Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiopulmonary. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm. [Time frame: March 2025]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 15 centers
- Mayo Clinic Arizona — Scottsdale
- VA Palo Alto Healthcare System — Palo Alto
- University of California San Francisco — San Francisco
- The Lundquist Institute — Torrance
- Nemours Cardiac Center — Wilmington
- Memorial Healthcare System, Office of Human Research — Hollywood
- Mayo Clinic Florida — Jacksonville
- New Generation of Medical Research — Naples
- … and 7 more centers
Canada · 1 center
- Eastern Health Cardiac Rehabilitation — St. John's
Identifiers
NCT: NCT05678530 · CTP-020