An observational study in PHYSIOLOGICAL PHENOMENA, Homeostasis and Physical Functional Performance, sponsored by Truway Health, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Truway Health, Inc. · Observational
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.
381 studies on the registry are indexed under Mobility Limitation; 108 are open to participants now.
This study's planned enrollment of 450 is above the median of 75 across 57 observational studies indexed under Mobility Limitation.
Browse Mobility Limitation studies →Truway Health, Inc. is the lead sponsor of 16 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will enroll approximately 450 community-dwelling adults aged 18 through 80 years from outpatient practices, research registries, community outreach, and digital recruitment channels. Approximately 150 participants will be enrolled in each of three cohorts: a Reference Health Cohort, a Stable Cardiometabolic Cohort, and a Stable Respiratory or Mobility Cohort. Recruitment will seek representation across age, sex, race, ethnicity, socioeconomic background, and functional status. Participants must be clinically stable and able to complete protocol assessments. Declining optional biospecimen collection will not preclude participation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meets the criteria for one of the following prespecified cohorts:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 150 generally healthy adults will be observed to establish reference patterns of whole-body physiology, cross-organ coordination, functional capacity, and recovery following a standardized physiologic challenge. Participants will undergo the same research assessments and longitudinal monitoring as the other cohorts. No treatment will be assigned or modified by the study.
Procedure: Standardized Physiologic Resilience Challenge · Other: Multimodal Whole-Body Physiologic Monitoring · Other: Research-Only Whole-Body Digital Twin Analysis
Approximately 150 adults with stable cardiometabolic conditions or risk factors, which may include controlled hypertension, dyslipidemia, obesity, prediabetes, or stable type 2 diabetes, will be observed. The study will characterize physiologic response, cross-system coordination, and recovery in comparison with the reference cohort. No treatment will be assigned or modified by the study.
Procedure: Standardized Physiologic Resilience Challenge · Other: Multimodal Whole-Body Physiologic Monitoring · Other: Research-Only Whole-Body Digital Twin Analysis
Approximately 150 adults with stable chronic respiratory conditions or mobility-related functional limitations will be observed. Eligible participants must be clinically stable and able to complete the study assessments safely, with protocol-permitted accommodations when needed. The study will characterize functional reserve, physiologic response, and recovery in comparison with the other cohorts. No treatment will be assigned or modified by the study.
Procedure: Standardized Physiologic Resilience Challenge · Other: Multimodal Whole-Body Physiologic Monitoring · Other: Research-Only Whole-Body Digital Twin Analysis
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.
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.
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.
Mean Absolute Prediction Error of the Locked Digital Twin for the 30-Minute Whole-Body Resilience Index
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.
Time frame: During the primary assessment visit, from pre-challenge baseline through 30 minutes after completion of the resilience challenge.
Whole-Body Resilience Index at 30 Minutes After the Physiologic Challenge
The observed Whole-Body Resilience Index will be calculated using the prespecified and locked scoring algorithm. The index ranges from 0 to 100 and integrates recovery in heart rate, blood-pressure stabilization, oxygen saturation, respiratory rate, gait performance, and cognitive response performance relative to the participant's pre-challenge baseline. Higher scores indicate greater whole-body physiologic recovery. Scores will be summarized overall and by cohort.
Time frame: Thirty minutes after completion of the resilience challenge during the primary assessment visit.
Time to Multisystem Physiologic Recovery
Time to recovery is the number of minutes from completion of the resilience challenge until heart rate, systolic blood pressure, and respiratory rate are within 10% of the participant's stabilized pre-challenge values and oxygen saturation is within 2 percentage points of its pre-challenge value at two consecutive protocol-specified measurements. Participants who do not meet all recovery criteria within 60 minutes will be classified as not recovered within the observation window.
Time frame: From completion of the resilience challenge through 60 minutes of monitored recovery.
Change in Multisystem Coordination Index From Baseline to 30-Minute Recovery
The Multisystem Coordination Index is a prespecified unitless score ranging from 0 to 1 derived from synchronized temporal relationships among cardiovascular, respiratory, autonomic, oxygenation, and mobility signals. Higher values indicate stronger coordinated physiologic coupling. The outcome is the 30-minute recovery score minus the pre-challenge baseline score. The computational method and signal-processing parameters will be locked before analysis of the independent validation cohort.
Time frame: From the stabilized pre-challenge baseline through 30 minutes after completion of the resilience challenge.
Six-Minute Walk Distance
Total distance walked during the standardized six-minute walk test will be measured in meters using a protocol-defined course and standardized instructions. Greater distance indicates greater functional exercise capacity. Results will be summarized overall and separately for each cohort.
Time frame: Baseline (Day 1), during the primary assessment visit.
Cognitive-Motor Dual-Task Cost
Cognitive-motor dual-task cost will be calculated as the percentage reduction in gait speed during the cognitive dual-task condition relative to the participant's single-task walking speed: \[(single-task gait speed - dual-task gait speed) / single-task gait speed\] × 100. Higher positive percentages indicate greater cognitive-motor interference.
Time frame: Baseline (Day 1), during the primary assessment visit.
Calibration Slope of the Locked Digital-Twin Prediction Model
Model calibration will be evaluated in the independent validation cohort by estimating the slope relating the observed 30-minute Whole-Body Resilience Index to the index predicted by the locked digital-twin model. A calibration slope of 1 indicates agreement between predicted and observed variation. The slope and its 95% confidence interval will be reported.
Time frame: At each scheduled study assessment, from initiation of the assessment through 24 hours after completion.
Participants Experiencing a Study-Procedure-Related Adverse Event
Number and percentage of participants experiencing one or more adverse events assessed by the investigator as related or possibly related to the standardized physiologic challenge, wearable monitoring, biospecimen collection, imaging, or other study procedures. Events will be categorized by severity and relationship to the research procedure.
Time frame: From initiation of each study assessment through 24 hours after completion of that assessment.
Plan to share: Yes — Deidentified individual participant data underlying the published primary and secondary results will be made available. Shared data may include demographic variables, cohort classification, clinical characteristics, derived physiologic measurements, summarized wearable data, functional assessments, Whole-Body Resilience Index components and scores, digital-twin predictions, outcome measures, and adverse-event data. Direct identifiers, free-text clinical records, facial images, raw data presenting an unacceptable reidentification risk, and biospecimen-derived data not covered by participant consent will not be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will become available beginning 12 months after publication of the primary study results or 24 months after study completion, whichever occurs first. Approved datasets and supporting materials will remain available for five years.
Access criteria: Access may be granted to qualified researchers who submit a methodologically sound scientific proposal. Requests will be reviewed for scientific merit, participant-consent compatibility, privacy risk, data-security safeguards, and consistency with applicable law and ethics requirements. Approved requesters must execute a data-use agreement, use the data solely for the approved purpose, protect confidentiality, refrain from attempting reidentification, and acknowledge the original study. Data will be provided through a controlled-access repository or other secure transfer mechanism. Requests may be submitted to [gavin@truwayhealth.com](mailto:gavin@truwayhealth.com).
Data sharing details ↗ · truwayhealth.com
Started Aug 2026 (actual). Primary completion is estimated for Mar 2039, 151 months after the start.
Of 25 observational studies under Mobility Limitation, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 42. This study's planned 151 months is above that.
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