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Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness
Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. To address the sequalae of critical illnesses, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO), and neuromuscular electric stimulation (NMES). The investigators will then assess both clinical and functional outcomes and determine the relationship of disability with systemic inflammation.
Annually, nearly 3 million patients ≥ 65 years old are admitted to intensive care units (ICUs) nationwide, 20% of whom experience a long, protracted ICU stay resulting in muscle deconditioning, atrophy, inflammation, and functional disability necessitating transfer from the ICU to a long term acute care hospitals (LTACH). In the LTACH exacerbations of chronic comorbidities and the cycle of prolonged bed rest, ongoing inflammation and malnutrition often leads to continued functional disability, immobility, prolonged mechanical ventilation and increased one-year mortality of up to 25%. After a patient has survived critical illness and is transferred to an LTACH facility, one of the major challenges of their continued care is how to address - and ameliorate - their profound physical and functional deficits. To address these sequalae of chronic critical illness, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO) and neuromuscular electric stimulation (NMES) to assess both clinical and functional outcomes and to determine the relationship of disability with systemic inflammation. The investigators will prospectively randomize patient to receive our multicomponent intervention or usual care and assess the outcomes of functional mobility, change in muscle mass and discharge disposition. Additionally, the investigators will determine the effects of our intervention on inflammatory cytokine profiles to determine to what degree systemic inflammation mediates clinical recovery.
Age
60 - 99 years
Sex
ALL
Healthy Volunteers
No
U of Maryland, Baltimore, Professional Schools IRB
Baltimore, Maryland, United States
Start Date
December 1, 2025
Primary Completion Date
January 30, 2027
Completion Date
May 30, 2027
Last Updated
July 15, 2025
78
ESTIMATED participants
MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)
COMBINATION_PRODUCT
Lead Sponsor
University of Maryland, Baltimore
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05884138