跳至主要内容
临床试验/NCT05326633
NCT05326633尚未招募早期 1 期

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

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2027年3月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
78
试验地点
2
主要终点
Change in Muscle mass

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

UC only

No Intervention

LTACH control group receiving usual care (UC) only.

MRP+HPRO+NMES+UC

Active Comparator

LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)

干预措施: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES) (Combination Product)

结局指标

主要结局

Change in Muscle mass

时间窗: 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

时间窗: 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

时间窗: Days 0, 7, 14, 21 and 28

Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Avelino Verceles

Professor

University of Maryland, Baltimore

研究点 (2)

Loading locations...

相似试验