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

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ClinicalTrials.gov Identifier: NCT02509520
Recruitment Status : Active, not recruiting
First Posted : July 28, 2015
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Avelino Verceles, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Muscle Weakness Critical Illness Sarcopenia Dietary Supplement: MPR and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES) Not Applicable

Detailed Description:

Older, critically ill patients who survive their ICU stay frequently develop post-ICU syndrome (PICS) - a condition manifested by sarcopenia, weakness, malnutrition and neurocognitive decline - which occurs as a result of a critical illness, prolonged bed rest, catabolism, and polypharmacy. PICS frequently leads to chronic disability, prolonged mechanical ventilation (MV), functional deficits, and the need for extended rehabilitation in long term care facilities (LTCs). As the majority of patients admitted to ICUs are ≥ 65 years old, many of these patients are at high risk for PICS. Since the care of ICU patients is primarily focused on the medical management of the acute critical illness, there are limited resources and strategies available to prevent PICS. Evidence suggests mobility-based physical rehabilitation (MPR) combined with resistive training with neuromuscular electric stimulation (NMES) and high protein diets (HPRO) containing essential amino acids can mitigate the loss of muscle mass and function during bed rest in the elderly. The investigators hypothesize that preventive therapy involving the addition of both NMES and HPRO to MPR early and throughout the ICU and hospital stay can mitigate PICS-associated sarcopenia, malnutrition, and immobility to confer valuable health benefits toward recovery. To test this, the investigators will use a 2x2 factorial design in which older, MV ICU patients will all receive comprehensive ICU care and MPR, then be randomized to one of 4 groups: 1) MPR+NMES, 2) MPR+HPRO, 3) all 3 together, or 4) MPR alone (control), to determine independent and combined effects of the interventions.

The Specific Aims are to 1) determine the effects of adding NMES and HPRO interventions to MPR on muscle mass, strength, and mobility function in older, critically ill MV patients while still in the ICU, and 2) determine the effects of adding NMES and HPRO interventions to MPR on the clinical outcomes of time to weaning from MV, ICU/hospital length of stay and discharge disposition of these patients.

This proposal capitalizes on the interdisciplinary collaboration among Pulmonary/Critical Care Intensivists, Physical Therapists, Geriatricians, Clinical Nutritionists, Statisticians and Nutrition and Metabolism clinical researchers examining the efficacy of the proposed comprehensive rehabilitation approach. The investigators' primary goal is to attenuate the severity of sarcopenia and functional decline in this older, critically ill population at risk for severe disability. Additionally, by focusing on maintaining skeletal muscle mass, function, and strength, the investigators hope to improve clinical outcomes. The investigators posit this combined therapy will mitigate PICS-associated disability and speed the recovery from critical illness in older, MV ICU patients. This project has high overall impact as the intervention is easily administered by hospital staff and may greatly reduce the physiological and functional declines while hastening recovery during acute ICU hospitalization in older adults.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rehabilitation, NMES and High Protein to Reduce Post ICU Syndrome in the Elderly
Study Start Date : May 1, 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Mobility-based Physical Rehab (MPR)
ICU control group receiving only mobility based rehabilitation (MPR).
Active Comparator: MPR and Neuromuscular Stimulation and HPRO
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)
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.




Primary Outcome Measures :
  1. Muscle mass [ Time Frame: 14 days ]
    Muscle mass as measured by lower extremity muscle volume

  2. Global body strength [ Time Frame: 14 days ]
    Muscle group strength as measured by hand held dynamometer and by hand grip strength

  3. Mobility status [ Time Frame: 14 days ]
    Outcome as measured by combined 6 minute walk distance and gait speed

  4. Short Physical Performance Battery [ Time Frame: 14 days ]
    Short Physical Performance battery will be assessed at baseline and at 7 and 14 days.


Secondary Outcome Measures :
  1. Time to weaning [ Time Frame: 14 days ]
    As measured by ventilator days

  2. ICU/Hospital length of stay [ Time Frame: 14 days ]
    Days in the ICU, days in the hospital

  3. Discharge disposition [ Time Frame: 30 days ]
    home, nursing home, acute rehabilitation, readmission, death, remains hospitalized

  4. Weaning success [ Time Frame: 14 days ]
    proportion of patient successfully weaned with in a 14 day period, and eventually



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509520


Locations
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United States, Maryland
U of Maryland, Baltimore, Professional Schools IRB
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland

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Responsible Party: Avelino Verceles, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT02509520     History of Changes
Other Study ID Numbers: 00056749
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Avelino Verceles, University of Maryland:
Nutritional supplementation
Neuromuscular Electric Stimulation
ICU acquired weakness
Post ICU Syndrome
sarcopenia

Additional relevant MeSH terms:
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Critical Illness
Sarcopenia
Muscle Weakness
Paresis
Disease Attributes
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases