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

Early Phase 1

Not yet recruiting

• Conditions: Sarcopenia; Critical Illness; ICU Acquired Weakness
• Interventions: Combination Product: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)

• Registration Number: NCT05326633
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-13
• Status Verified: 2024-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Study Start: 2025-12-01
• Primary Completion: 2027-01-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRP+HPRO+NMES+UC	MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)	LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)

Primary Outcome Measures

Name	Time	Method
Change in Muscle mass	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	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	Days 0, 7, 14, 21 and 28	Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.

Secondary Outcome Measures

Name	Time	Method
Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death)	up to or after Day 28	Discharge disposition from the LTACH to home, nursing home, acute rehabilitation, readmission, or death)
Change in Functional status - FSS-ICU	Days 0, 7, 14, 21 and 28	Functional status will be assessed by using the Functional Status Score in the ICU (FSS-ICU).
Change in Mobility status - 6 minute walk distance	Days 0, 7, 14, 21 and 28	Mobility status will be assessed weekly using the total 6 Minute Walk distance in those physically capable.
Change in Mobility status - ICU mobility Scale	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.
Change in Mobility status - gait speed	Days 0, 7, 14, 21 and 28	Mobility status will be assessed weekly using gait speed in those physically capable.
Change in Functional status - SPPB	Days 0, 7, 14, 21 and 28	Functional status will be assessed by using the Short Physical Performance Battery (SPPB)

Trial Locations

Locations (1)

U of Maryland, Baltimore, Professional Schools IRB; 🇺🇸 Baltimore, Maryland, United States