Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors (ProMoTE)
Primary Purpose
Critical Illness, Sarcopenia, ICU Acquired Weakness
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring ICU Acquired Weakness, Critical Care, Long Term Acute Care Hospital, Protein, Neuromuscular electric stimulation, Physical Rehabilitation, Geriatric population
Eligibility Criteria
Inclusion Criteria:
- LTACH admission within 72 hours
- Age ≥ 60 years old
- Prior ICU stay ≥ 2 weeks
- Able to follow commands in English
- Pre-ICU Barthel Index ≥ 70
- Able to give consent
- Able to perform physical therapy
- All four limbs intact and mobile prior to LTACH admission
Exclusion Criteria:
- Acute kidney injury with a glomerular filtration rate <15 ml/min
- Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
- Diagnosis of active cancer
- Severe functional impairment or physical impairment to rehabilitation
- Liver function tests >2.5x normal limits
- Chronic dementia or cognitive impairment
Sites / Locations
- U of Maryland, Baltimore, Professional Schools IRB
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
UC only
MRP+HPRO+NMES+UC
Arm Description
LTACH control group receiving usual care (UC) only.
LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)
Outcomes
Primary Outcome Measures
Change in Muscle mass
Muscle mass will be measured by lower extremity muscle CT scans to calculate muscle volume and cross sectional area.
Change in Muscle strength
Handgrip strength obtained using a hand grip dynamometer and manual muscle testing using hand held dynamometer
Change in Systemic Inflammation
Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.
Secondary Outcome Measures
Change in Functional status - SPPB
Functional status will be assessed by using the Short Physical Performance Battery (SPPB)
Change in Functional status - FSS-ICU
Functional status will be assessed by using the Functional Status Score in the ICU (FSS-ICU).
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.
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.
Change in Mobility status - gait speed
Mobility status will be assessed weekly using gait speed in those physically capable.
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)
Full Information
NCT ID
NCT05326633
First Posted
February 7, 2022
Last Updated
August 28, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT05326633
Brief Title
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors
Acronym
ProMoTE
Official Title
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
January 30, 2026 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Sarcopenia, ICU Acquired Weakness
Keywords
ICU Acquired Weakness, Critical Care, Long Term Acute Care Hospital, Protein, Neuromuscular electric stimulation, Physical Rehabilitation, Geriatric population
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UC only
Arm Type
No Intervention
Arm Description
LTACH control group receiving usual care (UC) only.
Arm Title
MRP+HPRO+NMES+UC
Arm Type
Active Comparator
Arm Description
LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)
Intervention Type
Combination Product
Intervention Name(s)
MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Muscle mass
Description
Muscle mass will be measured by lower extremity muscle CT scans to calculate muscle volume and cross sectional area.
Time Frame
Days 0 to 14 to 28
Title
Change in Muscle strength
Description
Handgrip strength obtained using a hand grip dynamometer and manual muscle testing using hand held dynamometer
Time Frame
Days 0, 7, 14, 21 and 28
Title
Change in Systemic Inflammation
Description
Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.
Time Frame
Days 0, 7, 14, 21 and 28
Secondary Outcome Measure Information:
Title
Change in Functional status - SPPB
Description
Functional status will be assessed by using the Short Physical Performance Battery (SPPB)
Time Frame
Days 0, 7, 14, 21 and 28
Title
Change in Functional status - FSS-ICU
Description
Functional status will be assessed by using the Functional Status Score in the ICU (FSS-ICU).
Time Frame
Days 0, 7, 14, 21 and 28
Title
Change in Mobility status - ICU mobility Scale
Description
Mobility status will be assessed weekly using the 1-item ICU Mobility Scale weekly in those physically capable.
Time Frame
Days 0, 7, 14, 21 and 28
Title
Change in Mobility status - 6 minute walk distance
Description
Mobility status will be assessed weekly using the total 6 Minute Walk distance in those physically capable.
Time Frame
Days 0, 7, 14, 21 and 28
Title
Change in Mobility status - gait speed
Description
Mobility status will be assessed weekly using gait speed in those physically capable.
Time Frame
Days 0, 7, 14, 21 and 28
Title
Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death)
Description
Discharge disposition from the LTACH to home, nursing home, acute rehabilitation, readmission, or death)
Time Frame
up to or after Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
LTACH admission within 72 hours
Age ≥ 60 years old
Prior ICU stay ≥ 2 weeks
Able to follow commands in English
Pre-ICU Barthel Index ≥ 70
Able to give consent
Able to perform physical therapy
All four limbs intact and mobile prior to LTACH admission
Exclusion Criteria:
Acute kidney injury with a glomerular filtration rate <15 ml/min
Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
Diagnosis of active cancer
Severe functional impairment or physical impairment to rehabilitation
Liver function tests >2.5x normal limits
Chronic dementia or cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avelino C Verceles, M.D., M.S.
Phone
410-328-8141
Email
avercele@medicine.umaryland.edu
Facility Information:
Facility Name
U of Maryland, Baltimore, Professional Schools IRB
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avelino C Verceles, MD, MS
Phone
410-328-8141
Email
avercele@medicine.umaryland.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors
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