Combined Rehab Therapy for Acquired Weakness
(ProMoTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to help older adults who have become weak after a long ICU stay. The trial combines mobility-based physical rehabilitation, high-protein supplements, and neuromuscular electric stimulation, which uses electrical impulses to strengthen muscles. Researchers aim to determine if this approach can improve health and movement and explore how inflammation relates to disability. This study may suit individuals aged 60 or older who spent at least two weeks in the ICU, can move their arms and legs, and can follow commands in English. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to benefit from this innovative approach.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments in this trial are generally safe for participants.
For the high protein supplement, studies have found that increasing protein intake to 1.5 grams per kilogram of body weight per day is usually safe. This increase can improve nutrition and recovery for very sick individuals. However, some participants have experienced issues like high blood sugar and stomach problems.
Mobility therapy, which includes exercises to enhance movement, is also considered safe. It is crucial for those with muscle weakness after ICU stays. Regular movement can help prevent problems like muscle loss and confusion.
Neuromuscular electric stimulation (NMES) uses gentle electrical pulses to activate muscles and is another part of the trial. Studies show NMES is safe when administered by trained professionals. No reports of serious harm have emerged, though some minor side effects can occur.
Overall, these treatments are generally well-tolerated. The trial is in an early phase, focusing primarily on safety and the body's response to these treatments.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this combined rehab therapy for acquired weakness because it integrates multiple innovative approaches to enhance recovery. Unlike standard care, which often focuses on general physical therapy or nutritional support separately, this treatment combines high-protein supplementation, mobility therapy, and neuromuscular electric stimulation. These elements work synergistically to target muscle weakness from different angles—high-protein supplements support muscle repair, mobility therapy promotes functional movement, and electric stimulation activates muscle contraction. This comprehensive strategy could accelerate recovery and improve patient outcomes more effectively than existing treatments.
What evidence suggests that this trial's treatments could be effective for ICU acquired weakness?
Research has shown that high-protein supplements can help ICU patients with acquired weakness improve muscle strength and physical abilities. Studies indicate that increased protein intake can reduce muscle loss and speed up recovery. Early movement exercises, known as mobility therapy, lessen muscle weakness and improve breathing and mental health in ICU survivors. Neuromuscular electrical stimulation, which uses electrical impulses to help muscles contract, can also prevent muscle weakness and aid recovery for those leaving the ICU. In this trial, one group will receive a combination of mobility therapy, neuromuscular electrical stimulation, and high-protein supplementation, while another group will receive usual care. Together, these treatments offer promising ways to help older ICU survivors regain strength and function.23678
Are You a Good Fit for This Trial?
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
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, high protein supplementation, and neuromuscular electric stimulation
Follow-up
Participants are monitored for changes in mobility, muscle mass, muscle strength, and systemic inflammation
What Are the Treatments Tested in This Trial?
Interventions
- High Protein Supplement
- Mobility Therapy
- Neuromuscular Electric Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor