- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663699
Gaming and Training Combined to Help Adolescents Get More Physically Active
April 21, 2021 updated by: Norwegian University of Science and Technology
Increasing Physical Activity Among Adolescents With Motivational High-Intensity Training Through a Cutting-Edge Gaming Platform
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway, 7491
- Department of Circulation and Medical Imaging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Known cardiovascular disease
- Type I diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exergaming
24 week access to the exergaming platform PlayPulse
|
free access to the exergaming platform PlayPulse for 24 weeks
Other Names:
|
No Intervention: Control
Asked to continue with their normal daily routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2max
Time Frame: 12 weeks
|
Maximal Aerobic Capacity
|
12 weeks
|
VO2max
Time Frame: 24 weeks
|
Maximal Aerobic Capacity
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in daily average energy expenditure
Time Frame: Baseline, 12 and 24 weeks
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
|
Baseline, 12 and 24 weeks
|
Change in daily time in sedentary activity (<3.0 metabolic equivalents =METs)
Time Frame: Baseline, 12 and 24 weeks
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
|
Baseline, 12 and 24 weeks
|
Change in daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Time Frame: Baseline, 12 and 24 weeks
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
|
Baseline, 12 and 24 weeks
|
Change in daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs)
Time Frame: Baseline, 12 and 24 weeks
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
|
Baseline, 12 and 24 weeks
|
Change in daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Time Frame: Baseline, 12 and 24 weeks
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
|
Baseline, 12 and 24 weeks
|
Change in daily average total physical activity duration
Time Frame: Baseline, 12 and 24 weeks
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
|
Baseline, 12 and 24 weeks
|
Change in daily average number of steps
Time Frame: Baseline, 12 and 24 weeks
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 12 weeks and 24 weeks.
|
Baseline, 12 and 24 weeks
|
Bioelectrical impedance
Time Frame: 12 and 24 weeks
|
Body composition assessed using bioelectrical impedance analysis (InBody 720)
|
12 and 24 weeks
|
systolic Blood Pressure
Time Frame: 12 and 24 weeks
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12 and 24 weeks
|
|
Diastolic Blood Pressure
Time Frame: 12 and 24 weeks
|
12 and 24 weeks
|
|
Fasting circulating glucose, as blood marker of cardiometabolic health
Time Frame: 24 weeks
|
24 weeks
|
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Lipid profile, as blood marker of cardiometabolic health
Time Frame: 24 weeks
|
24 weeks
|
|
Circulating insulin concentration, as blood marker of cardiometabolic health
Time Frame: 24 weeks
|
24 weeks
|
|
HbA1c from blood samples
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2019
Primary Completion (Actual)
April 7, 2021
Study Completion (Actual)
April 7, 2021
Study Registration Dates
First Submitted
September 6, 2018
First Submitted That Met QC Criteria
September 6, 2018
First Posted (Actual)
September 10, 2018
Study Record Updates
Last Update Posted (Actual)
April 23, 2021
Last Update Submitted That Met QC Criteria
April 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018/633
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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