Exercise + Protein + Electric Stimulation for Muscle Weakness

(ExPrEs Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: High dose vasopressors

Disqualifiers: Acute kidney injury, Severe organ dysfunction, Active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 14 days

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for ICU patients aged 45 or older who are on mechanical ventilation but can still do physical therapy. They should have been in the ICU for less than 6 days, be able to consent, and have a decent level of independence before admission. People with severe organ failure, active cancer, high ventilator settings, cognitive impairments or on high dose vasopressors cannot join.

Inclusion Criteria

I was admitted to the ICU less than 6 days ago.

I am 45 years old or older.

I can do most daily activities by myself.

Exclusion Criteria

Your liver function tests show that your liver may not be working properly.

I am on very high settings on a breathing machine or using a special type of breathing support.

I have chronic dementia or cognitive issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation (NMES) and high protein supplementation (HPRO) during their ICU stay

14 days

Daily interventions during ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including muscle mass, strength, and mobility assessments

30 days

Assessments at 7 and 14 days, and discharge disposition at 30 days

Treatment Details

Interventions

• High Protein Supplement (HPRO)
• Mobility-based Physical Rehabilitation (MPR)
• Neuromuscular Electric Stimulation (NMES)

Trial Overview The study tests if starting mobility-based exercises (MPR), muscle stimulation (NMES), and extra protein early during an ICU stay can prevent muscle loss and weakness associated with PICS. It aims to see if these interventions improve overall recovery and reduce long-term disability.

Participant Groups

Group I: Mobility-based Physical Rehab (MPR) Active Control 1 Intervention

ICU control group receiving only mobility based rehabilitation (MPR).

Group II: MPR and Neuromuscular Stimulation and HPRO Active Control 1 Intervention

ICU group receiving mobility based rehabilitation and NMES and High protein supplementation.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+