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RECRUITING
NCT05678530

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

Sponsor: Prolaio

View on ClinicalTrials.gov

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 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 Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2019-06-06

Completion Date

2027-03-31

Last Updated

2025-12-30

Healthy Volunteers

Yes

Conditions

Locations (16)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

VA Palo Alto Healthcare System

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

The Lundquist Institute

Torrance, California, United States

Nemours Cardiac Center

Wilmington, Delaware, United States

Memorial Healthcare System, Office of Human Research

Hollywood, Florida, United States

Mayo Clinic Florida

Jacksonville, 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

Mayo Clinic

Rochester, Minnesota, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Eastern Health Cardiac Rehabilitation

St. John's, Newfoundland and Labrador, Canada