Validation of VO2Max Estimation Methods Using Wearable Biosensors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate methods for estimating VO2Max and other cardiopulmonary exercise test (CPET) parameters using data collected from wearable biosensors during daily activities. Participants will include both healthy individuals and those undergoing standard CPET as part of their care. The study will gather data to develop and validate a machine learning algorithm designed to improve the accuracy of these estimations. A total of 300 participants will be enrolled to support this validation process.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to comply with protocol procedures and available for the duration of the study.
2. Willing to sign and date informed consent document for study participation.
3. Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care

Exclusion Criteria:

1. Participant is pregnant, lactating or ≤30 days post-partum.
2. 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.
3. Barostim (™) or similar noncardiac electrical pulse generating device in situ.
4. 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.
5. Any history of allergy to adhesive
6. 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, or perform a maximal CPET in the judgement of the investigator, and/or any limitations pertaining to obtaining a complete Echo

Where it's running

• Mayo Clinic Arizona
  Scottsdale, Arizona, United States Recruiting
• VA Palo Alto Healthcare System
  Palo Alto, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• The Lundquist Institute
  Torrance, California, United States Recruiting
• Nemours Cardiac Center
  Wilmington, Delaware, United States Recruiting
• Memorial Healthcare System, Office of Human Research
  Hollywood, Florida, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials at Prolaio
• Email: hello@prolaio.com
• Phone: 855-869-9054

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.