Clinical trial NCT05326633: Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors
Official title: Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Critical Illness
Sarcopenia
ICU Acquired Weakness
Keywords: ICU Acquired Weakness
Critical Care
Long Term Acute Care Hospital
Protein
Neuromuscular electric stimulation
Physical Rehabilitation
Geriatric population
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. LTACH admission within 72 hours
2. Age ≥ 60 years old
3. Prior ICU stay ≥ 2 weeks
4. Able to follow commands in English
5. Pre-ICU Barthel Index ≥ 70
6. Able to give consent
7. Able to perform physical therapy
8. All four limbs intact and mobile prior to LTACH admission

Exclusion Criteria:

1. Acute kidney injury with a glomerular filtration rate \<15 ml/min
2. Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
3. Diagnosis of active cancer
4. Severe functional impairment or physical impairment to rehabilitation
5. Liver function tests \>2.5x normal limits
6. Chronic dementia or cognitive impairment

Primary outcomes:
measure: Change in Muscle mass
timeFrame: Days 0 to 14 to 28
measure: Change in Muscle strength
timeFrame: Days 0, 7, 14, 21 and 28
measure: Change in Systemic Inflammation
timeFrame: Days 0, 7, 14, 21 and 28
Secondary outcomes:
measure: Change in Functional status - SPPB
timeFrame: Days 0, 7, 14, 21 and 28
measure: Change in Functional status - FSS-ICU
timeFrame: Days 0, 7, 14, 21 and 28
measure: Change in Mobility status - ICU mobility Scale
timeFrame: Days 0, 7, 14, 21 and 28
measure: Change in Mobility status - 6 minute walk distance
timeFrame: Days 0, 7, 14, 21 and 28
measure: Change in Mobility status - gait speed
timeFrame: Days 0, 7, 14, 21 and 28
measure: Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death)
timeFrame: up to or after Day 28
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: U of Maryland, Baltimore, Professional Schools IRB
state: Maryland
Study officials:
References: