Can a 6-minute Walking or Resting Break Improve Executive... | NCT04674436

Studies
Can a 6-minute Walking or Resting Break Improve Executive Function in Gamers.

NCT04674436

Sponsor

New York Institute of Technology

Status

Completed

Last Update Posted

Jan 18, 2022Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Sedentary Behavior

Interventions

Walking

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2020Actual

Primary Completion Date

Feb 24, 2021Actual

Completion Date

Feb 24, 2021Actual

First Submitted Date

Dec 14, 2020

First Submission Date that Met QC Criteria

Dec 14, 2020

First Posted Date

Dec 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2022

Last Update Posted Date

Jan 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joanne DiFrancisco-Donoghue, Associate Professor, New York Institute of TechnologyPrincipal Investigator

Lead Sponsor

New York Institute of TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will ask ranked first person shooters in esports to participate on three separate days from their home computer to test executive function prior tp play and following two hours of play. One testing day will incorporate a 6 minute walk break, another day will incorporate a 6 minute rest break, and the third day will be continuous play. Executive tests will be administered electronically prior to game play and post game play.

Detailed Description

A ranked first person shooter player will play for two hours each session, and on separate days will take a 6 minute walking break or a 6 minute resting break within 2 hours of game play. This study is virtual and you may play from your regular home gaming computer. The third day will be continuous play.

The study will take place on 3 separate days. Preferably 2 -3 days in -between testing days.

Participants will sign an electronic consent form to sign and agree to participate. It will explain the study in detail.
Participants will then be asked to take two executive function tests online. These test will be sent electronically through email. This is for practice. These tests take approximately 6-7 minutes.
We will schedule one day where the participant will play a first -person shooter game. Prior to playing the participants will be take to take the two executive function tests.
On one day the participant will be asked to stop after the first hour (they will be allowed to finish the test) they will either walk for 6 minutes near their computer or rest for 6 minutes. Participants will be contacted through cell phones or discord.
Game play will resume normally for another hour. When that hour is completed the participant will be asked to take the two online tests again.
This will be 2 days. The third day the participant will take the online tests and play continuous for 2 hours with no break and then repeat the online tests.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
6 minute walking break	Experimental	Participants will walk casually for 6 minutes following one hour of game play, then continue play for one more hour.	Behavioral: Walking
6 minute rest break	Experimental	Participants will rest supine for 6 minutes following one hour of game play, then continue play for one more hour.	Behavioral: Walking
Continuous play	No Intervention	Participants will play continuous for 2 hours.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Walking	Behavioral	6 minute casual walk	6 minute rest break 6 minute walking break

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Executive Function	The primary purpose of this study is to evaluate executive function changes following a 6-minute walking break to a 6 minute resting break in competitive esport players following 60 minutes of prolonged play	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:1. Women or men 18-25 years of age 2. Play first-person shooter games with a ranking of "gold" or higher (self reported).

Exclusion Criteria:1. Any participants that do not have a competitive ranking 2. Any participants that are colorblind (self reported) 3. Any participants that have sustained previous hand injuries within the last year, or suffer from chronic wrist pain.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joanne Donoghue	New York Institute of Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Institute of Technology College of Osteopathic Medicine		Old Westbury	New York	11568	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057185	Sedentary Behavior

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016138	Walking

Ancestor Terms

ID	Term
D008124	Locomotion
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided