Combined Rehab Therapy for Acquired Weakness

(ProMoTE Trial)

Overseen By Avelino C Verceles, M.D., M.S.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Maryland, Baltimore

Disqualifiers: Acute kidney injury, Severe organ dysfunction, Active cancer, Severe functional impairment, Chronic dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

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. ^{1 2 3 4 5}

Why 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. ^{2 3 6 7 8}

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

I have stayed in the ICU for 2 weeks or more.

Able to give consent

I am 60 years old or older.

Exclusion Criteria

I have severe physical or functional limitations.

I have severe liver problems, including end-stage disease or cirrhosis.

I have been diagnosed with active cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mobility-based physical rehabilitation, high protein supplementation, and neuromuscular electric stimulation

4 weeks

Weekly assessments

Follow-up

Participants are monitored for changes in mobility, muscle mass, muscle strength, and systemic inflammation

4 weeks

Weekly assessments

What Are the Treatments Tested in This Trial?

Interventions

• High Protein Supplement
• Mobility Therapy
• Neuromuscular Electric Stimulation

Trial Overview

The study tests a recovery program combining mobility exercises (MRP), high protein supplements (HPRO), and electric muscle stimulation (NMES) on patients who've lost strength after an ICU stay. It aims to see if this combination helps improve physical function and reduces inflammation-related disability.

How Is the Trial Designed?

Group I: MRP+HPRO+NMES+UC Active Control 1 Intervention

LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)

Group II: UC only Active Control 1 Intervention

LTACH control group receiving usual care (UC) only.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

In a study involving 20 healthy older men, neuromuscular electrical stimulation (NMES) applied before presleep protein ingestion significantly enhanced the incorporation of amino acids into muscle protein during overnight sleep by 18% compared to protein ingestion alone.

This suggests that combining NMES with dietary protein intake can be an effective strategy to counteract muscle atrophy during periods of disuse, such as bed rest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation prior to presleep protein feeding stimulates the use of protein-derived amino acids for overnight muscle protein synthesis. Dirks, ML., Groen, BB., Franssen, R., et al.[2018]

Neuromuscular electrical stimulation (NMES) therapy, when added to usual care, is effective in preventing skeletal-muscle weakness in critically ill patients, as shown in a systematic review of 8 studies involving 172 patients.

While NMES demonstrated benefits in preserving muscle strength, the evidence for its effectiveness in preventing muscle wasting remains inconclusive, with mixed results across the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation for preventing skeletal-muscle weakness and wasting in critically ill patients: a systematic review. Maffiuletti, NA., Roig, M., Karatzanos, E., et al.[2022]

Whey protein supplementation (WPS) was well tolerated and significantly increased daily protein intake in a study of 47 frail, hospitalized elderly individuals.

Participants receiving WPS showed notable improvements in grip strength and knee extensor force compared to the control group, indicating that WPS can enhance rehabilitation outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey Protein Supplementation Improves Rehabilitation Outcomes in Hospitalized Geriatric Patients: A Double Blinded, Randomized Controlled Trial. Niccoli, S., Kolobov, A., Bon, T., et al.[2018]

In a study involving 39 ICU patients, the combination of neuromuscular electrical stimulation (NMES), high protein supplementation (HPRO), and physical therapy (PT) significantly reduced lower extremity muscle loss compared to standard ICU care, as evidenced by CT imaging results.

Patients receiving NMES+HPRO+PT experienced less delirium and improved nitrogen balance, indicating better nutritional status, while there were no significant differences in length of stay or days on mechanical ventilation between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining exercise, protein supplementation and electric stimulation to mitigate muscle wasting and improve outcomes for survivors of critical illness-The ExPrES study. Verceles, AC., Serra, M., Davis, D., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11970806/

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We speculate that protein supplementation might reduce muscle protein breakdown, promote early activity, and be associated with improved ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0261561425000214

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pmc.ncbi.nlm.nih.gov

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022316625000240

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pmc.ncbi.nlm.nih.gov

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clinicalnutritionjournal.com/article/S0261-5614(21)00095-9/fulltext

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