Enrolling by invitation
Observational
Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)
Condition(s) studied
PHYSIOLOGICAL PHENOMENAHomeostasisPhysical Functional PerformanceCardiorespiratory FitnessCardiometabolic Risk FactorsMobility Limitation
Investigational drug(s) / intervention(s)
Standardized Physiologic Resilience ChallengeMultimodal Whole-Body Physiologic MonitoringResearch-Only Whole-Body Digital Twin Analysis
Standardized Physiologic Resilience Challenge: Participants will complete a standardized, nontherapeutic sequence that may include baseline rest and stabilization, active standing, a six-minute walk, a cognitive dual task, and monitored recovery. Synchronized physiologic and functional measurements will be collected before, during, and after the challenge to quantify response magnitude, cross-system coordination, and recovery kinetics. This procedure is performed for observational research and does not assign treatment.
Multimodal Whole-Body Physiologic Monitoring: Participants will undergo multimodal longitudinal monitoring using research assessments that may include wearable sensors, electrocardiography, blood pressure, pulse oximetry, respiratory measurements, body composition, sleep and activity monitoring, mobility testing, symptom assessments, and point-of-care imaging. Measurements will be synchronized when feasible to characterize whole-body physiologic state and change over time. Study-generated measurements are observational and will not be used to direct treatment.
Research-Only Whole-Body Digital Twin Analysis: A version-controlled computational model will integrate each participant's longitudinal physiologic, functional, clinical, imaging, wearable, and optional biospecimen-derived data. The model will estimate whole-body resilience, organ-system interactions, physiologic reserve, and recovery trajectories. Model development will use a prespecified training sample, followed by locked validation in an independent sample. Digital-twin outputs are investigational, research-only, and will not be used for diagnosis or clinical decision-making.
Study summary
TRU-OMNIBODY is a prospective observational study designed to develop and independently validate a research-only whole-body digital twin. The digital twin will combine measurements from multiple body systems to create a participant-specific representation of physiologic state, resilience, and recovery.
The study plans to enroll approximately 450 adults between 18 and 80 years of age. Participants will include generally healthy adults and adults with stable cardiometabolic, respiratory, or mobility-related conditions. Study measurements may include wearable-sensor data, heart rate and rhythm, blood pressure, oxygen saturation, autonomic responses, body composition, mobility, muscle function, sleep, activity, cognitive performance, point-of-care imaging, laboratory measurements, and optional biospecimens.
Participants will complete a standardized resilience assessment consisting of rest, active standing, a six-minute walk, a cognitive dual task, and monitored recovery. Selected measurements will also be collected during home monitoring and follow-up visits for up to 12 months.
The primary objective is to determine how accurately a locked digital-twin model predicts Whole-Body Recovery Burden, a research measure derived from the timing and magnitude of recovery across several physiologic systems. Model development and testing will be separated so that the final evaluation is performed in an independent validation cohort.
This study does not assign participants to a medical treatment. Digital-twin outputs will not be used to diagnose disease, recommend treatment, or replace evaluation by a qualified health care professional.
Eligibility
Inclusion Criteria:
* Age 18 through 80 years at enrollment.
* Able and willing to provide written informed consent.
* Able to understand study instructions and comply with protocol assessments.
* Able to complete the standardized physiologic resilience challenge safely, with a customary assistive device or protocol-permitted accommodation when needed.
* Clinically stable at screening, with no significant acute change in health status or prescribed medication regimen during the preceding 30 days, unless determined by the investigator not to affect participant safety or study measurements.
* Willing to undergo multimodal physiologic monitoring and use study-provided or compatible wearable equipment.
* Meets the criteria for one of the following prespecified cohorts:
1. Reference Health Cohort: Generally healthy adult without an unstable or clinically significant condition expected to prevent safe completion of the protocol or materially impair interpretation of the reference measurements.
2. Stable Cardiometabolic Cohort: Adult with one or more stable cardiometabolic conditions or risk factors, which may include controlled hypertension, dyslipidemia, obesity, prediabetes, or stable type 2 diabetes, without recent acute cardiometabolic decompensation.
3. Stable Respiratory or Mobility Cohort: Adult with a stable chronic respiratory condition or mobility-related functional limitation, without a recent exacerbation, acute injury, or acute functional decline that would make protocol assessments unsafe.
* Participants meeting criteria for more than one clinical cohort will be assigned according to the prespecified cohort-classification hierarchy.
* Participation in optional biospecimen collection requires separate consent; declining optional biospecimen collection will not otherwise exclude an eligible participant.
Exclusion Criteria:
* Inability or unwillingness to provide informed consent.
* Acute illness, febrile illness, or suspected communicable infection at the time of assessment.
* Hospitalization, major surgery, or clinically significant acute medical event within 30 days before enrollment, unless reviewed and cleared by the investigator.
* Unstable cardiovascular disease, including recent acute coronary syndrome, decompensated heart failure, uncontrolled clinically significant arrhythmia, or symptomatic severe valvular disease.
* Acute respiratory exacerbation, unstable oxygen requirement, or resting respiratory status that the investigator determines would make the challenge unsafe.
* Resting blood pressure, heart rate, oxygen saturation, or other screening measurement outside the protocol-defined safety limits after repeat assessment.
* Recent syncope, recurrent unexplained falls, acute musculoskeletal injury, or another condition that would prevent safe standing, walking, or recovery monitoring.
* Neurologic, cognitive, psychiatric, visual, hearing, or communication impairment that would prevent informed consent or reliable completion of study procedures despite reasonable accommodation.
* Known intolerance to required wearable sensors, electrodes, adhesives, or monitoring procedures that cannot be addressed using an approved alternative.
* Participation in another clinical study or exposure to an investigational intervention that, in the investigator's judgment, could confound study measurements or increase risk.
* Any medical, functional, or behavioral condition that the investigator or designated medical monitor determines would create an unacceptable risk or compromise the scientific validity of the collected data.
Primary outcome measure(s)
- Mean Absolute Prediction Error of the Locked Digital Twin for the 30-Minute Whole-Body Resilience Index — During the primary assessment visit, from pre-challenge baseline through 30 minutes after completion of the resilience challenge.
In the independent validation cohort, the locked digital-twin model will predict each participant's Whole-Body Resilience Index at 30 minutes after completion of the standardized physiologic resilience challenge. The observed index is a prespecified score ranging from 0 to 100 that integrates normalized recovery across cardiovascular, respiratory, autonomic, mobility, and cognitive domains. The primary outcome is the mean absolute difference, expressed in index points, between the predicted and observed scores. Lower prediction error indicates greater model accuracy.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Truway Health, Inc. |
New York |
New York |
|