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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03663699
Other study ID # 2018/633
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 11, 2019
Est. completion date April 7, 2021

Study information

Verified date April 2021
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date April 7, 2021
Est. primary completion date April 7, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exergaming
free access to the exergaming platform PlayPulse for 24 weeks

Locations

Country Name City State
Norway Department of Circulation and Medical Imaging Trondheim

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary VO2max Maximal Aerobic Capacity 12 weeks
Primary VO2max Maximal Aerobic Capacity 24 weeks
Secondary Change in daily average energy expenditure 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
Secondary Change in daily time in sedentary activity (<3.0 metabolic equivalents =METs) 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
Secondary Change in daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs) 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
Secondary Change in daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs) 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
Secondary Change in daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs) 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
Secondary Change in daily average total physical activity duration 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
Secondary Change in daily average number of steps 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
Secondary Bioelectrical impedance Body composition assessed using bioelectrical impedance analysis (InBody 720) 12 and 24 weeks
Secondary systolic Blood Pressure 12 and 24 weeks
Secondary Diastolic Blood Pressure 12 and 24 weeks
Secondary Fasting circulating glucose, as blood marker of cardiometabolic health 24 weeks
Secondary Lipid profile, as blood marker of cardiometabolic health 24 weeks
Secondary Circulating insulin concentration, as blood marker of cardiometabolic health 24 weeks
Secondary HbA1c from blood samples 24 weeks
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