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

Conditions

• Cardiopulmonary

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Jun 6, 2019

Status verified

Dec 2025

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: Healthy
  Healthy Subjects who undergo the CPET
• Arm: Standard of Care
  Standard of Care subjects who undergo the CPET as part of routine Standard of Care

Primary Outcome Measure

Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm. [ Time Frame: March 2025 ]

Central Contacts

• Clinical Trials at Prolaio
  855-869-9054
  [email protected]

Locations (15)

Find similar trials in Scottsdale, AZ

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