Combined Rehab Therapy for Acquired Weakness

(ProMoTE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Maryland, Baltimore

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for older ICU survivors aged 60 or above who have been weakened by their stay. They must have been in the ICU for at least two weeks, be able to understand and follow instructions in English, consent to participate, and were mobile before their recent hospital admission. Those with severe organ dysfunction, active cancer, chronic dementia, acute kidney injury or extreme liver issues cannot join.

Inclusion Criteria

I have stayed in the ICU for 2 weeks or more.

Able to give consent

I am 60 years old or older.

Exclusion Criteria

I have severe physical or functional limitations.

I have severe liver problems, including end-stage disease or cirrhosis.

I have been diagnosed with active cancer.

Participant Groups

The study tests a recovery program combining mobility exercises (MRP), high protein supplements (HPRO), and electric muscle stimulation (NMES) on patients who've lost strength after an ICU stay. It aims to see if this combination helps improve physical function and reduces inflammation-related disability.

Group I: MRP+HPRO+NMES+UC Active Control 1 Intervention

LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)

Group II: UC only Active Control 1 Intervention

LTACH control group receiving usual care (UC) only.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

U of Maryland, Baltimore, Professional Schools IRB Baltimore, MD

Who Is Running the Clinical Trial?

University of Maryland, Baltimore Lead Sponsor

References