Sedentary LifestyleNCT03663699
Gaming and Training Combined to Help Adolescents Get More Physically Active
A study testing Exergaming in people with Sedentary Lifestyle, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNorway
- Study dates
- 11 Feb 2019to 7 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Known cardiovascular disease
- Type I diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- Exergaming
- Keywords
- Exercise Therapy, Physical Fitness, Games, Recreational, Children, Adolescents, Healthy Lifestyle, Exercise Test
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingBehavioural
Also called PlayPulse
free access to the exergaming platform PlayPulse for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exergaming | Experimental | 24 week access to the exergaming platform PlayPulse Receives: Behavioral: Exergaming |
| Control | No intervention | Asked to continue with their normal daily routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Maximal Aerobic Capacity
Measured: 12 weeks
VO2max
Maximal Aerobic Capacity
Measured: 24 weeks
Secondary outcomes (14)
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.
Measured: Baseline, 12 and 24 weeks
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.
Measured: Baseline, 12 and 24 weeks
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.
Measured: Baseline, 12 and 24 weeks
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.
Measured: Baseline, 12 and 24 weeks
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.
Measured: Baseline, 12 and 24 weeks
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.
Measured: Baseline, 12 and 24 weeks
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.
Measured: Baseline, 12 and 24 weeks
Bioelectrical impedance
Body composition assessed using bioelectrical impedance analysis (InBody 720)
Measured: 12 and 24 weeks
systolic Blood Pressure
Measured: 12 and 24 weeks
Diastolic Blood Pressure
Measured: 12 and 24 weeks
Fasting circulating glucose, as blood marker of cardiometabolic health
Measured: 24 weeks
Lipid profile, as blood marker of cardiometabolic health
Measured: 24 weeks
Circulating insulin concentration, as blood marker of cardiometabolic health
Measured: 24 weeks
HbA1c from blood samples
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start11 Feb 2019
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Why it stopped: grunnet COVID-19 pandemien då vi haft hög drop-out og vanskelig att rekruttere
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663699
- Sponsor's protocol ID
- 2018/633
- Status last verified
- Apr 2021
- First submitted
- 6 Sep 2018
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berg J, Wang AI, Madssen E, Roe L, Moholdt T. Effects of providing access to a cycling exergaming platform on cardiorespiratory fitness and cardiometabolic health in adolescents: a randomised, controlled trial. Sci Rep. 2026 May 8;16(1):21098. doi: 10.1038/s41598-026-48327-3.
PubMed 42103774
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity Among Adolescents With Motivational High-Intensity Training Through a Cutting-Edge Gaming Platform
- ClinicalTrials.gov ID
- NCT03663699
- Acronym / sponsor ID
- 2018/633
- Conditions
- Sedentary Lifestyle
- Keywords
- Exercise Therapy, Physical Fitness, Games, Recreational, Children, Adolescents, Healthy Lifestyle, Exercise Test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: grunnet COVID-19 pandemien då vi haft hög drop-out og vanskelig att rekruttere
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming | Experimental | Behavioral: Exergaming24 week access to the exergaming platform PlayPulse |
| Control | No intervention | –Asked to continue with their normal daily routine |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Known cardiovascular disease
- Type I diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergamingAlso: PlayPulsefree access to the exergaming platform PlayPulse for 24 weeks | Behavioural | Exergaming |
Primary outcome
VO2max
Time frame: 12 weeks
Maximal Aerobic Capacity
VO2max
Time frame: 24 weeks
Maximal Aerobic Capacity
14 secondary outcomes
Change in daily average energy expenditure
Time frame: Baseline, 12 and 24 weeks
Change in daily time in sedentary activity (<3.0 metabolic equivalents =METs)
Time frame: 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
Change in daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs)
Time frame: 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
Change in daily average total physical activity duration
Time frame: Baseline, 12 and 24 weeks
Change in daily average number of steps
Time frame: Baseline, 12 and 24 weeks
Bioelectrical impedance
Time frame: 12 and 24 weeks
systolic Blood Pressure
Time frame: 12 and 24 weeks
Diastolic Blood Pressure
Time frame: 12 and 24 weeks
Fasting circulating glucose, as blood marker of cardiometabolic health
Time frame: 24 weeks
Lipid profile, as blood marker of cardiometabolic health
Time frame: 24 weeks
Circulating insulin concentration, as blood marker of cardiometabolic health
Time frame: 24 weeks
HbA1c from blood samples
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: grunnet COVID-19 pandemien då vi haft hög drop-out og vanskelig att rekruttere). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Derived from this study: PubMed 42103774Berg J, Wang AI, Madssen E, Roe L, Moholdt T. Effects of providing access to a cycling exergaming platform on cardiorespiratory fitness and cardiometabolic health in adolescents: a randomised, controlled trial. Sci Rep. 2026 May 8;16(1):21098. doi: 10.1038/s41598-026-48327-3.
- Individual participant dataSharing planned: No
Related trials for Sedentary Lifestyle
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Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
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Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa, PhD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming in people with Sedentary Lifestyle, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: grunnet COVID-19 pandemien då vi haft hög drop-out og vanskelig att rekruttere). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.