Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
- Conditions
- Cardiopulmonary
- Registration Number
- NCT05678530
- Lead Sponsor
- Prolaio
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- Participant is pregnant, lactating or ≤30 days post-partum.
- Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm. 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
VA Palo Alto Healthcare System
🇺🇸Palo Alto, California, United States
The Lundquist Institute
🇺🇸Torrance, California, United States
Memorial Healthcare System, Office of Human Research
🇺🇸Hollywood, 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
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Eastern Health Cardiac Rehabilitation
🇨🇦St. John's, Newfoundland and Labrador, Canada