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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProlaio

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Participant is pregnant, lactating or ≤30 days post-partum.

Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing).

Barostim (™) or similar noncardiac electrical pulse generating device in situ.

Any history of allergy to adhesive

Trial population

Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: Healthy
Group B: Standard of Care

Trial outcomes

Primary outcomes

1

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

Develop an Estimated VO2Max (eVO2Max) algorithm which will estimate a participant's VO2Max value using data collected from physiological wearable biosensors (ECG \& Activity).

Time frame
March 2025

Secondary outcomes

Other outcomes

Sponsors and contacts

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