NCT03663699

Brief Summary

The purpose of this study is to investigate if playing a newly developed videogame that requires physical activity (e.g. exergame), leads to increased physical activity and health benefits in children and adolescents who do not regularly participate in endurance training. Health benefits will be expressed in physical fitness (maximal oxygen consumption), blood markers of a healthy heart, body composition and objectively measured physical activity. Gaming frequency of the participants will be registered throughout the 24 week intervention period.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

September 6, 2018

Last Update Submit

April 21, 2021

Conditions

Keywords

Exercise TherapyPhysical FitnessGames, RecreationalChildrenAdolescentsHealthy LifestyleExercise Test

Outcome Measures

Primary Outcomes (2)

  • VO2max

    Maximal Aerobic Capacity

    12 weeks

  • VO2max

    Maximal Aerobic Capacity

    24 weeks

Secondary Outcomes (14)

  • Change in daily average energy expenditure

    Baseline, 12 and 24 weeks

  • Change in daily time in sedentary activity (<3.0 metabolic equivalents =METs)

    Baseline, 12 and 24 weeks

  • Change in daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)

    Baseline, 12 and 24 weeks

  • Change in daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs)

    Baseline, 12 and 24 weeks

  • Change in daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)

    Baseline, 12 and 24 weeks

  • +9 more secondary outcomes

Study Arms (2)

Exergaming

EXPERIMENTAL

24 week access to the exergaming platform PlayPulse

Behavioral: Exergaming

Control

NO INTERVENTION

Asked to continue with their normal daily routine

Interventions

ExergamingBEHAVIORAL

free access to the exergaming platform PlayPulse for 24 weeks

Also known as: PlayPulse
Exergaming

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Not regularly participating in endurance training
  • Sedentary (\<60 mins daily moderate/vigorous intensity physical activity)
  • Play video games \> 10 hours/week (self-reported)
  • Able to ride a bike for up to 60 minutes

You may not qualify if:

  • Known cardiovascular disease
  • Type I diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Øystein Risa, PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 10, 2018

Study Start

February 11, 2019

Primary Completion

April 7, 2021

Study Completion

April 7, 2021

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations