Trial Outcomes & Findings for An Evaluation of the Energy Expenditure From Wii Fit Games (NCT NCT01561716)

NCT ID: NCT01561716

Last Updated: 2015-10-01

Results Overview

Energy expenditure is measured using continuous, computerized open-circuit indirect calorimetry (oxygen consumption and carbon dioxide production) and converted to metabolic equivalents (METs).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

30 min continuous monitoring at rest and during each physical activity

Results posted on

2015-10-01

Participant Flow

Thirty young healthy volunteers were enrolled in this randomized, crossover trial to examine the energy expenditure associated with Wii Fit and treadmill walking/running compared to sedentary resting between September 2009 and April 2010. Recruitment flyers were placed in the University of Rochester, Strong Memorial Hospital.

Each participant was assigned to a crossover sequence based on a computer generated randomization schedule using SAS 9.2. A washout period of at least 24 hours separated each study session.

Participant milestones

Participant milestones
Measure
Crossover Sequence 1
Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
Crossover Sequence 2
Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
Crossover Sequence 3
Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
Crossover Sequence 4
Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
Crossover Sequence 5
Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
Crossover Sequence 6
Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
Overall Study
STARTED
5
5
5
5
5
5
Overall Study
COMPLETED
5
5
5
5
5
5
Overall Study
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Evaluation of the Energy Expenditure From Wii Fit Games

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Crossover Sequence 1
n=5 Participants
Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
Crossover Sequence 2
n=5 Participants
Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
Crossover Sequence 3
n=5 Participants
Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
Crossover Sequence 4
n=5 Participants
Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
Crossover Sequence 5
n=5 Participants
Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
Crossover Sequence 6
n=5 Participants
Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
Total
n=30 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
5 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
5 Participants
n=21 Participants
5 Participants
n=10 Participants
30 Participants
n=115 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
Age, Continuous
28.6 years
STANDARD_DEVIATION 4.4 • n=5 Participants
27.8 years
STANDARD_DEVIATION 4.0 • n=7 Participants
26.4 years
STANDARD_DEVIATION 2.4 • n=5 Participants
30.1 years
STANDARD_DEVIATION 2.4 • n=4 Participants
28.9 years
STANDARD_DEVIATION 2.8 • n=21 Participants
27.7 years
STANDARD_DEVIATION 3.7 • n=10 Participants
28.2 years
STANDARD_DEVIATION 3.3 • n=115 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
5 Participants
n=10 Participants
21 Participants
n=115 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
0 Participants
n=10 Participants
9 Participants
n=115 Participants
Region of Enrollment
United States
5 participants
n=5 Participants
5 participants
n=7 Participants
5 participants
n=5 Participants
5 participants
n=4 Participants
5 participants
n=21 Participants
5 participants
n=10 Participants
30 participants
n=115 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
At Rest
n=30 Participants
Energy expenditure at rest
Wii Fit Free Run
n=30 Participants
Energy expenditure during 30 min Wii Fit Free Run
Wii Fit Super Hula Hoop
n=30 Participants
Energy expenditure during 10 min Wii Fit Super Hula Hoop
Wii Fit Advanced Steps
n=30 Participants
Energy expenditure during 10 min Wii Fit Advanced Steps
Wii Fit Rhythm Boxing
n=30 Participants
Energy expenditure during 10 min Wii Fit Rhythm Boxing
Treadmill Running/Walking
n=30 Participants
Energy expenditure during 30 min treadmill running/walking
Energy Expenditure
0.9 METs
Standard Deviation 0.1
5.0 METs
Standard Deviation 1.4
3.9 METs
Standard Deviation 1.3
3.8 METs
Standard Deviation 2.0
4.1 METs
Standard Deviation 0.9
8.0 METs
Standard Deviation 2.2

Adverse Events

Crossover Sequence 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Crossover Sequence 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Crossover Sequence 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Crossover Sequence 4

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Crossover Sequence 5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Crossover Sequence 6

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Isabel D Fernandez

University of Rochester

Phone: 585-275-9554

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place