Sedentary LifestyleNCT04112329
Exergaming for Better Physical Fitness
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 project is to assess if playing a newly developed videogame that require physical activity (e.g. exergame) can lead to increased physical activity, aerobic fitness and health benefits in sedentary adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 14 Oct 2019to 1 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary (<150 mins of moderate intensity physical activity/week) and/or do not regularly take part in endurance training.
- Able to ride a bike for up to 60 minutes
Who cannot join
- Known cardiovascular disease
- Taking beta-blockers or anti-arrhythmic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 8 Weeks of High-intensity Exergaming on Cardiorespiratory Fitness and Physical Activity Levels in Sedentary Adults
The purpose of this project is to assess if playing a newly developed videogame that require physical activity (e.g. exergame) can lead to increased physical activity, aerobic fitness and health benefits in sedentary adults. The project will include 28 sedentary adults, 18 years and above, who are not sufficiently active according to current guidelines defined as doing (<150 minutes/week of moderate intensity physical activity or <75 minutes/week of vigorous physical activity and/or do not do any regular endurance training ). The physical fitness (maximal oxygen consumption), blood pressure, body composition and objectively measured physical activity will be tested before and after the intervention period.
Also, the participants gaming frequency will be registered throughout the 8 week period. Aim of this study is to investigate if access to this game can provide health benefits for adults who are not motivated to take part in regular physical activity.
- Conditions
- Sedentary Lifestyle
- Being tested
- Exergaming
- Keywords
- Exercise therapy, Physical fitness, Gaming, Child, Healthy lifestyle, Fitness testing
- 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
will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exergaming | Experimental | Will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks 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: 8 weeks
Secondary outcomes (9)
Daily average energy expenditure
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (8 weeks).
Measured: 8 weeks
Daily average number of steps
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (8 weeks).
Measured: 8 weeks
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 and after intervention period (8 weeks).
Measured: 8 weeks
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 and after intervention period (8 weeks).
Measured: 8 weeks
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 and after intervention period (8 weeks).
Measured: 8 weeks
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 and after intervention period (8 weeks).
Measured: 8 weeks
Daily average total physical activity duration
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (8 weeks).
Measured: 8 weeks
Bioelectrical impedance
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (weeks).
Measured: 8 weeks
Blood Pressure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start14 Oct 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
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.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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, Study director, Norwegian University of Science and TechnologyTrine Moholdt, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112329
- Sponsor's protocol ID
- 2019/1083
- Status last verified
- May 2021
- First submitted
- 30 Sep 2019
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berg J, Haugen G, Wang AI, Moholdt T. High-intensity exergaming for improved cardiorespiratory fitness: A randomised, controlled trial. Eur J Sport Sci. 2022 Jun;22(6):867-876. doi: 10.1080/17461391.2021.1921852. Epub 2021 May 16.
PubMed 33944698
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 8 Weeks of High-intensity Exergaming on Cardiorespiratory Fitness and Physical Activity Levels in Sedentary Adults
- ClinicalTrials.gov ID
- NCT04112329
- Acronym / sponsor ID
- 2019/1083
- Conditions
- Sedentary Lifestyle
- Keywords
- Exercise therapy, Physical fitness, Gaming, Child, Healthy lifestyle, Fitness testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 2 Oct 2019 (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 project is to assess if playing a newly developed videogame that require physical activity (e.g. exergame) can lead to increased physical activity, aerobic fitness and health benefits in sedentary adults. The project will include 28 sedentary adults, 18 years and above, who are not sufficiently active according to current guidelines defined as doing (<150 minutes/week of moderate intensity physical activity or <75 minutes/week of vigorous physical activity and/or do not do any regular endurance training ). The physical fitness (maximal oxygen consumption), blood pressure, body composition and objectively measured physical activity will be tested before and after the intervention period.
Also, the participants gaming frequency will be registered throughout the 8 week period. Aim of this study is to investigate if access to this game can provide health benefits for adults who are not motivated to take part in regular physical activity.
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: ExergamingWill use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks |
| Control | No intervention | –Asked to continue with their normal daily routine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sedentary (<150 mins of moderate intensity physical activity/week) and/or do not regularly take part in endurance training.
- Able to ride a bike for up to 60 minutes
Key exclusion criteria (2 listed)
- Known cardiovascular disease
- Taking beta-blockers or anti-arrhythmic drugs
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 |
|---|---|---|
| Exergamingwill use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks. | Behavioural | Exergaming |
Primary outcome
VO2max (Maximal Aerobic Capacity)
Time frame: 8 weeks
9 secondary outcomes
Daily average energy expenditure
Time frame: 8 weeks
Daily average number of steps
Time frame: 8 weeks
Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
Time frame: 8 weeks
Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Time frame: 8 weeks
Daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs)
Time frame: 8 weeks
Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Time frame: 8 weeks
Daily average total physical activity duration
Time frame: 8 weeks
Bioelectrical impedance
Time frame: 8 weeks
Blood Pressure
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Results publication: PubMed 33944698Berg J, Haugen G, Wang AI, Moholdt T. High-intensity exergaming for improved cardiorespiratory fitness: A randomised, controlled trial. Eur J Sport Sci. 2022 Jun;22(6):867-876. doi: 10.1080/17461391.2021.1921852. Epub 2021 May 16.
- Individual participant dataSharing planned: Undecided
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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 study director
Norwegian University of Science and Technology
Trine Moholdt, PhD principal investigator
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 2 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: finished, as of the sponsor's last update on 13 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (Maximal Aerobic Capacity) (time frame: 8 weeks). 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 NCT04112329, 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 13 May 2021.