Trials / Recruiting
RecruitingNCT05678530
Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Prolaio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 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.
Conditions
Timeline
- Start date
- 2019-06-06
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
- First posted
- 2023-01-10
- Last updated
- 2025-12-30
Locations
16 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT05678530. Inclusion in this directory is not an endorsement.