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

Recruiting

• Conditions: Cardiopulmonary

• Registration Number: NCT05678530
• Lead Sponsor: Prolaio

Brief 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 500 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 400 participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-10
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-24
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm.	March 2025	Develop an Estimated VO2Max (eVO2Max) algorithm which will estimate a participant's VO2Max value using data collected from physiological wearable biosensors (ECG \& Activity).

Trial Locations

Locations (15)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

VA Palo Alto Healthcare System; 🇺🇸 Palo Alto, 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

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