Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patients Outcomes

Running, not enrolling · Not applicable

Conditions studied: Muscle Weakness, Critical Illness, Sarcopenia

In brief

Elderly patients who experience a prolonged ICU stay are at high risk for developing post intensive care unit syndrome (PICS), a serious medical condition manifested by loss of muscle mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic disability, prolonged mechanical ventilation and the need for costly extended stays in long term care facilities (LTCs). The investigators' preliminary study shows attempts at rehabilitating patients who have already developed PICS are minimally effective, resulting in only modest improvements in functionality. This project will determine the effects of mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on preventing PICS related musculoskeletal and functional deficits, and improving clinical outcomes.

Key facts

Study ID

NCT02509520

Run by

University of Maryland, Baltimore

People needed

60

Starts

2015-05-01

Expected to finish

2027-05-01

Last updated by the study team

2026-07-02

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 45 years
• Respiratory insufficiency requiring mechanical ventilation (MV)
• ICU presentation < 6 days
• Patient or legally authorized representative able to provide written or witnessed verbal informed consent in English
• All four limbs intact and mobile
• Eligible for and able to participate in physical therapy
• Pre admission Barthel Index >70

You may not qualify if…

• Acute kidney injury with a glomerular filtration rate < 30 ml/min
• Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
• Diagnosis of active cancer
• Acute or chronic organ transplant rejection
• Exceedingly high mechanical ventilator settings (FiO2>60%, PEEP>12) or alternative modes of mechanical ventilation (inverse ratio pressure control, airway pressure release ventilation)
• Severe functional impairment or physical impairment to rehabilitation
• On high dose vasopressor agents (> 5mcg of norepinephrine or equivalent)
• Liver function tests > 2.5 x normal limits (normal reference ranges include AST between 10 and 40 units/L or ALT between 7 and 56 units/L)
• Chronic dementia or cognitive impairment

Where it is running

• U of Maryland, Baltimore, Professional Schools IRB — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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