Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patients Outcomes

NCT02509520 | Active Not Recruiting DMC

• 1 other identifier: 00056749
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients who experience a prolonged ICU stay are at high risk for developing post intensive care unit syndrome (PICS), a serious medical condition manifested by loss of muscle mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic disability, prolonged mechanical ventilation and the need for costly extended stays in long term care facilities (LTCs). The investigators' preliminary study shows attempts at rehabilitating patients who have already developed PICS are minimally effective, resulting in only modest improvements in functionality. This project will determine the effects of mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on preventing PICS related musculoskeletal and functional deficits, and improving clinical outcomes.

Conditions

Muscle Weakness; Critical Illness; Sarcopenia

Keywords

Nutritional supplementation; Neuromuscular Electric Stimulation; ICU acquired weakness; Post ICU Syndrome; sarcopenia

Outcome Measures

Primary Outcomes (4)

• Muscle mass

  Muscle mass as measured by lower extremity muscle volume

  14 days

• Global body strength

  Muscle group strength as measured by hand held dynamometer and by hand grip strength

  14 days

• Mobility status

  Outcome as measured by combined 6 minute walk distance and gait speed

  14 days

• Short Physical Performance Battery

  Short Physical Performance battery will be assessed at baseline and at 7 and 14 days.

  14 days

Secondary Outcomes (4)

• Time to weaning

  14 days

• ICU/Hospital length of stay

  14 days

• Discharge disposition

  30 days

• Weaning success

  14 days

Study Arms (2)

Mobility-based Physical Rehab (MPR)

NO INTERVENTION

ICU control group receiving only mobility based rehabilitation (MPR).

MPR and Neuromuscular Stimulation and HPRO

ACTIVE COMPARATOR

ICU group receiving mobility based rehabilitation and NMES and High protein supplementation.

Dietary Supplement: MPR and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)

Interventions

MPR and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES) DIETARY_SUPPLEMENT

The MPR provides strength and cardiopulmonary endurance training, which consist of exercises to promote function movements. Intensity is based on patient's hemodynamic responses and subjective report using Modified Borg Dyspnea Scale. Intensity, duration, or type of activity will be modified each session to achieve a moderately intense physiologic response. The NMES protocol requires self-adhesive surface electrodes be placed on quadriceps muscles and lower leg bilaterally, twice daily. This protocol is based on prior NMES protocols used to stimulate muscle protein synthesis in older diabetic patients, preserve muscle mass in intensive care patients and increase strength in older adults after knee replacement. The HPRO intervention is based on caloric needs, calculated using validated equations to maintain positive nitrogen balance. Protein will be supplemented as isolated amino acids twice/day to deliver \~15g of essential amino acids per serving, with a goal of 1.6 g/kg/day.

MPR and Neuromuscular Stimulation and HPRO

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45 years
• Respiratory insufficiency requiring mechanical ventilation (MV)
• ICU presentation \< 6 days
• Patient or legally authorized representative able to provide written or witnessed verbal informed consent in English
• All four limbs intact and mobile
• Eligible for and able to participate in physical therapy
• Pre admission Barthel Index \>70

You may not qualify if:

• Acute kidney injury with a glomerular filtration rate \< 30 ml/min
• Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
• Diagnosis of active cancer
• Acute or chronic organ transplant rejection
• Exceedingly high mechanical ventilator settings (FiO2\>60%, PEEP\>12) or alternative modes of mechanical ventilation (inverse ratio pressure control, airway pressure release ventilation)
• Severe functional impairment or physical impairment to rehabilitation
• On high dose vasopressor agents (\> 5mcg of norepinephrine or equivalent)
• Liver function tests \> 2.5 x normal limits (normal reference ranges include AST between 10 and 40 units/L or ALT between 7 and 56 units/L)
• Chronic dementia or cognitive impairment

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

U of Maryland, Baltimore, Professional Schools IRB

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Verceles AC, Serra M, Davis D, Alon G, Wells CL, Parker E, Sorkin J, Bhatti W, Terrin ML. Combining exercise, protein supplementation and electric stimulation to mitigate muscle wasting and improve outcomes for survivors of critical illness-The ExPrES study. Heart Lung. 2023 Mar-Apr;58:229-235. doi: 10.1016/j.hrtlng.2022.11.013. Epub 2022 Dec 5.

  PMID: 36473808 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Critical Illness; Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Muscular Atrophy; Atrophy; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 28, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)