Validation of Ventriject Determined Maximal Oxygen Uptake

January 13, 2019 updated by: Jørn Wulff Helge, University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

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

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

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 to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy adults

Description

Inclusion Criteria:

- healthy adults between 18 and 45 years of age

Exclusion Criteria:

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

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months data collection, although cross sectional

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
comparison of ECG, echoseismography and echosonography obtained at rest to a measurement of movement (caused by heart contraction) by mobile phone, also at rest
4 months data collection, although cross sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Jørn W Helge, Prof., jhelge@sund.ku

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)

April 23, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 13, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Ventriject1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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

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.

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