NCT03504306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

March 15, 2018

Last Update Submit

January 13, 2019

Conditions

Healthy

Outcome Measures

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

    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

    4 months data collection, although cross sectional

Interventions

Ventriject validationOTHER

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

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details50/50 gender composition, meaning uptake of participants of a gender will end when the group reaches 50 participants
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy adults

You may qualify if:

  • \- healthy adults between 18 and 45 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xlab, Faculty of Health and Medical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for testing blood values

Study Officials

  • Jørn W Helge, Prof.

    jhelge@sund.ku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Jørn Wulff Helge

Study Record Dates

First Submitted

March 15, 2018

First Posted

April 20, 2018

Study Start

April 23, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

DK(1)