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
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:
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.
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 →Esther Dupont-Versteegden is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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.
Exclusion Criteria:
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.
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.
Physical function
Short Physical Performance Battery
Time frame: the change from baseline to 12-months
Mitochondrial function
muscle mitochondrial respirometry
Time frame: the change from baseline to 12-months
Muscle power
lower-extremity muscle power (unilateral leg-press to record Watts)
Time frame: the change from baseline to 12-months
Physical activity
actigraphy measuring steps per day
Time frame: the change from baseline to 12-months
Functional mobility
timed-up and go test
Time frame: the change from baseline to 12-months
Cardiopulmonary endurance / exercise capacity
6-minute walk test
Time frame: the change from baseline to 12-months
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
Muscle strength
lower-extremity muscle strength measured by hand-held dynamometry (kilogram of force)
Time frame: the change from baseline to 12-months
Muscle morphology #1
myofiber size
Time frame: the change from baseline to 12-months
Muscle morphology #2
myofiber type
Time frame: the change from baseline to 12-months
Not enrolling at this site.
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Plan to share: Undecided
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Esther Dupont-Versteegden