Clinical trial NCT05678530: Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
Official title: Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiopulmonary
Lead sponsor: Prolaio
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care

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 300 participants will be enrolled including: (Normal) 200 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 100 participants


Eligibility criteria: 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. Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures

Primary outcomes:
measure: Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm.
timeFrame: March 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Healthcare System
state: California
city: Torrance
country: United States
facility: The Lundquist Institute
state: California
city: Hollywood
country: United States
facility: Memorial Healthcare System, Office of Human Research
state: Florida
city: Naples
country: United States
facility: New Generation of Medical Research
state: Florida
city: Chicago
country: United States
facility: physIQ
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Advocate Aurora Health Institute
state: Illinois
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: St. John's
country: Canada
facility: Eastern Health Cardiac Rehabilitation
state: Newfoundland and Labrador
Study officials:
affiliation: Prolaio, Inc
name: Greg Kurio, MD
role: STUDY_DIRECTOR
References: