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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Sarcopenia; ICU Acquired Weakness
• Intervention / Treatment: Combination product: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)

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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Avelino C Verceles, M.D., M.S.; Phone Number: 410-328-8141; Email: avercele@medicine.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • U of Maryland, Baltimore, Professional Schools IRB
      • Contact: Avelino C Verceles, MD, MS; Phone Number: 410-328-8141; Email: avercele@medicine.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: UC only; LTACH control group receiving usual care (UC) only.
Active Comparator: MRP+HPRO+NMES+UC; LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle mass	Muscle mass will be measured by lower extremity muscle CT scans to calculate muscle volume and cross sectional area.	Days 0 to 14 to 28
Change in Muscle strength	Handgrip strength obtained using a hand grip dynamometer and manual muscle testing using hand held dynamometer	Days 0, 7, 14, 21 and 28
Change in Systemic Inflammation	Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.	Days 0, 7, 14, 21 and 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional status - SPPB	Functional status will be assessed by using the Short Physical Performance Battery (SPPB)	Days 0, 7, 14, 21 and 28
Change in Functional status - FSS-ICU	Functional status will be assessed by using the Functional Status Score in the ICU (FSS-ICU).	Days 0, 7, 14, 21 and 28
Change in Mobility status - ICU mobility Scale	Mobility status will be assessed weekly using the 1-item ICU Mobility Scale weekly in those physically capable.	Days 0, 7, 14, 21 and 28
Change in Mobility status - 6 minute walk distance	Mobility status will be assessed weekly using the total 6 Minute Walk distance in those physically capable.	Days 0, 7, 14, 21 and 28
Change in Mobility status - gait speed	Mobility status will be assessed weekly using gait speed in those physically capable.	Days 0, 7, 14, 21 and 28
Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death)	Discharge disposition from the LTACH to home, nursing home, acute rehabilitation, readmission, or death)	up to or after Day 28

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Protein; Critical Care; Physical Rehabilitation; ICU Acquired Weakness; Long Term Acute Care Hospital; Neuromuscular electric stimulation; Geriatric population
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Critical Illness
• Other Study ID Numbers: HP-00083098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No