Molecular Indicators of Systematic Fitness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: There is no intervention..
- Who it may be relevant to
- Registry conditions: Healthy Adult, Fitness Testing, Athlete, Aging. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this study is to characterize associations between cardiorespiratory fitness, as measured by VO₂max/VO₂peak, and blood-based molecular measurements in adults. This is an observational study where research staff measures VO₂max/VO₂peak and collects fasted, resting blood samples on the same day. The main questions it aims to answer are: 1. Can a multi-analyte blood panel accurately predict directly measured VO₂max/VO₂peak? 2. How do these blood-based features vary across age, sex, and self-reported or documented physical activity profiles? 3. Are the predictor analytes able to capture changes in VO₂max/VO₂peak caused by a self-directed intervention (e.g., training for a marathon)? 4. What is the analytic reliability of the predictor biomarkers?
Detailed description
Prospective observational cohort with baseline cross-sectional assessment; optional longitudinal follow-up with repeat VO₂max and blood collection in a subset. No intervention is assigned by the investigators. The investigators are amassing a large dataset of diverse individuals with directly measured VO2max paired with blood samples to support robust biomarker development.
Interventions
- Other There is no intervention.
The investigators are not administering an intervention for this study. To opportunistically capture prospective data, the investigators give participants the option for re-testing after a period of time where participants are undergoing a self-directed intervention (i.e., no influence of the research staff), such as training for a marathon or other fitness event.
Primary outcome measures
- A multi-analyte biomarker panel to predict maximal aerobic capacity [Time frame: Day 1]
- The change in VO2max/VO2peak and a multi-analyte biomarker panel after a self-directed training program. [Time frame: From day 1 through study completion, average of 3 months]
Eligibility criteria
Inclusion criteria
- Be ≥18 years old
- Be able to understand and provide informed consent (English; additional languages may be added via amendment with translated materials)
- Be willing to complete VO₂max testing, blood draw, and questionnaires.
- Be able to safely perform maximal/symptom-limited exercise testing as determined by: PAR-Q+ screening and investigator review (included as an attachment) and resting vitals screening (heart rate)
Exclusion criteria
- Conditions that, in the investigator's judgment, or a medical doctor, makes maximal exercise testing unsafe (e.g., unstable cardiovascular symptoms)
- Contraindications or unwillingness to undergo venipuncture
- Acute illness (fever, significant respiratory illness) at the time of testing
- Failure to comply with procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- VO Health, Inc. — New Haven
Identifiers
NCT: NCT07393841 · 9554ed94-872a-4b5c-8a42-13e51f