Status:
NOT_YET_RECRUITING
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Critical Illness
Sarcopenia
Eligibility:
All Genders
60-99 years
Phase:
EARLY_PHASE1
Brief Summary
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...
Detailed Description
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, atroph...
Eligibility Criteria
Inclusion
- LTACH admission within 72 hours
- Age ≥ 60 years old
- Prior ICU stay ≥ 2 weeks
- Able to follow commands in English
- Pre-ICU Barthel Index ≥ 70
- Able to give consent
- Able to perform physical therapy
- All four limbs intact and mobile prior to LTACH admission
Exclusion
- Acute kidney injury with a glomerular filtration rate \<15 ml/min
- Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
- Diagnosis of active cancer
- Severe functional impairment or physical impairment to rehabilitation
- Liver function tests \>2.5x normal limits
- Chronic dementia or cognitive impairment
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05326633
Start Date
December 1 2025
End Date
May 30 2027
Last Update
July 15 2025
Active Locations (1)
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1
U of Maryland, Baltimore, Professional Schools IRB
Baltimore, Maryland, United States, 21201