PHYSIOLOGICAL PHENOMENATRU-OMNIBODYNCT07805044
Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)
An observational study of PHYSIOLOGICAL PHENOMENA and Homeostasis, run by Truway Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- PHYSIOLOGICAL PHENOMENA, Homeostasis, Physical Functional Performance
- What is being tested?
- Standardized Physiologic Resilience Challenge, Multimodal Whole-Body Physiologic Monitoring and Research-Only Whole-Body Digital Twin Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 30 Jun 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- Meets the criteria for one of the following prespecified cohorts:
- 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.
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Development and External Validation of a Multimodal Whole-Body Digital Twin for Quantification of Cross-Organ Physiologic Reserve, Recovery Dynamics, and Emerging Health-State Change
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.
Read more
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.
Read the detailed description
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.
- Conditions
- PHYSIOLOGICAL PHENOMENA, Homeostasis, Physical Functional Performance, Cardiorespiratory Fitness, Cardiometabolic Risk Factors, Mobility Limitation
- Being tested
- Standardized Physiologic Resilience Challenge, Multimodal Whole-Body Physiologic Monitoring, Research-Only Whole-Body Digital Twin Analysis
- Keywords
- Whole-Body Digital Twin, Physiologic Resilience, Whole-Body Recovery Burden, Patient-Specific Modeling, Computer Simulation, Artificial Intelligence, Machine Learning, Predictive Learning Models, Digital Health, Wearable Electronic Devices, Monitoring, Physiologic, Monitoring, Ambulatory, Multimodal Phenotyping, Cross-Organ Physiology, Recovery Dynamics, Allostasis, Physiologic Adaptation
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Physiologic Resilience ChallengeProcedure or surgery
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 MonitoringOther
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 AnalysisOther
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 group | Role | What they receive |
|---|---|---|
| Reference Health Cohort | 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. Receives: Procedure: Standardized Physiologic Resilience Challenge; Other: Multimodal Whole-Body Physiologic Monitoring; Other: Research-Only Whole-Body Digital Twin Analysis | |
| Stable Cardiometabolic Cohort | 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. Receives: Procedure: Standardized Physiologic Resilience Challenge; Other: Multimodal Whole-Body Physiologic Monitoring; Other: Research-Only Whole-Body Digital Twin Analysis | |
| Stable Respiratory or Mobility Cohort | 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. Receives: Procedure: Standardized Physiologic Resilience Challenge; Other: Multimodal Whole-Body Physiologic Monitoring; Other: Research-Only Whole-Body Digital Twin Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the primary assessment visit, from pre-challenge baseline through 30 minutes after completion of the resilience challenge.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At each scheduled study assessment, from initiation of the assessment through 24 hours after completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start31 Aug 2026
- Primary completion31 Mar 2039 (estimated)
- Study completion30 Jun 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PHYSIOLOGICAL PHENOMENAStudies of the same condition, open and under way.
- More trials run by Truway Health, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Truway Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gavin C Solomon, MD, Principal investigator, Truway Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805044
- Sponsor's protocol ID
- TH-OMNIBODY-DT-2026-001
- Acronym
- TRU-OMNIBODY
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Bent B, Wang K, Grzesiak E, Jiang C, Qi Y, Jiang Y, Cho P, Zingler K, Ogbeide FI, Zhao A, Runge R, Sim I, Dunn J. The digital biomarker discovery pipeline: An open-source software platform for the development of digital biomarkers using mHealth and wearables data. J Clin Transl Sci. 2020 Jul 14;5(1):e19. doi: 10.1017/cts.2020.511.
PubMed 33948242Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Bandeen-Roche K, Zhu J, Xue QL, Buta B, Laskow T, Walston JD, Varadhan R. Characterization of Dynamic Adaptation to Stressors Using Multisystem Stimulus-Response Data: The Study of Physical Resilience in Aging Pilot. J Gerontol A Biol Sci Med Sci. 2025 May 5;80(6):glaf056. doi: 10.1093/gerona/glaf056.
PubMed 40088116Varadhan R, Seplaki CL, Xue QL, Bandeen-Roche K, Fried LP. Stimulus-response paradigm for characterizing the loss of resilience in homeostatic regulation associated with frailty. Mech Ageing Dev. 2008 Nov;129(11):666-70. doi: 10.1016/j.mad.2008.09.013. Epub 2008 Sep 30.
PubMed 18938195Thangaraj PM, Benson SH, Oikonomou EK, Asselbergs FW, Khera R. Cardiovascular care with digital twin technology in the era of generative artificial intelligence. Eur Heart J. 2024 Dec 1;45(45):4808-4821. doi: 10.1093/eurheartj/ehae619.
PubMed 39322420Corral-Acero J, Margara F, Marciniak M, Rodero C, Loncaric F, Feng Y, Gilbert A, Fernandes JF, Bukhari HA, Wajdan A, Martinez MV, Santos MS, Shamohammdi M, Luo H, Westphal P, Leeson P, DiAchille P, Gurev V, Mayr M, Geris L, Pathmanathan P, Morrison T, Cornelussen R, Prinzen F, Delhaas T, Doltra A, Sitges M, Vigmond EJ, Zacur E, Grau V, Rodriguez B, Remme EW, Niederer S, Mortier P, McLeod K, Potse M, Pueyo E, Bueno-Orovio A, Lamata P. The 'Digital Twin' to enable the vision of precision cardiology. Eur Heart J. 2020 Dec 21;41(48):4556-4564. doi: 10.1093/eurheartj/ehaa159.
PubMed 32128588Bjornsson B, Borrebaeck C, Elander N, Gasslander T, Gawel DR, Gustafsson M, Jornsten R, Lee EJ, Li X, Lilja S, Martinez-Enguita D, Matussek A, Sandstrom P, Schafer S, Stenmarker M, Sun XF, Sysoev O, Zhang H, Benson M; Swedish Digital Twin Consortium. Digital twins to personalize medicine. Genome Med. 2019 Dec 31;12(1):4. doi: 10.1186/s13073-019-0701-3.
PubMed 31892363
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Development and External Validation of a Multimodal Whole-Body Digital Twin for Quantification of Cross-Organ Physiologic Reserve, Recovery Dynamics, and Emerging Health-State Change
- ClinicalTrials.gov ID
- NCT07805044
- Acronym / sponsor ID
- TRU-OMNIBODY / TH-OMNIBODY-DT-2026-001
- Conditions
- PHYSIOLOGICAL PHENOMENA, Homeostasis, Physical Functional Performance, Cardiorespiratory Fitness, Cardiometabolic Risk Factors, Mobility Limitation
- Keywords
- Whole-Body Digital Twin, Physiologic Resilience, Whole-Body Recovery Burden, Patient-Specific Modeling, Computer Simulation, Artificial Intelligence, Machine Learning, Predictive Learning Models
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Truway Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 31 Mar 2039 (estimated)
- Study completion
- 30 Jun 2041 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference Health Cohort | – | Procedure: Standardized Physiologic Resilience Challenge, Other: Multimodal Whole-Body Physiologic Monitoring, Other: Research-Only Whole-Body Digital Twin AnalysisApproximately 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. |
| Stable Cardiometabolic Cohort | – | Procedure: Standardized Physiologic Resilience Challenge, Other: Multimodal Whole-Body Physiologic Monitoring, Other: Research-Only Whole-Body Digital Twin AnalysisApproximately 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. |
| Stable Respiratory or Mobility Cohort | – | Procedure: Standardized Physiologic Resilience Challenge, Other: Multimodal Whole-Body Physiologic Monitoring, Other: Research-Only Whole-Body Digital Twin AnalysisApproximately 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Physiologic Resilience ChallengeParticipants 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. | Procedure or surgery | Reference Health Cohort, Stable Cardiometabolic Cohort, Stable Respiratory or Mobility Cohort |
| Multimodal Whole-Body Physiologic MonitoringParticipants 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. | Other | Reference Health Cohort, Stable Cardiometabolic Cohort, Stable Respiratory or Mobility Cohort |
| Research-Only Whole-Body Digital Twin AnalysisA 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. | Other | Reference Health Cohort, Stable Cardiometabolic Cohort, Stable Respiratory or Mobility Cohort |
Primary outcome
Mean Absolute Prediction Error of the Locked Digital Twin for the 30-Minute Whole-Body Resilience Index
Time frame: 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.
6 secondary outcomes
Whole-Body Resilience Index at 30 Minutes After the Physiologic Challenge
Time frame: Thirty minutes after completion of the resilience challenge during the primary assessment visit.
Time to Multisystem Physiologic Recovery
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
Time frame: From the stabilized pre-challenge baseline through 30 minutes after completion of the resilience challenge.
Six-Minute Walk Distance
Time frame: Baseline (Day 1), during the primary assessment visit.
Cognitive-Motor Dual-Task Cost
Time frame: Baseline (Day 1), during the primary assessment visit.
Calibration Slope of the Locked Digital-Twin Prediction Model
Time frame: At each scheduled study assessment, from initiation of the assessment through 24 hours after completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 33948242Bent B, Wang K, Grzesiak E, Jiang C, Qi Y, Jiang Y, Cho P, Zingler K, Ogbeide FI, Zhao A, Runge R, Sim I, Dunn J. The digital biomarker discovery pipeline: An open-source software platform for the development of digital biomarkers using mHealth and wearables data. J Clin Transl Sci. 2020 Jul 14;5(1):e19. doi: 10.1017/cts.2020.511.
- Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 40088116Bandeen-Roche K, Zhu J, Xue QL, Buta B, Laskow T, Walston JD, Varadhan R. Characterization of Dynamic Adaptation to Stressors Using Multisystem Stimulus-Response Data: The Study of Physical Resilience in Aging Pilot. J Gerontol A Biol Sci Med Sci. 2025 May 5;80(6):glaf056. doi: 10.1093/gerona/glaf056.
- Background: PubMed 18938195Varadhan R, Seplaki CL, Xue QL, Bandeen-Roche K, Fried LP. Stimulus-response paradigm for characterizing the loss of resilience in homeostatic regulation associated with frailty. Mech Ageing Dev. 2008 Nov;129(11):666-70. doi: 10.1016/j.mad.2008.09.013. Epub 2008 Sep 30.
- Background: PubMed 39322420Thangaraj PM, Benson SH, Oikonomou EK, Asselbergs FW, Khera R. Cardiovascular care with digital twin technology in the era of generative artificial intelligence. Eur Heart J. 2024 Dec 1;45(45):4808-4821. doi: 10.1093/eurheartj/ehae619.
- Background: PubMed 32128588Corral-Acero J, Margara F, Marciniak M, Rodero C, Loncaric F, Feng Y, Gilbert A, Fernandes JF, Bukhari HA, Wajdan A, Martinez MV, Santos MS, Shamohammdi M, Luo H, Westphal P, Leeson P, DiAchille P, Gurev V, Mayr M, Geris L, Pathmanathan P, Morrison T, Cornelussen R, Prinzen F, Delhaas T, Doltra A, Sitges M, Vigmond EJ, Zacur E, Grau V, Rodriguez B, Remme EW, Niederer S, Mortier P, McLeod K, Potse M, Pueyo E, Bueno-Orovio A, Lamata P. The 'Digital Twin' to enable the vision of precision cardiology. Eur Heart J. 2020 Dec 21;41(48):4556-4564. doi: 10.1093/eurheartj/ehaa159.
- Background: PubMed 31892363Bjornsson B, Borrebaeck C, Elander N, Gasslander T, Gawel DR, Gustafsson M, Jornsten R, Lee EJ, Li X, Lilja S, Martinez-Enguita D, Matussek A, Sandstrom P, Schafer S, Stenmarker M, Sun XF, Sysoev O, Zhang H, Benson M; Swedish Digital Twin Consortium. Digital twins to personalize medicine. Genome Med. 2019 Dec 31;12(1):4. doi: 10.1186/s13073-019-0701-3.
- Truway Health Clinical Trials and Research InformationLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gavin C Solomon, MD principal investigator
Truway Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PHYSIOLOGICAL PHENOMENA and Homeostasis, run by Truway Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Prediction Error of the Locked Digital Twin for the 30-Minute Whole-Body Resilience Index (time frame: During the primary assessment visit, from pre-challenge baseline through 30 minutes after completion of the resilience challenge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805044, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.