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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 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

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 more
Secondary study objectives
Discharge disposition
ICU/Hospital length of stay
Time to weaning
+1 more

Awards & 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.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,054 Total Patients Enrolled

Media Library

High Protein Supplement (HPRO) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02509520 — N/A
Muscular Weakness Research Study Groups: Mobility-based Physical Rehab (MPR), MPR and Neuromuscular Stimulation and HPRO
Muscular Weakness Clinical Trial 2023: High Protein Supplement (HPRO) Highlights & Side Effects. Trial Name: NCT02509520 — N/A
High Protein Supplement (HPRO) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02509520 — N/A
~6 spots leftby Dec 2025
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