Exercise + Protein + Electric Stimulation for Muscle Weakness
(ExPrEs Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assist ICU patients at risk for developing post-intensive care unit syndrome (PICS), which can lead to muscle loss, weakness, and other health issues. Researchers seek to determine if early intervention with exercise, high-protein supplements (HPRO), and neuromuscular electric stimulation (NMES) can prevent these problems. The trial includes two groups: one receives only exercise, while the other receives exercise, protein supplements, and electric stimulation. Patients who have been on a ventilator in the ICU for less than six days and can participate in physical therapy might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery for future ICU patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this combination of treatments is safe for elderly ICU patients?
A previous study linked high protein supplements to better muscle function in patients with muscle weakness, such as those in the ICU. However, evidence remains limited regarding the best type of protein for these patients. Studies have shown that high protein intake holds promise in addressing muscle weakness associated with critical illness.
Research indicates that physical therapy focused on movement is crucial for patients with muscle weakness from ICU stays. This therapy can improve muscle strength and aid physical recovery after an ICU stay.
Studies have found neuromuscular electric stimulation (NMES) to be safe for critically ill patients. NMES can help prevent muscle weakness and may support early movement in the ICU.
Overall, these treatments—high protein supplements, physical therapy, and NMES—are generally safe and may help address muscle weakness in patients who have been in the ICU.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it combines several innovative approaches to tackle muscle weakness in ICU patients. Unlike standard care options, which often focus solely on physical therapy, this trial adds a high-protein supplement and neuromuscular electrical stimulation (NMES) to enhance muscle recovery. The high-protein supplement provides essential nutrients to aid muscle repair, while NMES delivers targeted electrical impulses to stimulate muscle contractions, potentially speeding up strength and mobility gains. Together, these treatments aim to offer a more comprehensive rehabilitation strategy, possibly leading to faster and more effective recovery outcomes for patients.
What evidence suggests that this trial's treatments could be effective for preventing PICS?
Research has shown that high-protein supplements can help older adults increase muscle size, improve the angle of muscle fibers, and strengthen grip. Protein intake also helps prevent muscle loss and frailty. In this trial, one group will receive mobility-based physical rehabilitation (MPR) alone, which can boost muscle strength and improve mobility, especially in the legs. Although early movement does not significantly increase muscle size, it enhances movement and reduces infections. Another group in this trial will receive a combination of MPR, high-protein supplements, and neuromuscular electrical stimulation (NMES). NMES can strengthen weak muscles and prevent further weakness in very ill patients. Together, these treatments may effectively address muscle weakness and aid recovery in patients at risk of post-intensive care syndrome (PICS).678910
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation (NMES) and high protein supplementation (HPRO) during their ICU stay
Follow-up
Participants are monitored for safety and effectiveness after treatment, including muscle mass, strength, and mobility assessments
What Are the Treatments Tested in This Trial?
Interventions
- High Protein Supplement (HPRO)
- Mobility-based Physical Rehabilitation (MPR)
- Neuromuscular Electric Stimulation (NMES)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor