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

NCT07805044 | Enrolling By Invitation DMC

• 1 other identifier: TH-OMNIBODY-DT-2026-001
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mobility Limitation; PHYSIOLOGICAL PHENOMENA; Homeostasis; Physical Functional Performance; Cardiorespiratory Fitness; Cardiometabolic Risk Factors

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Thirty minutes after completion of the resilience challenge during the primary assessment visit.

• Time to Multisystem Physiologic Recovery

  From completion of the resilience challenge through 60 minutes of monitored recovery.

• Change in Multisystem Coordination Index From Baseline to 30-Minute Recovery

  From the stabilized pre-challenge baseline through 30 minutes after completion of the resilience challenge.

• Six-Minute Walk Distance

  Baseline (Day 1), during the primary assessment visit.

• Cognitive-Motor Dual-Task Cost

  Baseline (Day 1), during the primary assessment visit.

Other Outcomes (1)

• Participants Experiencing a Study-Procedure-Related Adverse Event

  From initiation of each study assessment through 24 hours after completion of that assessment.

Study Arms (3)

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.

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.

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.

Procedure: Standardized Physiologic Resilience Challenge; Other: Multimodal Whole-Body Physiologic Monitoring; Other: Research-Only Whole-Body Digital Twin Analysis

Interventions

Research-Only Whole-Body Digital Twin Analysis OTHER

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.

Reference Health Cohort; Stable Cardiometabolic Cohort; Stable Respiratory or Mobility Cohort

Standardized Physiologic Resilience Challenge PROCEDURE

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.

Reference Health Cohort; Stable Cardiometabolic Cohort; Stable Respiratory or Mobility Cohort

Multimodal Whole-Body Physiologic Monitoring OTHER

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.

Reference Health Cohort; Stable Cardiometabolic Cohort; Stable Respiratory or Mobility Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Truway Health, Inc.: lead

Study Sites (1)

Truway Health, Inc.

New York, New York, 10016, United States

Location

Related Publications (8)

• 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.

  PMID: 33948242 BACKGROUND

• Holland 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.

  PMID: 25359355 BACKGROUND

• ATS 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.

  PMID: 12091180 BACKGROUND

• Bandeen-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.

  PMID: 40088116 BACKGROUND

• Varadhan 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.

  PMID: 18938195 BACKGROUND

• Thangaraj 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.

  PMID: 39322420 BACKGROUND

• Corral-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.

  PMID: 32128588 BACKGROUND

• Bjornsson 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.

  PMID: 31892363 BACKGROUND

Related Links

• Truway Health Clinical Trials and Research Information

Biospecimen

Retention: SAMPLES WITH DNA

Retained biospecimens may include venous whole blood and blood-derived fractions, including serum, plasma, buffy coat, and peripheral blood mononuclear cells; saliva or buccal-cell specimens; and urine. DNA may be extracted from whole blood, buffy coat, peripheral blood mononuclear cells, saliva, or buccal cells for protocol-approved genomic analyses. Samples may support future research involving genomic, epigenomic, proteomic, metabolomic, and inflammatory markers related to physiologic resilience, recovery dynamics, and whole-body digital-twin development. No tissue biopsies or reproductive specimens are planned.

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gavin C Solomon, MD

  Truway Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): March 31, 2039
• Study Completion (Estimated): June 30, 2041
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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).

Locations

US (1)