Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

December 22, 2025 updated by: Prolaio
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 1000 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 900 participants.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

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

  • Name: Clinical Trials at Prolaio
  • Phone Number: 855-869-9054
  • Email: hello@prolaio.com

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1N3J5
        • Recruiting
        • Eastern Health Cardiac Rehabilitation
        • Contact:
        • Principal Investigator:
          • Liam Kelly, PhD
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
        • Principal Investigator:
          • Courtney Wheatley-Guy, PhD
        • Contact:
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • VA Palo Alto Healthcare System
        • Contact:
        • Principal Investigator:
          • Jonathan Myers, PhD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Theodore Abraham, MD
      • Torrance, California, United States, 90502
        • Recruiting
        • The Lundquist Institute
        • Principal Investigator:
          • William Stringer, MD
        • Contact:
        • Contact:
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours Cardiac Center
        • Contact:
        • Principal Investigator:
          • Takeshi Tsuda, MD
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Healthcare System, Office of Human Research
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 954-265-1849
          • Email: PamShaw@mhs.net
        • Principal Investigator:
          • Iani Patsias, MD
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Principal Investigator:
          • Bryan J. Taylor, PhD
        • Contact:
      • Naples, Florida, United States, 34116
        • Recruiting
        • New Generation of Medical Research
        • Contact:
        • Principal Investigator:
          • Daniel Morales, MD
    • 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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Thomas P. Olson, PhD
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Research Institute
        • Principal Investigator:
          • Mark Millard, MD
        • Contact:
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White The Heart Hospital - Plano
        • Contact:
        • Principal Investigator:
          • Aasim M. Afzal, MD
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
          • Project Coordinator, Outpatient Pulmonary Research
          • Phone Number: 801-507-4800
          • Email: Stan.Pies@imail.org
        • Principal Investigator:
          • Matthew J. Hegewald, MD

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

Yes

Sampling Method

Probability Sample

Study Population

Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care

Description

Inclusion Criteria:

  1. Willing and able to comply with protocol procedures and available for the duration of the study.
  2. Willing to sign and date informed consent document for study participation.
  3. Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care

Exclusion Criteria:

  1. Participant is pregnant, lactating or ≤30 days post-partum.

  2. Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing).

    • If participant has an indwelling cardiac device and programming cannot be sufficiently ascertained to assure sinus node competence and lack of atrial pacing, the patient should be excluded.

  3. Barostim (™) or similar noncardiac electrical pulse generating device in situ.

  4. Complex congenital heart disease (even repaired or palliated) with the following exception:

    • Biventricular physiology without severe valvar dysfunction (e.g. free pulmonary insufficiency) at the discretion of the investigator.

  5. Any history of allergy to adhesive
  6. Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach a respiratory exchange ratio of 1.0.

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
Healthy
Healthy Subjects who undergo the CPET
Standard of Care
Standard of Care subjects who undergo the CPET as part of routine Standard of Care

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: March 2025
Develop an Estimated VO2Max (eVO2Max) algorithm which will estimate a participant's VO2Max value using data collected from physiological wearable biosensors (ECG & Activity).
March 2025

Collaborators and Investigators

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

Sponsor

Prolaio

Investigators

  • Study Director: Greg Kurio, MD, Prolaio, 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 (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

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

product manufactured in and exported from the U.S.

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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