U of Maryland, Baltimore, Professional Schools IRB
Baltimore, Maryland, 21201, United States
NCT Number: NCT05326633
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.
Trial opening soon.
Get Notified60 year–99 year
All sexes
Interventional
Early Phase 1
Baltimore, Maryland, 21201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
Time frame: Days 0, 7, 14, 21 and 28
Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.
Time frame: Days 0, 7, 14, 21 and 28
Functional status will be assessed by using the Short Physical Performance Battery (SPPB)
Time frame: Days 0, 7, 14, 21 and 28
Functional status will be assessed by using the Functional Status Score in the ICU (FSS-ICU).
Time frame: Days 0, 7, 14, 21 and 28
Mobility status will be assessed weekly using the 1-item ICU Mobility Scale weekly in those physically capable.
Time frame: Days 0, 7, 14, 21 and 28
Mobility status will be assessed weekly using the total 6 Minute Walk distance in those physically capable.
Time frame: Days 0, 7, 14, 21 and 28
Mobility status will be assessed weekly using gait speed in those physically capable.
Time frame: up to or after Day 28
Discharge disposition from the LTACH to home, nursing home, acute rehabilitation, readmission, or death)
Contact information is provided by the study sponsor or research team.
University of Maryland, Baltimore
Other
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness
Acronym: ProMoTE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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