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

Critical Illness Clinical Trial

— ProMoTE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05326633
• Other study ID #: HP-00083098
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: October 1, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: Avelino C Verceles, M.D., M.S.
• Phone: 410-328-8141
• Email: avercele[@]medicine.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: May 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• ICU Acquired Weakness
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
United States	U of Maryland, Baltimore, Professional Schools IRB	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Systemic Inflammation	Quantitative analysis of CRP, IFN-?, IL-1a, IL-1ß, IL-6, and IL-8.	Days 0, 7, 14, 21 and 28
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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