Impact of Exergame Use on User HealthNCT02129023
The Impact of Exergame on User Health
A study testing Xbox 360 in people with Impact of Exergame Use on User Health, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The purpose of this study is to examine whether exergame use can improve user health, in terms of physical fitness, self-rated mental health and physical health, and favorable attitude, strong intention, and actual behavior of future exercise. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Impact of Exergame Use on User Health
- What is being tested?
- Xbox 360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- junior and senior undergraduate student
- senior graduate student
Who cannot join
- asthma
- high myopia
- anemia
- vertigo
- cardiopathy
- hypertension
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Exergame on User Health: A Randomized Controlled Trial
The purpose of this study is to examine whether exergame use can improve user health, in terms of physical fitness, self-rated mental health and physical health, and favorable attitude, strong intention, and actual behavior of future exercise. Moreover, this study also examines whether past exercise moderates the impact of exergame use on user health.
Read the 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.
- Conditions
- Impact of Exergame Use on User Health
- Being tested
- Xbox 360
- Keywords
- Exergame, user health, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xbox 360Device
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.
| Study group | Role | What they receive |
|---|---|---|
| exergame | Experimental | Participants were asked to use exergame (Xbox 360) half hour for three times per week in the 12-week study period. Receives: Device: Xbox 360 |
| control | No intervention | Participants were not asked to use exergames. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical fitness
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.
Measured: The beginning and the end of expected average of 12 weeks
Secondary outcomes (12)
Change in mental and physical health (12 weeks)
Self-rated mental and physical health, using the SF-36 scale.
Measured: The beginning and the end of expected average of 12 weeks
Change in attitude of future exercise (12 weeks)
Self-reported questionnaires assessing users' attitude toward future exercise between an expected average of 12 weeks since randomization.
Measured: The beginning and the end of expected average of 12 weeks
Change in intention of future exercise (12 weeks)
Self-reported questionnaires assessing users' intention to do exercise in the future between an expected average of 12 weeks since randomization.
Measured: The beginning and the end of expected average of 12 weeks
Change in behavior of future exercise (12 weeks)
Self-reported questionnaires assessing users' actual exercise behavior between an expected average of 12 weeks since randomization.
Measured: The beginning and the end of expected average of 12 weeks
Change in mental and physical health (8 weeks)
Self-rated mental and physical health, using the SF-36 scale.
Measured: The beginning and the end of expected average of 8 weeks
Change in attitude of future exercise (8 weeks)
Self-reported questionnaires assessing users' attitude toward future exercise between an expected average of 8 weeks since randomization.
Measured: The beginning and the end of expected average of 8 weeks
Change in intention of future exercise (8 weeks)
Self-reported questionnaires assessing users' intention to do exercise in the future between an expected average of 8 weeks since randomization.
Measured: The beginning and the end of expected average of 8 weeks
Change in behavior of future exercise (8 weeks)
Self-reported questionnaires assessing users' actual exercise behavior between an expected average of 8 weeks since randomization.
Measured: The beginning and the end of expected average of 8 weeks
Change in mental and physical health (4 weeks)
Self-rated mental and physical health, using the SF-36 scale.
Measured: The beginning and the end of expected average of 4 weeks
Change in attitude of future exercise (4 weeks)
Self-reported questionnaires assessing users' attitude toward future exercise between an expected average of 4 weeks since randomization.
Measured: The beginning and the end of expected average of 4 weeks
Change in intention of future exercise (4 weeks)
Self-reported questionnaires assessing users' intention to do exercise in the future between an expected average of 4 weeks since randomization.
Measured: The beginning and the end of expected average of 4 weeks
Change in behavior of future exercise (4 weeks)
Self-reported questionnaires assessing users' actual exercise behavior between an expected average of 4 weeks since randomization.
Measured: The beginning and the end of expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Exergame Use on User HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Ching-I Teng, Chang Gung University
- Investigators
- Ching-I Teng, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129023
- Sponsor's protocol ID
- CMRPD3D0021
- Status last verified
- Feb 2019
- First submitted
- 15 Apr 2014
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exergame on User Health: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02129023
- Acronym / sponsor ID
- CMRPD3D0021
- Conditions
- Impact of Exergame Use on User Health
- Keywords
- Exergame, user health, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- Jan 2014 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether exergame use can improve user health, in terms of physical fitness, self-rated mental health and physical health, and favorable attitude, strong intention, and actual behavior of future exercise. Moreover, this study also examines whether past exercise moderates the impact of exergame use on user health.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exergame | Experimental | Device: Xbox 360Participants were asked to use exergame (Xbox 360) half hour for three times per week in the 12-week study period. |
| control | No intervention | –Participants were not asked to use exergames. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- junior and senior undergraduate student
- senior graduate student
Key exclusion criteria (16 listed)
- asthma
- high myopia
- anemia
- vertigo
- cardiopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xbox 360For 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. | Device | exergame |
Primary outcome
Change in physical fitness
Time frame: The beginning and the end of expected average of 12 weeks
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.
12 secondary outcomes
Change in mental and physical health (12 weeks)
Time frame: The beginning and the end of expected average of 12 weeks
Change in attitude of future exercise (12 weeks)
Time frame: The beginning and the end of expected average of 12 weeks
Change in intention of future exercise (12 weeks)
Time frame: The beginning and the end of expected average of 12 weeks
Change in behavior of future exercise (12 weeks)
Time frame: The beginning and the end of expected average of 12 weeks
Change in mental and physical health (8 weeks)
Time frame: The beginning and the end of expected average of 8 weeks
Change in attitude of future exercise (8 weeks)
Time frame: The beginning and the end of expected average of 8 weeks
Change in intention of future exercise (8 weeks)
Time frame: The beginning and the end of expected average of 8 weeks
Change in behavior of future exercise (8 weeks)
Time frame: The beginning and the end of expected average of 8 weeks
Change in mental and physical health (4 weeks)
Time frame: The beginning and the end of expected average of 4 weeks
Change in attitude of future exercise (4 weeks)
Time frame: The beginning and the end of expected average of 4 weeks
Change in intention of future exercise (4 weeks)
Time frame: The beginning and the end of expected average of 4 weeks
Change in behavior of future exercise (4 weeks)
Time frame: The beginning and the end of expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-I Teng, PhD principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xbox 360 in people with Impact of Exergame Use on User Health, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical fitness (time frame: The beginning and the end of expected average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.