Validation of VO2Max Estimation Methods Using Wearable Biosensors

Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

This study is testing if wearable devices can accurately estimate how well your heart and lungs work during daily activities for both healthy people and those getting standard exercise tests.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Prolaio (industry)
• Locations: 16 sites (Scottsdale, Arizona and 15 other locations)
• Trial ID: NCT05678530 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals aged 18 to 80 and patients undergoing standard CPET as part of their medical care.

Not a fit: Patients who are pregnant, lactating, or have cognitive or physical limitations that prevent them from following study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of cardiopulmonary fitness in patients, enhancing personalized treatment approaches.

How similar studies have performed: While similar studies have explored wearable biosensors, this specific approach to validating VO2Max estimation methods is relatively novel.

Eligibility criteria

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) 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.

Where this trial is running

Scottsdale, Arizona and 15 other locations

• 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)
• Mayo Clinic Florida — Jacksonville, Florida, United States (RECRUITING)
• New Generation of Medical Research — Naples, Florida, United States (RECRUITING)
• physIQ — Chicago, Illinois, United States (COMPLETED)
• University of Illinois Hospital & Health Sciences System — Chicago, Illinois, United States (RECRUITING)
• Advocate Aurora Health Institute — Oakbrook Terrace, Illinois, United States (COMPLETED)
• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
• Baylor Scott & White Research Institute — Dallas, Texas, United States (RECRUITING)
• Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States (RECRUITING)
• Intermountain Medical Center — Murray, Utah, United States (RECRUITING)
• Eastern Health Cardiac Rehabilitation — St. John's, Newfoundland and Labrador, Canada (RECRUITING)

Study contacts

• Study coordinator: Clinical Trials at Prolaio

Conditions: Cardiopulmonary