- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02129023
The Impact of Exergame on User Health
The Impact of Exergame on User Health: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main hypotheses are:
H1: Compared with the control group participants (who do not use exergame) the experimental group participants (who use exergame) have better change in physical fitness. The difference between these two groups in the amount of change is negatively related to past exercise.
H2: Compared with the control group participants (who do not use exergame) the experimental group participants (who use exergame) have better change in (a) mental health and (b) physical health after the intervention. The difference between these two groups in the amount of change is negatively related to past exercise.
H3: Compared with the control group participants (who do not use exergame) the experimental group participants (who use exergame) have better change in (a) attitude, (b) intention and (c) behavior of doing another exercise in the future. The difference between these two groups in the amount of change is negatively related to past exercise.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taoyuan, Taiwan, 333
- Chang Gung University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- junior and senior undergraduate student
- senior graduate student
Exclusion Criteria:
- asthma
- high myopia
- anemia
- vertigo
- cardiopathy
- hypertension
- unstable of intracranial pressure and blood pressure
- cardiac arrhythmia
- heart failure
- angor pectoris
- injury of vertebra
- ankylosing spondylitis
- hereditary cardiac arrhythmia
- musculoskeletal system injury
- glaucoma
- psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exergame
Participants were asked to use exergame (Xbox 360) half hour for three times per week in the 12-week study period.
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For each participant in the experimental arm, two Xbox 360 exercise items were randomly selected from the nine items, which are related to user health.
Each participant takes the two exercise items in turn.
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No Intervention: control
Participants were not asked to use exergames.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical fitness
Time Frame: The beginning and the end of expected average of 12 weeks
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Physical fitness was assessed twice by Chang Gung Memorial Hospital, including body composition, cardio-pulmonary function, muscular strength, muscular endurance, explosive force, flexibility, agility, sense of balance, and cardiorespiratory endurance.
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The beginning and the end of expected average of 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mental and physical health (12 weeks)
Time Frame: The beginning and the end of expected average of 12 weeks
|
Self-rated mental and physical health, using the SF-36 scale.
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The beginning and the end of expected average of 12 weeks
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Change in attitude of future exercise (12 weeks)
Time Frame: The beginning and the end of expected average of 12 weeks
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Self-reported questionnaires assessing users' attitude toward future exercise between an expected average of 12 weeks since randomization.
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The beginning and the end of expected average of 12 weeks
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Change in intention of future exercise (12 weeks)
Time Frame: The beginning and the end of expected average of 12 weeks
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Self-reported questionnaires assessing users' intention to do exercise in the future between an expected average of 12 weeks since randomization.
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The beginning and the end of expected average of 12 weeks
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Change in behavior of future exercise (12 weeks)
Time Frame: The beginning and the end of expected average of 12 weeks
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Self-reported questionnaires assessing users' actual exercise behavior between an expected average of 12 weeks since randomization.
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The beginning and the end of expected average of 12 weeks
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Change in mental and physical health (8 weeks)
Time Frame: The beginning and the end of expected average of 8 weeks
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Self-rated mental and physical health, using the SF-36 scale.
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The beginning and the end of expected average of 8 weeks
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Change in attitude of future exercise (8 weeks)
Time Frame: The beginning and the end of expected average of 8 weeks
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Self-reported questionnaires assessing users' attitude toward future exercise between an expected average of 8 weeks since randomization.
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The beginning and the end of expected average of 8 weeks
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Change in intention of future exercise (8 weeks)
Time Frame: The beginning and the end of expected average of 8 weeks
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Self-reported questionnaires assessing users' intention to do exercise in the future between an expected average of 8 weeks since randomization.
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The beginning and the end of expected average of 8 weeks
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Change in behavior of future exercise (8 weeks)
Time Frame: The beginning and the end of expected average of 8 weeks
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Self-reported questionnaires assessing users' actual exercise behavior between an expected average of 8 weeks since randomization.
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The beginning and the end of expected average of 8 weeks
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Change in mental and physical health (4 weeks)
Time Frame: The beginning and the end of expected average of 4 weeks
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Self-rated mental and physical health, using the SF-36 scale.
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The beginning and the end of expected average of 4 weeks
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Change in attitude of future exercise (4 weeks)
Time Frame: The beginning and the end of expected average of 4 weeks
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Self-reported questionnaires assessing users' attitude toward future exercise between an expected average of 4 weeks since randomization.
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The beginning and the end of expected average of 4 weeks
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Change in intention of future exercise (4 weeks)
Time Frame: The beginning and the end of expected average of 4 weeks
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Self-reported questionnaires assessing users' intention to do exercise in the future between an expected average of 4 weeks since randomization.
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The beginning and the end of expected average of 4 weeks
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Change in behavior of future exercise (4 weeks)
Time Frame: The beginning and the end of expected average of 4 weeks
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Self-reported questionnaires assessing users' actual exercise behavior between an expected average of 4 weeks since randomization.
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The beginning and the end of expected average of 4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Challenge (beginning)
Time Frame: Beginning of the participation in this study
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Evaluated using scales measuing perceived challenge
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Beginning of the participation in this study
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Perceived Achievement (beginning)
Time Frame: Beginning of the participation in this study
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Evaluated using scales measuing perceived achievement
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Beginning of the participation in this study
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Continuance Intention (beginning)
Time Frame: Beginning of the participation in this study
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Evaluated using scales measuing intention to continue to use the exergame
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Beginning of the participation in this study
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Perceived Challenge (after 4 weeks)
Time Frame: After 4 weeks of the participation in this study
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Evaluated using scales measuing perceived challenge
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After 4 weeks of the participation in this study
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Perceived Achievement (after 4 weeks)
Time Frame: After 4 weeks of the participation in this study
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Evaluated using scales measuing perceived achievement
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After 4 weeks of the participation in this study
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Continuance Intention (after 4 weeks)
Time Frame: After 4 weeks of the participation in this study
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Evaluated using scales measuing intention to continue to use the exergame
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After 4 weeks of the participation in this study
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Perceived Challenge (after 8 weeks)
Time Frame: After 8 weeks of the participation in this study
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Evaluated using scales measuing perceived challenge
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After 8 weeks of the participation in this study
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Perceived Achievement (after 8 weeks)
Time Frame: After 8 weeks of the participation in this study
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Evaluated using scales measuing perceived achievement
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After 8 weeks of the participation in this study
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Continuance Intention (after 8 weeks)
Time Frame: After 8 weeks of the participation in this study
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Evaluated using scales measuing intention to continue to use the exergame
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After 8 weeks of the participation in this study
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Perceived Challenge (after 12 weeks)
Time Frame: After 12 weeks of the participation in this study
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Evaluated using scales measuing perceived challenge
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After 12 weeks of the participation in this study
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Perceived Achievement (after 12 weeks)
Time Frame: After 12 weeks of the participation in this study
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Evaluated using scales measuing perceived achievement
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After 12 weeks of the participation in this study
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Continuance Intention (after 12 weeks)
Time Frame: After 12 weeks of the participation in this study
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Evaluated using scales measuing intention to continue to use the exergame
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After 12 weeks of the participation in this study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ching-I Teng, PhD, Chang Gung University
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CMRPD3D0021
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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