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

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status and phase

Begins enrollment in 3 months
Early Phase 1

Conditions

Critical Illness
ICU Acquired Weakness
Sarcopenia

Treatments

Combination Product: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)

Study type

Interventional

Funder types

Other

Identifiers

NCT05326633
HP-00083098

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 estimated patients

Sex

All

Ages

60 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

78 participants in 2 patient groups

UC only
No Intervention group
Description:
LTACH control group receiving usual care (UC) only.
MRP+HPRO+NMES+UC
Active Comparator group
Description:
LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)
Treatment:
Combination Product: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)

Trial contacts and locations

1

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Central trial contact

Avelino C Verceles, M.D., M.S.

Data sourced from clinicaltrials.gov

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