Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
Purpose
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.
Condition
- Cardiopulmonary
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- Participant is pregnant, lactating or ≤30 days post-partum. 2. Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing). • If participant has an indwelling cardiac device and programming cannot be sufficiently ascertained to assure sinus node competence and lack of atrial pacing, the patient should be excluded. 3. Barostim (™) or similar noncardiac electrical pulse generating device in situ. 4. Complex congenital heart disease (even repaired or palliated) with the following exception: • Biventricular physiology without severe valvar dysfunction (e.g. free pulmonary insufficiency) at the discretion of the investigator. 5. Any history of allergy to adhesive 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Healthy | Healthy Subjects who undergo the CPET | |
| Standard of Care | Standard of Care subjects who undergo the CPET as part of routine Standard of Care |
Recruiting Locations
Mayo Clinic Arizona
Scottsdale 5313457, Arizona 5551752 85259
Scottsdale 5313457, Arizona 5551752 85259
VA Palo Alto Healthcare System
Palo Alto 5380748, California 5332921 94304
Palo Alto 5380748, California 5332921 94304
University of California San Francisco
San Francisco 5391959, California 5332921 94143
San Francisco 5391959, California 5332921 94143
The Lundquist Institute
Torrance 5403022, California 5332921 90502
Torrance 5403022, California 5332921 90502
Nemours Cardiac Center
Wilmington 4145381, Delaware 4142224 19803
Wilmington 4145381, Delaware 4142224 19803
Memorial Healthcare System, Office of Human Research
Hollywood 4158928, Florida 4155751 33021
Hollywood 4158928, Florida 4155751 33021
Mayo Clinic Florida
Jacksonville 4160021, Florida 4155751 32224
Jacksonville 4160021, Florida 4155751 32224
New Generation of Medical Research
Naples 4165565, Florida 4155751 34116
Naples 4165565, Florida 4155751 34116
University of Illinois Hospital & Health Sciences System
Chicago 4887398, Illinois 4896861 60608
Chicago 4887398, Illinois 4896861 60608
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Baylor Scott & White Research Institute
Dallas 4684888, Texas 4736286 75246
Dallas 4684888, Texas 4736286 75246
Baylor Scott & White The Heart Hospital - Plano
Plano 4719457, Texas 4736286 75093
Plano 4719457, Texas 4736286 75093
Intermountain Medical Center
Murray 5778755, Utah 5549030 84107
Murray 5778755, Utah 5549030 84107
More Details
- NCT ID
- NCT05678530
- Status
- Recruiting
- Sponsor
- Prolaio