Healthy Young AdultsNCT01561716
An Evaluation of the Energy Expenditure From Wii Fit Games
A study testing Wii Fit in people with Healthy Young Adults, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to provide energy expenditure data on Wii Fit / Wii Fit Plus games as compared with resting and treadmill walking/running. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Wii Fit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No chronic disease by self-report (e.g. cardiovascular, renal, hepatic, neurodegenerative, neoplastic, metabolic {diabetes}, hypertension).
- Between the ages of 20-35.
- Normal BMI (BMI between 18.5 and 24.9).
- Not a current nicotine user.
- Demonstrates capacity for giving informed consent. Willing to participate by providing informed consent and committing to complete the study.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Wii Fit / Wii Fit Plus Good Enough? A Comparison of the Energy Expenditure From Interactive Physical Activity Promoting Technology to Walking and Running
The purpose of this study is to provide energy expenditure data on Wii Fit / Wii Fit Plus games as compared with resting and treadmill walking/running.
Read the detailed description
Increasing physical activity and, consequently, increasing energy expenditure and reducing obesity are among the highest public health priorities in the U.S. because physical inactivity negatively affects a wide variety of medical conditions (e.g., metabolic syndromes, cardiovascular disease). Research has shown that a major contributor to physical inactivity is the sedentary behavior induced by increased use of computer and video games. However, some of the newer generations of game consoles such as the Nintendo Wii market their product for its physical activity promoting features. Nintendo's recent release of Wii Fit / Wii Fit Plus uses a balance board and is the first game in which whole-body movements closely mirror that of the actual activity. As the use of these gaming systems may be more enjoyable modes of promoting physical activity than the traditional treadmill exercise, respondents may in turn exercise more regularly and for longer periods of time. To the best of the investigators' knowledge, no studies exist that demonstrate the energy expenditure of the Wii Fit / Wii Fit Plus among adults, or the Wii Fit / Wii Fit Plus compared to other forms of aerobic exercise such as walking and running. This study will provide preliminary data for future external grant applications comparing the energy expenditure of different physical activity conditions employing cutting-edge interactive physical activity promoting technology among adults. The potential contributions of the Wii Fit / Wii Fit Plus to promote healthy behaviors by being an alternative form of physical activity may be particularly informative for people who are unable to meet the national public health recommendations due to personal, health, safety or environmental concerns.
- Conditions
- Healthy Young Adults
- Being tested
- Wii Fit
- Keywords
- video games, energy expenditure, physical activity, exercise physiology
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii FitDevice
This is a randomized, crossover study to evaluate the energy expenditure associated with Wii Fit games. After the baseline resting energy expenditure assessment, each participant complete the following physical activities on separate days in a random order, (1) 30-minute Wii Fit Aerobics Free Run, (2) 3 bouts of Wii Fit Aerobics (Advanced Step, Super Hula Hoop, and Rhythm Boxing in a random order) each lasting 10 minutes, and (3) 30-minute treadmill running/walking.
| Study group | Role | What they receive |
|---|---|---|
| Crossover sequence 1 | Experimental | Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill Receives: Device: Wii Fit |
| Crossover sequence 2 | Experimental | Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts Receives: Device: Wii Fit |
| Crossover sequence 3 | Experimental | Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill Receives: Device: Wii Fit |
| Crossover sequence 4 | Experimental | Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run Receives: Device: Wii Fit |
| Crossover sequence 5 | Experimental | Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts Receives: Device: Wii Fit |
| Crossover sequence 6 | Experimental | Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run Receives: Device: Wii Fit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Expenditure
Energy expenditure is measured using continuous, computerized open-circuit indirect calorimetry (oxygen consumption and carbon dioxide production) and converted to metabolic equivalents (METs).
Measured: 30 min continuous monitoring at rest and during each physical activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Young AdultsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Xian, University of Rochester
- Investigators
- Isabel D Fernandez, MD, PhD, MPH, Study chair, University of RochesterYing Xian, MD, PhD, Principal investigator, Duke Clinical Research InstituteLisa Kakinami, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561716
- Sponsor's protocol ID
- UL1RR024160/5-23087
- Other IDs
- UL1RR024160
- Status last verified
- Sep 2015
- First submitted
- 14 Mar 2012
- Last updated
- 1 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Wii Fit / Wii Fit Plus Good Enough? A Comparison of the Energy Expenditure From Interactive Physical Activity Promoting Technology to Walking and Running
- ClinicalTrials.gov ID
- NCT01561716
- Acronym / sponsor ID
- UL1RR024160/5-23087
- Conditions
- Healthy Young Adults
- Keywords
- video games, energy expenditure, physical activity, exercise physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Posted 25 Apr 2012
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 provide energy expenditure data on Wii Fit / Wii Fit Plus games as compared with resting and treadmill walking/running.
Detailed description
Increasing physical activity and, consequently, increasing energy expenditure and reducing obesity are among the highest public health priorities in the U.S. because physical inactivity negatively affects a wide variety of medical conditions (e.g., metabolic syndromes, cardiovascular disease). Research has shown that a major contributor to physical inactivity is the sedentary behavior induced by increased use of computer and video games. However, some of the newer generations of game consoles such as the Nintendo Wii market their product for its physical activity promoting features. Nintendo's recent release of Wii Fit / Wii Fit Plus uses a balance board and is the first game in which whole-body movements closely mirror that of the actual activity. As the use of these gaming systems may be more enjoyable modes of promoting physical activity than the traditional treadmill exercise, respondents may in turn exercise more regularly and for longer periods of time. To the best of the investigators' knowledge, no studies exist that demonstrate the energy expenditure of the Wii Fit / Wii Fit Plus among adults, or the Wii Fit / Wii Fit Plus compared to other forms of aerobic exercise such as walking and running. This study will provide preliminary data for future external grant applications comparing the energy expenditure of different physical activity conditions employing cutting-edge interactive physical activity promoting technology among adults. The potential contributions of the Wii Fit / Wii Fit Plus to promote healthy behaviors by being an alternative form of physical activity may be particularly informative for people who are unable to meet the national public health recommendations due to personal, health, safety or environmental concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Crossover sequence 1 | Experimental | Device: Wii FitResting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill |
| Crossover sequence 2 | Experimental | Device: Wii FitResting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts |
| Crossover sequence 3 | Experimental | Device: Wii FitResting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill |
| Crossover sequence 4 | Experimental | Device: Wii FitResting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run |
| Crossover sequence 5 | Experimental | Device: Wii FitResting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts |
| Crossover sequence 6 | Experimental | Device: Wii FitResting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- No chronic disease by self-report (e.g. cardiovascular, renal, hepatic, neurodegenerative, neoplastic, metabolic {diabetes}, hypertension).
- Between the ages of 20-35.
- Normal BMI (BMI between 18.5 and 24.9).
- Not a current nicotine user.
- Demonstrates capacity for giving informed consent. Willing to participate by providing informed consent and committing to complete the study.
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Wii FitThis is a randomized, crossover study to evaluate the energy expenditure associated with Wii Fit games. After the baseline resting energy expenditure assessment, each participant complete the following physical activities on separate days in a random order, (1) 30-minute Wii Fit Aerobics Free Run, (2) 3 bouts of Wii Fit Aerobics (Advanced Step, Super Hula Hoop, and Rhythm Boxing in a random order) each lasting 10 minutes, and (3) 30-minute treadmill running/walking. | Device | Crossover sequence 1, Crossover sequence 2, Crossover sequence 3, Crossover sequence 4, Crossover sequence 5, Crossover sequence 6 |
Primary outcome
Energy Expenditure
Time frame: 30 min continuous monitoring at rest and during each physical activity
Energy expenditure is measured using continuous, computerized open-circuit indirect calorimetry (oxygen consumption and carbon dioxide production) and converted to metabolic equivalents (METs).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Healthy Volunteers
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.
Isabel D Fernandez, MD, PhD, MPH study chair
University of Rochester
Ying Xian, MD, PhD principal investigator
Duke Clinical Research Institute
Lisa Kakinami, PhD principal investigator
McGill 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 Wii Fit in people with Healthy Young Adults, run by University of Rochester at 1 site in United States.
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 5 inclusion and 1 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 1 Oct 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Energy Expenditure (time frame: 30 min continuous monitoring at rest and during each physical activity). 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 1 Oct 2015.