Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET) (NCT05678530)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Scottsdale, Arizona
Age range: 18 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Mayo Clinic Arizona — Scottsdale, Arizona
- VA Palo Alto Healthcare System — Palo Alto, California
- University of California San Francisco — San Francisco, California
- The Lundquist Institute — Torrance, California
- Nemours Cardiac Center — Wilmington, Delaware
- Memorial Healthcare System, Office of Human Research — Hollywood, Florida
- Mayo Clinic Florida — Jacksonville, Florida
- New Generation of Medical Research — Naples, Florida
- physIQ — Chicago, Illinois
- University of Illinois Hospital & Health Sciences System — Chicago, Illinois
- Advocate Aurora Health Institute — Oakbrook Terrace, Illinois
- Mayo Clinic — Rochester, Minnesota
- Baylor Scott & White Research Institute — Dallas, Texas
- Baylor Scott & White The Heart Hospital - Plano — Plano, Texas
- Intermountain Medical Center — Murray, Utah
- Eastern Health Cardiac Rehabilitation — St. John's, Newfoundland and Labrador
📞 Contact the Study Coordinator
Phone: (855) 869-9054
Email: hello@prolaio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Cardiopulmonary clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.