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Gaming and Training Combined to Help Adolescents Get More Physically Active

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663699
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Exergaming Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Physical Activity Among Adolescents With Motivational High-Intensity Training Through a Cutting-Edge Gaming Platform
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exergaming
24 week access to the exergaming platform PlayPulse
Behavioral: Exergaming
free access to the exergaming platform PlayPulse for 24 weeks
Other Name: PlayPulse

No Intervention: Control
Asked to continue with their normal daily routine



Primary Outcome Measures :
  1. VO2max [ Time Frame: 12 weeks ]
    Maximal Aerobic Capacity

  2. VO2max [ Time Frame: 24 weeks ]
    Maximal Aerobic Capacity


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Bioelectrical impedance [ Time Frame: 12 and 24 weeks ]
    Body composition assessed using bioelectrical impedance analysis (InBody 720)

  9. systolic Blood Pressure [ Time Frame: 12 and 24 weeks ]
  10. Diastolic Blood Pressure [ Time Frame: 12 and 24 weeks ]
  11. Fasting circulating glucose, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  12. Lipid profile, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  13. Circulating insulin concentration, as blood marker of cardiometabolic health [ Time Frame: 24 weeks ]
  14. HbA1c from blood samples [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663699


Contacts
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Contact: Trine Moholdt, PhD +4797098594 trine.moholdt@ntnu.no
Contact: Jonathan Berg, MSc +4745205565 jonathan.berg@ntnu.no

Locations
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Norway
Department of Circulation and Medical Imaging Recruiting
Trondheim, Norway, 7491
Contact: Jonathan Berg, MSc    +47 45205565    jonathan.berg@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Study Director: Øystein Risa, PhD Norwegian University of Science and Technology
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03663699    
Other Study ID Numbers: 2018/633
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Exercise Therapy
Physical Fitness
Games, Recreational
Children
Adolescents
Healthy Lifestyle
Exercise Test