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RecruitingNCT05537298TRACERUpdated Jun 26, 2026

Muscle Recovery After Critical Illness

An observational study in ICU Acquired Weakness, Post Intensive Care Unit Syndrome and Muscle Weakness, sponsored by Esther Dupont-Versteegden. Recruiting at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Esther Dupont-Versteegden · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
209
Ages
18 Years and older
Sex
Male
01

Study summary

The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness:

  1. to examine the recovery of muscle and physical function in ICU survivors through longitudinal assessments
  2. to investigate the underlying cellular markers and mechanisms of muscle recovery in ICU survivors
  3. to determine which cellular markers contribute to physical disability in ICU survivors up to 1 year after hospital admission
Read the detailed description

Patients surviving critical illness develop significant impairments in skeletal muscle, commonly referred to as ICU-acquired weakness (ICUAW)[8-10]. It is estimated that up to 70-80% of patients admitted to ICU will develop some degree of neuromuscular dysfunction, weakness, myopathy or atrophy [11,12]. ICUAW encompasses muscle impairments that develop as a direct result of admission for critical illness[13] and is an independent predictor of mortality and long-term functional impairments[14-19]. Interventions to mitigate muscle deficits and improve physical function are a critical area of rehabilitation because of the high prevalence of short- and long-term impairments. ICU survivorship is particularly important as roughly 6 million Americans will survive an acute admission to the ICU this year alone.[24-26] Survivors of critical illnesses such as sepsis, viral-illnesses including coronaviruses, and acute respiratory failure (ARF) have reduced quality of life, lost wages from inability to return to work and increased caregiver and healthcare burden for years after hospital discharge.[27-31] Impairments in skeletal muscle are known contributors to physical disability and specifically prevent the performance of simple daily life activities like standing up from a chair. However, very little is known about cellular mechanisms leading to muscle and physical dysfunction in patients surviving critical illness during recovery. These gaps in knowledge are significant because identifying the phenotypes and underlying cellular mechanisms that lead to impaired muscle and physical function will facilitate the development of pharmacologic and non-pharmacologic interventions to mitigate or reverse disability. From a scientific perspective, this proposal is noteworthy because it will be the first to assess muscle protein synthesis rates in combination with cellular phenotypes, muscle strength, and physical function in patients recovering from an ICU admission. Studying muscle at the cellular level and integrating that knowledge with physical function will help improve our understanding of why certain patients fail to recover.

Elucidating cellular mechanisms during recovery phase will provide the framework to develop interventions in subsequent studies. We will assess measures of muscle and physical function in the first year of recovery to establish why some patients have restored function, yet others have sustained disability. Improved classification of muscle dysfunction and physical function enables future studies to employ a targeted approach instead of the historical rehabilitation approach of one-size-fits-all. Specifically, the cellular findings will lead to development of novel interventions specifically designed for the underlying mechanisms, while identification of the recovery trajectories will enhance clinicians' ability to implement interventions to patients with the greatest need.

02

Conditions studied

  • ICU Acquired Weakness
  • Post Intensive Care Unit Syndrome
  • Muscle Weakness
  • Critical Illness

Keywords

  • skeletal muscle
  • physical function
03

In context

Muscle Weakness

477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.

This study's planned enrollment of 209 is above the median of 68 across 108 observational studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

Esther Dupont-Versteegden is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

Patients admitted to ICU for critical illness and expected to survive

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.

Inclusion criteria

  • adult (>18 y/o)
  • admission for sepsis or acute respiratory failure with at least 72 hour stay in ICU

Exclusion criteria

Exclusion Criteria:

  • patients who were not ambulatory prior to ICU admission
  • experienced >2 ICU admissions in the past year (chronic or recurrent critical illness due to the same or different reason
  • patients not expected to survive \~6months after admission
  • acute or chronic neurologic condition
  • acute or chronic orthopedic condition preventing strength/functional testing
  • morbid obesity >50 kg/m2 due to distortion of muscle ultrasonography
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
209 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Survivor

    Patients (n = 209) surviving critical illness will be enrolled to longitudinal, observational study examining muscle strength, power, and fatigue as well as physical function at hospital discharge and repeated at 3-, 6-, and 12-month following. A subset of individuals (n =32) will undergo muscle biopsies and blood will be collected.

  • Control

    A group of healthy controls will be recruited to serve as comparator to measures of strength, power, physical function, and muscle tissue analyses. Controls will participate in a one-time assessment.

06

What researchers measure

Primary outcomes

  1. Physical function

    Short Physical Performance Battery

    Time frame: the change from baseline to 12-months

  2. Mitochondrial function

    muscle mitochondrial respirometry

    Time frame: the change from baseline to 12-months

  3. Muscle power

    lower-extremity muscle power (unilateral leg-press to record Watts)

    Time frame: the change from baseline to 12-months

Secondary outcomes

  1. Physical activity

    actigraphy measuring steps per day

    Time frame: the change from baseline to 12-months

  2. Functional mobility

    timed-up and go test

    Time frame: the change from baseline to 12-months

  3. Cardiopulmonary endurance / exercise capacity

    6-minute walk test

    Time frame: the change from baseline to 12-months

  4. self-reported health-related quality of life

    EuroQol-5Domains (EQ-5D) visual analog scale is a self-report of quality of life (0-100) with higher scores indicating a better perception of quality of life

    Time frame: the change from baseline to 12-months

  5. Muscle strength

    lower-extremity muscle strength measured by hand-held dynamometry (kilogram of force)

    Time frame: the change from baseline to 12-months

  6. Muscle morphology #1

    myofiber size

    Time frame: the change from baseline to 12-months

  7. Muscle morphology #2

    myofiber type

    Time frame: the change from baseline to 12-months

07

Study locations

1 of 3 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35005, United States
    Active, not recruiting

    Not enrolling at this site.

  • University of Kentucky
    Lexington, Kentucky 40536, United States
    Recruiting
    • Kirby Mayer, DPT, PhD · Contactkpmaye2@uky.edu · 8593233863
    • Esther E Dupont-Versteegden, PhD · Principal investigator
    • Ashley A Montgomery-Yates, MD · Sub investigator
    • Anna G. Kalema, MD · Sub investigator
    • Jamie L Sturgill, PhD · Sub investigator
    • Philip Kern, MD · Sub investigator
  • Oklahoma Medical Research Foundation
    Oklahoma City, Oklahoma 73113, United States
    Active, not recruiting

    Not enrolling at this site.

08

References and documents

Publications

  • Gonzalez-Seguel F, Summers LA, Fresenko LE, Long DE, Scott LN, Slone SA, Shankara Bhaktula S, Wen Y, Miller BF, Morris PE, Salyer AL, Kalema AG, Montgomery-Yates AA, Dupont-Versteegden EE, Mayer KP; TRACER study group Collaborators. Trajectories of Recovery after ACutE and cRitical illness (TRACER): a prospective observational study protocol. BMJ Open. 2025 Nov 19;15(11):e108885. doi: 10.1136/bmjopen-2025-108885. PubMed 41263932 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05537298
Lead sponsor
Esther Dupont-Versteegden
Responsible party
Esther Dupont-Versteegden (Professor, University of Kentucky) — Sponsor-investigator
First posted
Sep 13, 2022
Start date
Oct 18, 2022
Primary completion
Jul 2, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Jun 26, 2026

Study contacts

Kirby P Mayer, PhD
Contact
kpmaye2@uky.edu
859-218-0596
Doug Long, MS
Contact
delong2@uky.edu
859-32-5438
Kirby P Mayer, PhD
study director · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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