- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513380
Can Gaming Get You Fit? A High-Intensity Exergaming Intervention in Adults
December 9, 2019 updated by: Norwegian University of Science and Technology
Motivational High Intensity Training Through a Cutting-edge Gaming Platform. A Randomised, Controlled Trial
The purpose of this project is to assess if playing a newly developed videogame that require physical activity (e.g.
exergame) can lead to health benefits.
The project will include 50 adult participants that are not particularly physically active.
They will be randomized into two groups where one group will be given free access to the exergame for 6 months.
The physical fitness (maximal oxygen consumption), blood markers of cardiometabolic health and body composition of the subjects will be tested before, mid-ways and after the intervention period.
Also, the participants gaming frequency will be registered throughout the 6-month period.
Aim of this study is to investigate if access to this game can provide health benefits for individuals who are not motivated to take part in regular physical activity.
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
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
-
-
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sedentary (<150 mins of moderate intensity physical activity/week)
- Able to ride a bike for up to 60 minutes
Exclusion Criteria:
- Known cardiovascular disease
- Taking beta-blockers or anti-arrhythmic drugs
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
free access to the exergame PedalTanks
|
free access to the exergame PedalTanks during 6 months
Other Names:
|
|
No Intervention: Control
recommended to continue with their normal daily routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
VO2max (Maximal Aerobic Capacity)
Time Frame: 3 months
|
3 months
|
|
VO2max (Maximal Aerobic Capacity)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily average energy expenditure
Time Frame: 3 and 6 months
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
|
3 and 6 months
|
|
Daily average number of steps
Time Frame: 3 and 6 months
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
|
3 and 6 months
|
|
Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
Time Frame: 3 and 6 months
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
|
3 and 6 months
|
|
Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Time Frame: 3 and 6 months
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
|
3 and 6 months
|
|
Daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs)
Time Frame: 3 and 6 months
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
|
3 and 6 months
|
|
Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Time Frame: 3 and 6 months
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
|
3 and 6 months
|
|
Daily average total physical activity duration
Time Frame: 3 and 6 months
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
|
3 and 6 months
|
|
Bioelectrical impedance
Time Frame: 3 and 6 months
|
Body composition assessed using bioelectrical impedance analysis (InBody 720)
|
3 and 6 months
|
|
Blood Pressure
Time Frame: 3 and 6 months
|
3 and 6 months
|
|
|
Fasting circulating glucose, as blood marker of cardiometabolic health
Time Frame: 6 months
|
6 months
|
|
|
Lipid profile, as blood marker of cardiometabolic health
Time Frame: 6 months
|
6 months
|
|
|
Circulating insulin concentration, as blood marker of cardiometabolic health
Time Frame: 6 months
|
6 months
|
|
|
glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
May 25, 2018
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 30, 2018
First Posted (Actual)
May 1, 2018
Study Record Updates
Last Update Posted (Actual)
December 11, 2019
Last Update Submitted That Met QC Criteria
December 9, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2017/1501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.