6 hours a day in a sedentary lifestyle
  2. Able to walk independently without the use of aids.
  3. Have a smart phone with an application (Pikmin Bloom) that can be installed and can access the Internet and GPS.

Exclusion Criteria:

  1. Patients who have been diagnosed by a doctor as suffering from dementia, mental illness or major diseases.
  2. Those who are unable to do intense exercise as mentioned in the medical advice.
  3. Those who cannot go out for long time, such as family caregivers.
  4. Those who have regular exercise habits: average daily steps over 5,000 steps or 30 minutes of leisure-type physical activity more than 3 times a week.
  5. Those who will not use the AR adaptive game (Pikmin Bloom) at the end of the 2-day test period.

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Augmented Reality Location-Based Games
Behavioral: AR location-based game
This study aims to utilize the AR location-based game Pikmin Bloom to gradually encourage middle-aged and older adults in the community to develop a habit of walking outdoors. A step goal will be set every two weeks to progressively increase daily walking activity. By integrating the AR game with a LINE chatbot for feedback and engagement, this approach aims to motivate older adults, enhance their willingness to go outside, and increase their daily step count.
No Intervention: Control arm
The control group will maintain their usual routines without any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire short-form
Time Frame: Baseline, through study completion, an average of 12 weeks
It consists of 7 items that ask about physical activity over the last 7 days. These items cover vigorous activities, moderate activities, walking, and sitting (MET-minute/week)
Baseline, through study completion, an average of 12 weeks
Exercise Self-Efficacy Scale
Time Frame: Baseline, through study completion, an average of 12 weeks
Participants achieved a response if they scored an exercise self-efficacy score between 1 and 10.
Baseline, through study completion, an average of 12 weeks
The Exercise Motivation and Barriers Scale
Time Frame: Baseline, through study completion, an average of 12 weeks
It typically includes a series of statements related to exercise benefits and barriers. Participants rate their agreement with each statement on a Likert scale (5 strongly agree to 1 strongly disagree)
Baseline, through study completion, an average of 12 weeks
WHO Quality of Life Scale.
Time Frame: Baseline, through study completion, an average of 12 weeks
A shorter version with 26 questions. The scale evaluates various aspects of life, including physical health, psychological state, social relationships, and environmental factors, scored between 1 and 5.
Baseline, through study completion, an average of 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Baseline, through study completion, an average of 12 weeks
Electronic blood pressure monitor
Baseline, through study completion, an average of 12 weeks
Body composition
Time Frame: Baseline, through study completion, an average of 12 weeks
Tanita Body composition monitors
Baseline, through study completion, an average of 12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N202412060

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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