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

NCT05678530 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • Cardiopulmonary

Sponsors & Collaborators

  • Prolaio

    lead INDUSTRY

Principal Investigators

  • Greg Kurio, MD · Prolaio, Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05678530 on ClinicalTrials.gov