HealthyNCT03504306
Validation of Ventriject Determined Maximal Oxygen Uptake
An observational study of Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
This study aims to validate the use of the Ventriject product to estimate VO2 max, through a non-physically active test using ECG, echoseismography and echosonography. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ventriject validation
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Apr 2018to 31 Dec 2018
- Phase
- Observational
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy adults
Who may be able to join
- healthy adults between 18 and 45 years of age
Who cannot join
- current or previous cardiovascular disease
- chronic use of medicine
- pregnancy
- illnesses which prohibits the testing of maximal oxygen uptake
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Copenhagen, 2200
About this study
This study aims to validate the use of the Ventriject product to estimate VO2 max, through a non-physically active test using ECG, echoseismography and echosonography.
Read the detailed description
this study will be composed of the following tests:
- blood sample for measurement of blood values
- blood pressure measurement to rule out risks affiliated with maximal effort testing
- DXA body composition scanning
- Measurement on ECG, echosonography and echoseismography with accelerometer, microphone and ECG wires
- Measurements with phone (iPhone)
- VO2 max assessment by maximal oxygen uptake testing on a training bike, using online oxygenmeasurement equipment
- Hand-grip strength assessment
- Conditions
- Healthy
- Being tested
- Ventriject validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriject validationOther
comparing measurements from echocardiography, echoseismography to measurements of maximal oxygen uptake
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing how well the Ventriject software can estimate VO2 max
VO2 max tested on bike with online software Ventriject will estimate VO2max based on ECG, echoseismography and echosonography obtained at rest
Measured: 4 months data collection, although cross sectional
Secondary outcomes (1)
comparing how well the measurements from the mobile phone test compare to the same measurements with accelerometer and echosonography
comparison of ECG, echoseismography and echosonography obtained at rest to a measurement of movement (caused by heart contraction) by mobile phone, also at rest
Measured: 4 months data collection, although cross sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start23 Apr 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jørn Wulff Helge, University of Copenhagen
- Investigators
- Jørn W Helge, Prof., Principal investigator, jhelge@sund.ku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504306
- Sponsor's protocol ID
- Ventriject1
- Status last verified
- Jan 2019
- First submitted
- 15 Mar 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of IPD is possible if the following terms are met: 1. Identification of the study participant is in no way achieveable from the requested data 2. The participant declares interest in their data being shared through IPD
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Ventriject Determined Maximal Oxygen Uptake
- ClinicalTrials.gov ID
- NCT03504306
- Acronym / sponsor ID
- Ventriject1
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Apr 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.
This study aims to validate the use of the Ventriject product to estimate VO2 max, through a non-physically active test using ECG, echoseismography and echosonography.
Detailed description
this study will be composed of the following tests:
- blood sample for measurement of blood values
- blood pressure measurement to rule out risks affiliated with maximal effort testing
- DXA body composition scanning
- Measurement on ECG, echosonography and echoseismography with accelerometer, microphone and ECG wires
- Measurements with phone (iPhone)
- VO2 max assessment by maximal oxygen uptake testing on a training bike, using online oxygenmeasurement equipment
- Hand-grip strength assessment
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy adults
Key inclusion criteria (1 listed)
- healthy adults between 18 and 45 years of age
Key exclusion criteria (4 listed)
- current or previous cardiovascular disease
- chronic use of medicine
- pregnancy
- illnesses which prohibits the testing of maximal oxygen uptake
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 |
|---|---|---|
| Ventriject validationcomparing measurements from echocardiography, echoseismography to measurements of maximal oxygen uptake | Other | – |
Primary outcome
Comparing how well the Ventriject software can estimate VO2 max
Time frame: 4 months data collection, although cross sectional
VO2 max tested on bike with online software Ventriject will estimate VO2max based on ECG, echoseismography and echosonography obtained at rest
1 secondary outcome
comparing how well the measurements from the mobile phone test compare to the same measurements with accelerometer and echosonography
Time frame: 4 months data collection, although cross sectional
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 15 Jan 2019.
- Individual participant dataSharing planned: Undecided. Sharing of IPD is possible if the following terms are met: 1. Identification of the study participant is in no way achieveable from the requested data 2. The participant declares interest in their data being shared through IPD
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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.
Jørn W Helge, Prof. principal investigator
jhelge@sund.ku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Copenhagen at 1 site in Denmark.
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 1 inclusion and 4 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 15 Jan 2019. 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 Denmark. 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?
Comparing how well the Ventriject software can estimate VO2 max (time frame: 4 months data collection, although cross sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2019.