Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors

Официальное название

Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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.

Первичные конечные точки

• Change in Muscle mass [Срок оценки: Days 0 to 14 to 28]
• Change in Muscle strength [Срок оценки: Days 0, 7, 14, 21 and 28]
• Change in Systemic Inflammation [Срок оценки: Days 0, 7, 14, 21 and 28]

Вторичные конечные точки (6)

• Change in Functional status - SPPB [Срок оценки: Days 0, 7, 14, 21 and 28]
• Change in Functional status - FSS-ICU [Срок оценки: Days 0, 7, 14, 21 and 28]
• Change in Mobility status - ICU mobility Scale [Срок оценки: Days 0, 7, 14, 21 and 28]
• Change in Mobility status - 6 minute walk distance [Срок оценки: Days 0, 7, 14, 21 and 28]
• Change in Mobility status - gait speed [Срок оценки: Days 0, 7, 14, 21 and 28]
• Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death) [Срок оценки: up to or after Day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

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

Идентификаторы

NCT: NCT05326633 · HP-00083098

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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