Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)

Overview

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.

Human physiologic resilience depends on coordinated responses across the cardiovascular, respiratory, autonomic, metabolic, musculoskeletal, sensory, immune, behavioral, and environmental domains. Conventional clinical measurements generally evaluate these systems separately and at isolated points in time. TRU-OMNIBODY will investigate whether multimodal longitudinal measurements can be integrated into a participant-specific digital twin that represents whole-body physiologic reserve and recovery dynamics. The study is designed as a prospective observational development-and-external-validation cohort. Approximately 450 adults aged 18 through 80 years will be enrolled across three planned cohorts: a reference-health cohort, a stable cardiometabolic cohort, and a stable respiratory or mobility-related cohort. Approximately 300 participants will contribute to model development, internal resampling, and model selection. Approximately 150 participants will be reserved for independent external validation. Validation data will remain separated from model-development activities until the digital-twin model, preprocessing procedures, model parameters, missing-data rules, and evaluation methods have been locked. The whole-body measurement architecture may include continuous or episodic wearable-sensor measurements, electrocardiography, heart rate, blood pressure, pulse oximetry, respiratory measurements, autonomic testing, body composition, mobility and gait measurements, muscle strength, balance, sleep, physical activity, cognitive performance, point-of-care imaging, standard laboratory measurements, and optional biospecimen or multiomic assessments. Device identity, firmware, measurement quality, timing, and data provenance will be recorded when applicable. At baseline, participants will complete a standardized resilience challenge. The planned sequence includes a resting stabilization period, transition from a monitored resting position to standing, a functional walking assessment, a validated cognitive dual task, and monitored recovery. Measurements collected before, during, and after the challenge will be used to characterize the magnitude, timing, coordination, and completeness of recovery across physiologic domains. A subset of participants may repeat the assessment within approximately 7 to 14 days to evaluate test-retest reliability. Participants may also complete scheduled home monitoring, symptom and activity reporting, quarterly assessments, and final follow-up for up to 12 months. Longitudinal data will be used to establish participant-specific baselines, quantify within-person variation, and examine whether persistent deviations from personal baseline are associated with subsequently adjudicated health events or clinically meaningful changes. Health events will be evaluated according to prespecified adjudication procedures rather than inferred solely from digital-twin output. The primary analysis will evaluate prediction error for Whole-Body Recovery Burden in the independent validation cohort. Whole-Body Recovery Burden is a prespecified research outcome representing integrated recovery delay or incomplete recovery across measured physiologic domains. The primary performance measure will compare the locked model prediction with the observed outcome following the standardized challenge. Secondary analyses will evaluate reliability, calibration, discrimination, uncertainty, missingness, domain-specific recovery, participant burden, protocol feasibility, and performance across demographic and clinical subgroups. Exploratory analyses will evaluate cross-organ coupling, multimodal recovery phenotypes, individual resilience trajectories, change-point patterns, and the relationship between deviations from personal baseline and adjudicated health-state changes. Participant-level uncertainty estimates or abstention rules will be used when input quality is inadequate or measurements fall outside the model's supported range. TRU-OMNIBODY is observational and does not assign a drug, biologic, device treatment, or therapeutic strategy. Investigational digital-twin outputs will remain separated from routine clinical decision-making and will not independently diagnose disease, recommend treatment, or direct participant care. Clinically significant observations obtained through validated conventional measurements will be managed according to the approved protocol, safety procedures, informed-consent document, and site-specific clinical escalation plan.