Estimated VO2Max Validation

January 4, 2023 updated by: physIQ, Inc.

Validation of VO2Max Estimations Using Healthy and Standard of Care Participants

In this study, the hypothesis being explored is that VO2Max and other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected during activities of daily living using wearable biosensors worn by study participants. This study will aim to collect development and validation data for a machine learning algorithm and to evaluate the performance of the algorithm. A total of 300 participants will be enrolled including: (Normal) 200 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 100 participants

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60606
        • Completed
        • physIQ
      • Chicago, Illinois, United States, 60608
        • Recruiting
        • University of Illinois Hospital & Health Sciences System
        • Contact:
        • Principal Investigator:
          • Cemal Ozemek, PhD
      • Oakbrook Terrace, Illinois, United States, 60181
        • Completed
        • Advocate Aurora Health Institute

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy Group: One cohort of participants will be "normal" (healthy) participants who volunteer for CPET testing.

Standard of Care Group: The second cohort of patients will be those with any medical diagnosis that necessitates investigation of functional capacity through cardiopulmonary exercise testing (testing as part of standard of care).

Description

Inclusion Criteria:

  • Has a clinical indication for investigation of functional capacity through cardiopulmonary exercise testing
  • Willing and able to comply with protocol procedures
  • Willing to sign and date informed consent document for study participation

Exclusion Criteria:

  • Participant has cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach and respiratory exchange ratio of 1.0
  • Participant has an allergy to the adhesive used on the VitalPatch
  • Participant is pregnant, lactating or 30 days post-partum

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Standard of Care
Healthy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm.
Time Frame: August, 2023
Develop an Estimated VO2Max (eVO2Max) algorithm which will estimate a participant's VO2Max value using data collected from physiological wearable biosensors (ECG & Activity). This estimation algorithm will be developed using a portion of the collected data (physiological biosignals + CPET) from healthy participants and a portion of data from a separate cohort with a clinical indication requiring functional capacity evaluation (called the Standard of Care Cohort).
August, 2023

Collaborators and Investigators

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

Sponsor

physIQ, Inc.

Investigators

  • Principal Investigator: Steve Steinhubl, MD, physIQ, Inc.

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)

June 6, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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