Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
1 other identifier
observational
1,000
2 countries
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2019
CompletedFirst Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
December 30, 2025
December 1, 2025
7.8 years
December 5, 2022
December 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm.
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
Study Arms (2)
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
Eligibility Criteria
Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care
You may qualify if:
- Willing and able to comply with protocol procedures and available for the duration of the study.
- Willing to sign and date informed consent document for study participation.
- Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care
You may not qualify if:
- Participant is pregnant, lactating or ≤30 days post-partum.
- 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.
- Barostim (™) or similar noncardiac electrical pulse generating device in situ.
- 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.
- Any history of allergy to adhesive
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prolaiolead
Study Sites (16)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
VA Palo Alto Healthcare System
Palo Alto, California, 94304, United States
University of California San Francisco
San Francisco, California, 94143, United States
The Lundquist Institute
Torrance, California, 90502, United States
Nemours Cardiac Center
Wilmington, Delaware, 19803, United States
Memorial Healthcare System, Office of Human Research
Hollywood, Florida, 33021, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
New Generation of Medical Research
Naples, Florida, 34116, United States
physIQ
Chicago, Illinois, 60606, United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60608, United States
Advocate Aurora Health Institute
Oakbrook Terrace, Illinois, 60181, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Eastern Health Cardiac Rehabilitation
St. John's, Newfoundland and Labrador, A1N3J5, Canada
Study Officials
- STUDY DIRECTOR
Greg Kurio, MD
Prolaio, Inc
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2022
First Posted
January 10, 2023
Study Start
June 6, 2019
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share