Estimated VO2Max Validation

Cardiopulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678530
• Other study ID #: CTP-020
• Status: Recruiting
• Start date: June 6, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Prolaio
• Contact: Clinical Trials at Prolaio
• Phone: 855-869-9054
• Email: hello[@]prolaio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary

Locations

Country	Name	City	State
United States	physIQ	Chicago	Illinois
United States	University of Illinois Hospital & Health Sciences System	Chicago	Illinois
United States	Advocate Aurora Health Institute	Oakbrook Terrace	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Prolaio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	December, 2024