NCT01561716

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
1 month until next milestone

Results Posted

Study results publicly available

April 25, 2012

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

March 14, 2012

Results QC Date

March 29, 2012

Last Update Submit

September 16, 2015

Conditions

Healthy Young Adults

Keywords

video gamesenergy expenditurephysical activityexercise physiology

Outcome Measures

Primary Outcomes (1)

  • 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).

    30 min continuous monitoring at rest and during each physical activity

Study Arms (6)

Crossover sequence 1

EXPERIMENTAL

Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill

Device: Wii Fit

Crossover sequence 2

EXPERIMENTAL

Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts

Device: Wii Fit

Crossover sequence 3

EXPERIMENTAL

Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill

Device: Wii Fit

Crossover sequence 4

EXPERIMENTAL

Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run

Device: Wii Fit

Crossover sequence 5

EXPERIMENTAL

Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts

Device: Wii Fit

Crossover sequence 6

EXPERIMENTAL

Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run

Device: Wii Fit

Interventions

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.

Crossover sequence 1Crossover sequence 2Crossover sequence 3Crossover sequence 4Crossover sequence 5Crossover sequence 6

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

The lab staffs that administrated the tests were not blinded to the order of the randomization, nor were they blinded to the results of the test. Thus, our study is subjected to observer and measurement biases.

Results Point of Contact

Title
Dr. Isabel D Fernandez
Organization
University of Rochester
Diana_Fernandez@URMC.Rochester.edu
585-275-9554

Study Officials

  • Isabel D Fernandez, MD, PhD, MPH

    University of Rochester

    STUDY CHAIR

  • Ying Xian, MD, PhD

    Duke Clinical Research Institute

    PRINCIPAL INVESTIGATOR

  • Lisa Kakinami, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 23, 2012

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 1, 2015

Results First Posted

April 25, 2012

Record last verified: 2015-09

Locations

US(1)