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CompletedNCT03504306Updated Jan 15, 2019

Validation of Ventriject Determined Maximal Oxygen Uptake

An observational study in Healthy, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by University of Copenhagen · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

healthy adults

Inclusion criteria

  • healthy adults between 18 and 45 years of age

Exclusion criteria

Exclusion Criteria:

  • current or previous cardiovascular disease
  • chronic use of medicine
  • pregnancy
  • illnesses which prohibits the testing of maximal oxygen uptake
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherVentriject validation

    comparing measurements from echocardiography, echoseismography to measurements of maximal oxygen uptake

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 4 months data collection, although cross sectional

07

Study locations

1 site
  • Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
    Copenhagen, 2200, Denmark
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03504306
Lead sponsor
University of Copenhagen
Responsible party
Jørn Wulff Helge (Prof. Jørn Wulff Helge, University of Copenhagen) — Principal investigator
First posted
Apr 20, 2018
Start date
Apr 23, 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Jan 15, 2019

Study contacts

Jørn W Helge, Prof.
principal investigator · jhelge@sund.ku

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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