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Exercise + Protein + Electric Stimulation for Muscle Weakness (ExPrEs Trial)
N/A
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a combination of physical rehabilitation, electrical stimulation, and high protein supplementation can prevent post-intensive care unit syndrome, a condition characterized by muscle loss, weakness, and cognitive decline.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from exercise or electric stimulation, possible skin irritation at the NMES application site, and digestive issues due to high protein intake.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Global body strength
Mobility status
Muscle mass
+1 moreSecondary study objectives
Discharge disposition
ICU/Hospital length of stay
Time to weaning
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Mobility-based Physical Rehab (MPR)Active Control1 Intervention
ICU control group receiving only mobility based rehabilitation (MPR).
Group II: MPR and Neuromuscular Stimulation and HPROActive Control1 Intervention
ICU group receiving mobility based rehabilitation and NMES and High protein supplementation.
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
379,192 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have severe liver problems, including end-stage disease or cirrhosis.My kidney function is severely reduced.I have been diagnosed with active cancer.I was admitted to the ICU less than 6 days ago.My body is rejecting an organ transplant.I am 45 years old or older.I have severe physical or functional limitations.I can do most daily activities by myself.I am on a high dose of medication to raise my blood pressure.I need a machine to help me breathe.I can move all of my arms and legs.I can take part in physical therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Mobility-based Physical Rehab (MPR)
- Group 2: MPR and Neuromuscular Stimulation and HPRO
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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