NCT02437097

Brief Summary

Many studies have examined the effects of aerobic exercise and playing video games effects on cognitive performance, which results of which have shown to increase cognitive performance. Presently, there is limited research regarding the effects of the combination of gaming and exercise on cognitive performance. The purpose of our study is to investigate the effects of playing video games, aerobic exercise, and a combination of gaming and aerobic exercise on cognitive performance. Forty healthy subjects, males and females (18-30 years old) who perform moderate exercise at least two times a week will comprise our sample. The study will be a randomized clinical trial with four independent variables: playing video games, aerobic exercise, a combination of simultaneous gaming and aerobic exercise and a control condition. Aerobic exercise will be performed at an intensity of 60 to 70% of maximum heart rate on a Monarch Lower Body Ergometer. Brain Age Game: Train Your Brain in Minutes a Day! will be played on Nintendo 3DS. Executive function will be measured using the Stroop test and Trails B pre and posttest. Analysis of variance for Stroop test and Trails B will be used. In the event of significant F statistics, a post hoc test analysis will be used. The investigators hypothesize a combination of aerobic exercise and simultaneous gaming will produce the greatest increase in cognitive performance. Furthermore, these beneficial changes can be utilized in rehabilitation protocols designed to improve cognitive functioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

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

First Submitted

Initial submission to the registry

May 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

May 5, 2015

Last Update Submit

July 9, 2016

Conditions

Cognitive Performance in Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • The Stroop test

    : the subject will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning).

    10 minutes

  • The Trails B test

    : the subject is instructed to connect a set of 25 dots as fast as possible while maintaining accuracy. This test provides information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning.

    10 minutes

Study Arms (4)

Aerobic Exercise

EXPERIMENTAL

Participants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 - their age. The aerobic exercise will utilize a Monarch 818E Monarch Lower Body Ergometer (Monark Exercise, Stockholm, Sweden). Participant's heart rate will be monitored using Polar heart rate monitor.

Other: Aerobic exercise

Video Gaming

EXPERIMENTAL

Participants will play Brain Age: Train Your Brain in Minutes a Day! on Nintendo 3DS for 30 minutes in a seated resting position.

Other: Video Gaming

Aerobic Exercise and Video Gaming

EXPERIMENTAL

Participants will perform 30 minutes of cycling at an intensity of 60 to 70% of maximum heart rate based on 220 minus their age on a Monarch ergometer while playing Brain Age: Train Your Brain in Minutes a Day! on a Nintendo 3DS. Participant's heart rate will be monitored using Polar heart rate.

Other: Aerobic exercise and Video Gaming

Control

PLACEBO COMPARATOR

Participants will sit quietly for 30 minutes

Other: Control

Interventions

Aerobic exerciseOTHER

The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.

Aerobic Exercise
Video GamingOTHER

The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.

Video Gaming
Aerobic exercise and Video GamingOTHER

The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.

Aerobic Exercise and Video Gaming
ControlOTHER

The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range: 18-30 years
  • Good overall health
  • Exercise at least two days/week

You may not qualify if:

  • Any cardiopulmonary conditions including asthma within the last 6 months.
  • Any major musculoskeletal injuries (i.e. torn ligaments, bone fractures, etc.) over the last 6 months.
  • Any other health issues that would interfere with a subject's safety during exercise.
  • Any auditory/vestibular impairments.
  • Uncorrected visual problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11568, United States

Location

Related Publications (5)

  • O'Leary KC, Pontifex MB, Scudder MR, Brown ML, Hillman CH. The effects of single bouts of aerobic exercise, exergaming, and videogame play on cognitive control. Clin Neurophysiol. 2011 Aug;122(8):1518-25. doi: 10.1016/j.clinph.2011.01.049. Epub 2011 Feb 24.

    PMID: 21353635BACKGROUND

  • Byun K, Hyodo K, Suwabe K, Ochi G, Sakairi Y, Kato M, Dan I, Soya H. Positive effect of acute mild exercise on executive function via arousal-related prefrontal activations: an fNIRS study. Neuroimage. 2014 Sep;98:336-45. doi: 10.1016/j.neuroimage.2014.04.067. Epub 2014 May 2.

    PMID: 24799137BACKGROUND

  • Chang YK, Chu CH, Wang CC, Song TF, Wei GX. Effect of acute exercise and cardiovascular fitness on cognitive function: an event-related cortical desynchronization study. Psychophysiology. 2015 Mar;52(3):342-51. doi: 10.1111/psyp.12364. Epub 2014 Oct 13.

    PMID: 25308605BACKGROUND

  • Yanagisawa H, Dan I, Tsuzuki D, Kato M, Okamoto M, Kyutoku Y, Soya H. Acute moderate exercise elicits increased dorsolateral prefrontal activation and improves cognitive performance with Stroop test. Neuroimage. 2010 May 1;50(4):1702-10. doi: 10.1016/j.neuroimage.2009.12.023. Epub 2009 Dec 16.

    PMID: 20006719BACKGROUND

  • Nouchi R, Taki Y, Takeuchi H, Hashizume H, Nozawa T, Kambara T, Sekiguchi A, Miyauchi CM, Kotozaki Y, Nouchi H, Kawashima R. Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial. PLoS One. 2013;8(2):e55518. doi: 10.1371/journal.pone.0055518. Epub 2013 Feb 6.

    PMID: 23405164BACKGROUND

MeSH Terms

Interventions

ExerciseExergaming

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physical Therapy

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 7, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

US(1)