Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Change in Muscle mass
- Status
- Not yet recruiting
- Last Updated
- 9 months ago
Overview
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 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.
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, 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.
Investigators
Avelino Verceles
Associate Professor
University of Maryland, Baltimore
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Change in Muscle mass
Time Frame: Days 0 to 14 to 28
Muscle mass will be measured by lower extremity muscle CT scans to calculate muscle volume and cross sectional area.
Change in Muscle strength
Time Frame: Days 0, 7, 14, 21 and 28
Handgrip strength obtained using a hand grip dynamometer and manual muscle testing using hand held dynamometer
Change in Systemic Inflammation
Time Frame: Days 0, 7, 14, 21 and 28
Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.
Secondary Outcomes
- Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death)(up to or after Day 28)
- Change in Functional status - FSS-ICU(Days 0, 7, 14, 21 and 28)
- Change in Mobility status - 6 minute walk distance(Days 0, 7, 14, 21 and 28)
- Change in Mobility status - ICU mobility Scale(Days 0, 7, 14, 21 and 28)
- Change in Mobility status - gait speed(Days 0, 7, 14, 21 and 28)
- Change in Functional status - SPPB(Days 0, 7, 14, 21 and 28)