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Validation of Ventriject Determined Maximal Oxygen Uptake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03504306
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jørn Wulff Helge, University of Copenhagen

Brief 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.

Condition or disease Intervention/treatment
Healthy Other: Ventriject validation

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

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of Ventriject Determined Maximal Oxygen Uptake
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy


Intervention Details:
  • Other: Ventriject validation
    comparing measurements from echocardiography, echoseismography to measurements of maximal oxygen uptake


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
blood samples for testing blood values


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   50/50 gender composition, meaning uptake of participants of a gender will end when the group reaches 50 participants
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy adults
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504306


Locations
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Denmark
Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Jørn W Helge, Prof. jhelge@sund.ku

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Responsible Party: Jørn Wulff Helge, Prof. Jørn Wulff Helge, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03504306     History of Changes
Other Study ID Numbers: Ventriject1
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No