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

78 Participants Needed

Trial Summary

What is the purpose of this trial?

Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. To address the sequalae of critical illnesses, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO), and neuromuscular electric stimulation (NMES). The investigators will then assess both clinical and functional outcomes and determine the relationship of disability with systemic inflammation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Combined Rehab Therapy for Acquired Weakness?

Research shows that essential amino acids can help prevent muscle loss and improve strength in stroke patients, and neuromuscular electrical stimulation (NMES) can enhance muscle protein synthesis when combined with protein intake. These findings suggest that the components of the combined rehab therapy may be effective in improving muscle function and strength. ^{1 2 3 4 5}

Is Combined Rehab Therapy for Acquired Weakness safe for humans?

The studies show that combining neuromuscular electrical stimulation (NMES) with high protein supplementation is generally well tolerated and safe in elderly and hospitalized patients, improving muscle strength and rehabilitation outcomes without significant adverse effects. ^{4 6 7 8 9}

How does the Combined Rehab Therapy for Acquired Weakness differ from other treatments?

This treatment is unique because it combines high protein supplementation, mobility therapy, and neuromuscular electrical stimulation (NMES) to preserve muscle mass and function, which has not been assessed in ICU patients before. Unlike standard care, this approach aims to enhance muscle recovery by integrating nutritional support with physical and electrical muscle stimulation. ^{4 6 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Influence of essential amino acids on muscle mass and muscle strength in patients with cerebral stroke during early rehabilitation: protocol and rationale of a randomized clinical trial (AMINO-Stroke Study). [2019]

2. England pubmed.ncbi.nlm.nih.gov

Interventions to ameliorate reductions in muscle quantity and function in hospitalised older adults: a systematic review towards acute sarcopenia treatment. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial. [2010]

4. United States 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. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The combined intervention of neuromuscular electrical stimulation and nutrition therapy: A scoping review. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Supplementation with Whey Protein, Omega-3 Fatty Acids and Polyphenols Combined with Electrical Muscle Stimulation Increases Muscle Strength in Elderly Adults with Limited Mobility: A Randomized Controlled Trial. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

THE EFFECTS OF NEUROMUSCULAR ELECTRICAL STIMULATION IN ASSOCIATION WITH WHEY PROTEIN SUPPLEMENTATION AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Whey Protein Supplementation Improves Rehabilitation Outcomes in Hospitalized Geriatric Patients: A Double Blinded, Randomized Controlled Trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation for preventing skeletal-muscle weakness and wasting in critically ill patients: a systematic review. [2022]