Validation of Ventriject Determined Maximal Oxygen Uptake

Healthy Clinical Trial

Official title:

Validation of Ventriject Determined Maximal Oxygen Uptake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504306
• Other study ID #: Ventriject1
• Status: Completed
• Start date: April 23, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Denmark	Xlab, Faculty of Health and Medical Sciences, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months data collection, although cross sectional
Secondary	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	4 months data collection, although cross sectional