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 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
Condition
- Cardiopulmonary
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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. Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures
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
VA Palo Alto Healthcare System
Palo Alto, California 94304
Palo Alto, California 94304
The Lundquist Institute
Torrance, California 90502
Torrance, California 90502
Memorial Healthcare System, Office of Human Research
Hollywood, Florida 33021
Hollywood, Florida 33021
New Generation of Medical Research
Naples, Florida 34116
Naples, Florida 34116
University of Illinois Hospital & Health Sciences System
Chicago, Illinois 60608
Chicago, Illinois 60608
Baylor Scott & White Research Institute
Dallas, Texas 75246
Dallas, Texas 75246
Contact:
Clinical Research Coordinator - Pulmonary Research
214-820-2766
LuisFelipe.GarridoTrevino@bswhealth.org
Clinical Research Coordinator - Pulmonary Research
214-820-2766
LuisFelipe.GarridoTrevino@bswhealth.org
More Details
- NCT ID
- NCT05678530
- Status
- Recruiting
- Sponsor
- Prolaio