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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05326633
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Critical Illness
  • ICU Acquired Weakness
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
60 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES) — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2027
Status verified
Apr 2026
Primary completion
Jan 30, 2029
Completion
Oct 30, 2029

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Change in Muscle mass [ Time Frame: Days 0 to 14 to 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
U of Maryland, Baltimore, Professional Schools IRBBaltimoreMaryland21201
Avelino C Verceles, MD, MS
[email protected]
410-328-8141

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By research site
U of Maryland, Baltimore, Professional Schools IRB· Baltimore, MD

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