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

NCT ID: NCT05326633

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-05-30

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.

Conditions

Critical Illness; Sarcopenia; ICU Acquired Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

UC only

LTACH control group receiving usual care (UC) only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

MRP+HPRO+NMES+UC

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

Group Type: ACTIVE_COMPARATOR

MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Avelino Verceles

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

U of Maryland, Baltimore, Professional Schools IRB

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Avelino C Verceles, M.D., M.S.

Role: CONTACT

avercele@medicine.umaryland.edu

410-328-8141

Facility Contacts

Avelino C Verceles, MD, MS

Role: primary

avercele@medicine.umaryland.edu

410-328-8141

Other Identifiers

HP-00083098

Identifier Type: -

Identifier Source: org_study_id