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Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
Sponsor: Prolaio
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2019-06-06
Completion Date
2027-03-31
Last Updated
2025-12-30
Healthy Volunteers
Yes
Conditions
Locations (16)
Mayo Clinic Arizona
Scottsdale, Arizona, United States
VA Palo Alto Healthcare System
Palo Alto, California, United States
University of California San Francisco
San Francisco, California, United States
The Lundquist Institute
Torrance, California, United States
Nemours Cardiac Center
Wilmington, Delaware, United States
Memorial Healthcare System, Office of Human Research
Hollywood, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
New Generation of Medical Research
Naples, Florida, United States
physIQ
Chicago, Illinois, United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States
Advocate Aurora Health Institute
Oakbrook Terrace, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Eastern Health Cardiac Rehabilitation
St. John's, Newfoundland and Labrador, Canada