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

Recruiting now

Conditions studied: Cardiopulmonary

In brief

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 facts

Study ID

NCT05678530

Run by

Prolaio

People needed

1000

Starts

2019-06-06

Expected to finish

2027-03-31

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Participant is pregnant, lactating or ≤30 days post-partum.
• 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.
• Barostim (™) or similar noncardiac electrical pulse generating device in situ.
• 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.
• Any history of allergy to adhesive
• 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 it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
• VA Palo Alto Healthcare System — Palo Alto, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• The Lundquist Institute — Torrance, California, United States (enrolling)
• Nemours Cardiac Center — Wilmington, Delaware, United States (enrolling)
• Memorial Healthcare System, Office of Human Research — Hollywood, Florida, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• New Generation of Medical Research — Naples, Florida, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• Eastern Health Cardiac Rehabilitation — St. John's, Newfoundland and Labrador, Canada (enrolling)
• University of Illinois Hospital & Health Sciences System — Chicago, Illinois, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Baylor Scott & White Research Institute — Dallas, Texas, United States (enrolling)
• Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States (enrolling)
• physIQ — Chicago, Illinois, United States
• Advocate Aurora Health Institute — Oakbrook Terrace, Illinois, United States

Full record on ClinicalTrials.gov

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