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NCT Number: NCT05678530

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Health Cardiac Rehabilitation, St. John's, Newfoundland and Labrador, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials at Prolaio

CONTACT

[email protected]

855-869-9054

Sponsors and collaborators

Lead sponsor

Prolaio

Industry

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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