NCT04015583

Brief Summary

Background: Recent studies indicate that exercise-related games can improve executive function, attention processing, and visuospatial skills. Objective: This study investigates whether exercise with exergaming can improve the executive function in patients with metabolic syndrome (MetS). Methods: Twenty-two MetS patients were recruited and randomly assigned to the exergaming group (EXG) and treadmill exercise group (TEG). The reaction time (RT) and electrophysiological signal from the frontal (Fz), central (Cz), and parietal (Pz) cortex were collected during a Stroop task after 12 weeks' exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

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

April 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

June 27, 2019

Last Update Submit

July 9, 2019

Conditions

Keywords

exergamingexecutive functionsevent-related potentialmetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Change of amplitude of N200 as measured by Electroencephalographic

    N200 negativity (200\~350 ms post-stimulus) is an event-related potential, which indicates attentional capacity that is usually induced before motion response control and is related to the cognitive processes of stimulus recognition and differentiationcontrol) are a set of cognitive processes that are necessary for the cognitive control of behavior

    Change from Baseline N200 at 3 months

Secondary Outcomes (1)

  • Change of amplitude of P300 as measured by Electroencephalographic

    Change from Baseline P300 at 3 months

Study Arms (2)

exergaming group

EXPERIMENTAL

The exergaming group (EXG) performed exercise using Exerheart® devices (D\&J Humancare, Busan, South Korea) composed of a running/jumping mat \[730(W) × 730(D) × 130(H)\] and a tablet PC on a stand (can be adjusted to any height between 70 and 155 cm) (Supplemental Figure 1A). Exerheart® is an exergaming developed for in-situ running along with the video game called "Alchemist's Treasure" (D\&J Humancare, Busan, South Korea). To play this game, the subject has to run or jump on a spot on the mat to move a virtual avatar on the screen of the tablet PC to the front, back, left, and right along with music. The subject can control the speed of avatar movement by running or jumping speed on the mat.

Behavioral: exergaming group

treadmill exercise group

ACTIVE COMPARATOR

The treadmill exercise group (TEG) performed exercise using commercial treadmills (MOTUS, Gyeonggi-do, South Korea). Each subject walked or ran on the treadmill at a comfortable speed.

Behavioral: exergaming group

Interventions

Exergame is 'exercise + game'. Treadmill exercise is traiditional aerobic exercise

Also known as: treadmill exercise group
exergaming grouptreadmill exercise group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metabolic syndrome patients(NCEP-ATP III)

You may not qualify if:

  • Neurologic disorders
  • Malignant disease
  • Renal failure
  • Chronic obstructive pulmonary disease
  • Valvular heart disease
  • Acute coronary syndrome
  • Myocardial infarction
  • Musculoskeletal patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Related Publications (2)

  • Baranowski T, Abdelsamad D, Baranowski J, O'Connor TM, Thompson D, Barnett A, Cerin E, Chen TA. Impact of an active video game on healthy children's physical activity. Pediatrics. 2012 Mar;129(3):e636-42. doi: 10.1542/peds.2011-2050. Epub 2012 Feb 27.

    PMID: 22371457BACKGROUND
  • Wu S, Jo EA, Ji H, Kim KH, Park JJ, Kim BH, Cho KI. Exergaming Improves Executive Functions in Patients With Metabolic Syndrome: Randomized Controlled Trial. JMIR Serious Games. 2019 Jul 31;7(3):e13575. doi: 10.2196/13575.

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kyoungim Cho, MD, PhD

    Kosin University Gospel Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: exergaming group and treadmill exercise group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 11, 2019

Study Start

April 1, 2017

Primary Completion

December 31, 2017

Study Completion

March 31, 2018

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations