RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 500 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 400 participants.

Official Title

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

Quick Facts

Study Start:2019-06-06
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05678530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Willing and able to comply with protocol procedures and available for the duration of the study.
  2. 2. Willing to sign and date informed consent document for study participation.
  3. 3. Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care
  1. 1. Participant is pregnant, lactating or ≤30 days post-partum.
  2. 2. Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing).
  3. 3. Barostim (™) or similar noncardiac electrical pulse generating device in situ.
  4. 4. Complex congenital heart disease (even repaired or palliated) with the following exception:
  5. 5. Any history of allergy to adhesive
  6. 6. 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.

Contacts and Locations

Study Contact

Clinical Trials at Prolaio
CONTACT
855-869-9054
hello@prolaio.com

Principal Investigator

Greg Kurio, MD
STUDY_DIRECTOR
Prolaio, Inc

Study Locations (Sites)

Mayo Clinic Arizona
Scottsdale, Arizona, 85259
United States
VA Palo Alto Healthcare System
Palo Alto, California, 94304
United States
University of California San Francisco
San Francisco, California, 94143
United States
The Lundquist Institute
Torrance, California, 90502
United States
Nemours Cardiac Center
Wilmington, Delaware, 19803
United States
Memorial Healthcare System, Office of Human Research
Hollywood, Florida, 33021
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
New Generation of Medical Research
Naples, Florida, 34116
United States
physIQ
Chicago, Illinois, 60606
United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60608
United States
Advocate Aurora Health Institute
Oakbrook Terrace, Illinois, 60181
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246
United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
United States

Collaborators and Investigators

Sponsor: Prolaio

  • Greg Kurio, MD, STUDY_DIRECTOR, Prolaio, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-06
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2019-06-06
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiopulmonary