Actively Recruiting
Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
Led by Prolaio · Updated on 2025-12-30
1000
Participants Needed
16
Research Sites
407 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Participant is pregnant, lactating or 60 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 (132) 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 16 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
VA Palo Alto Healthcare System
Palo Alto, California, United States, 94304
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
The Lundquist Institute
Torrance, California, United States, 90502
Actively Recruiting
5
Nemours Cardiac Center
Wilmington, Delaware, United States, 19803
Actively Recruiting
6
Memorial Healthcare System, Office of Human Research
Hollywood, Florida, United States, 33021
Actively Recruiting
7
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
New Generation of Medical Research
Naples, Florida, United States, 34116
Actively Recruiting
9
physIQ
Chicago, Illinois, United States, 60606
Completed
10
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States, 60608
Actively Recruiting
11
Advocate Aurora Health Institute
Oakbrook Terrace, Illinois, United States, 60181
Completed
12
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
13
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
14
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
15
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
16
Eastern Health Cardiac Rehabilitation
St. John's, Newfoundland and Labrador, Canada, A1N3J5
Actively Recruiting
Research Team
C
Clinical Trials at Prolaio
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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