Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES).
- Who it may be relevant to
- Registry conditions: Critical Illness, Sarcopenia, ICU Acquired Weakness. Basic parameters: 60 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness
Overview
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.
Interventions
- Combination product MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)
Mobility-based physical rehabilitation sessions performed 5 times/week by a study PT to provide strength and cardiopulmonary endurance training. High whey protein shakes prescribed to a total intake of 1.6-1.8 g/kg/d in 2 divided doses based on caloric needs. 2 x 30-minute lower extremity electric stimulation sessions/day, 5 times/wk performed by study PT.
Primary outcome measures
- Change in Muscle mass [Time frame: Days 0 to 14 to 28]
- Change in Muscle strength [Time frame: Days 0, 7, 14, 21 and 28]
- Change in Systemic Inflammation [Time frame: Days 0, 7, 14, 21 and 28]
Secondary outcome measures (6)
- Change in Functional status - SPPB [Time frame: Days 0, 7, 14, 21 and 28]
- Change in Functional status - FSS-ICU [Time frame: Days 0, 7, 14, 21 and 28]
- Change in Mobility status - ICU mobility Scale [Time frame: Days 0, 7, 14, 21 and 28]
- Change in Mobility status - 6 minute walk distance [Time frame: Days 0, 7, 14, 21 and 28]
- Change in Mobility status - gait speed [Time frame: Days 0, 7, 14, 21 and 28]
- Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death) [Time frame: up to or after Day 28]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- U of Maryland, Baltimore, Professional Schools IRB — Baltimore
Identifiers
NCT: NCT05326633 · HP-00083098