NMES for COPD and Pneumonia

Overseen By Stephanie Burns

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Disqualifiers: Frailty, BMI >40, ICU care, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

In older adults hospitalized for acute medical conditions, immobility, clinical treatments, and the illness itself contribute to physical deconditioning and delirium, hospital-acquired impairments that increase risk for long-term physical and mental disability, other morbidities, and death. In patients with acute respiratory failure, hospital-acquired functional impairments persist long after hospitalization, due to limited use to rehabilitative interventions in the inpatient or post-acute settings. Exercise and early mobilization interventions are safe and improve physical and cognitive impairments, but there are critical barriers to their widespread implementation in acute care and home settings, including mobility limitations, reduced cardiopulmonary reserve, limited staff, and costs. Thus, there is an unmet need to develop interventions that can be utilized in both the inpatient and home environments to improve functional recovery in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and community-acquired pneumonia (CAP). This study addresses this clinical need and these barriers and will provide important feasibility and acceptability data regarding the utility of neuromuscular electrical stimulation (NMES) administered to lower extremity musculature across inpatient and post-discharge settings to improve functional and cognitive recovery in older adults hospitalized for AECOPD/CAP. Initial NMES sessions will begin during participants' stay at UVM Medical Center and will continue at home after hospital discharge. Study participants will be issued a portable NMES device to take home and instructed on its use. They will receive guidance and oversight on the use of the NMES device and will be asked to perform NMES treatments 6 days per week for 60 minutes per day for 6 weeks. Data will be collected via activity monitor, participant questionnaires and clinical assessments including strength testing and 6-minute-walk-test.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is neuromuscular electrical stimulation (NMES) safe for humans?

Research on NMES in cancer patients shows it is generally safe, with no reported adverse events in studies. It has been used safely to improve muscle strength and exercise capacity in these patients. ^{1 2 3 4 5}

How is the treatment NMES different from other treatments for COPD and pneumonia?

NMES (Neuromuscular Electrical Stimulation) is unique because it uses electrical impulses to stimulate muscles, improving muscle strength and endurance without the need for physical exercise, which is beneficial for patients with severe COPD who may struggle with traditional exercise due to breathing difficulties. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment NMES for COPD and Pneumonia?

Research shows that NMES can improve muscle strength and exercise capacity in people with severe COPD, making it a promising treatment option for those with limited ability to exercise due to breathing difficulties. ^{6 8 9 10 11}

Who Is on the Research Team?

Renee Stapleton, MD, PhD

Principal Investigator

University of Vermont Department of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 50 hospitalized with COPD or pneumonia, expected to stay at least two more days. They must be able to use NMES on both legs and not have severe skin issues, a BMI over 40, life expectancy under six months, certain heart devices, or be in ICU care. Participants should've been walking independently before admission.

Inclusion Criteria

I will be in the hospital for more than 2 days after joining.

I am in the hospital for pneumonia or a severe COPD flare-up.

I am over 50 years old.

Exclusion Criteria

You are expected to live for less than 6 months.

I have a condition that affects my ability to walk.

You are currently in jail.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive neuromuscular electrical stimulation (NMES) during hospitalization and continue at home for 6 weeks

6 weeks

Daily sessions (6 days per week)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of physical functioning and adherence

6 weeks

Assessments at enrollment, discharge, and 6-week follow-up

What Are the Treatments Tested in This Trial?

Interventions

• NMES

Trial Overview The study tests if neuromuscular electrical stimulation (NMES) can help older adults recover better from COPD/pneumonia. It starts in the hospital and continues at home for six weeks. Patients will use an NMES device on their legs daily and their recovery progress will be monitored through various assessments.

How Is the Trial Designed?

Group I: Pilot Study Cohort Experimental Treatment 1 Intervention

Every participant in this small prospective cohort study will receive the study intervention.

NMES is already approved in United States, European Union for the following indications:

Approved in United States as Neuromuscular Electrical Stimulation for:

• Muscle wasting and weakness after subarachnoid hemorrhage (SAH)
• Rehabilitation post-SAH

Approved in European Union as Neuromuscular Electrical Stimulation for:

• Muscle weakness and wasting in critically ill patients
• Rehabilitation post-SAH

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

Published Research Related to This Trial

Neuromuscular Electrostimulation (NMES) may help adults with COPD who are on mechanical ventilation (MV) by allowing them to move from bed to chair independently about 5 days faster and reducing their time on MV by nearly 3 days, based on a review of 4 randomized controlled trials with 144 participants.

While NMES shows promise in improving functional independence and reducing MV duration, its impact on muscle strength remains unclear, indicating a need for further research to confirm its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of neuromuscular electrostimulation in COPD subjects on mechanical ventilation. A systematic review and meta-analysis. Gutiérrez-Arias, R., Jalil, Y., Fuentes-Aspe, R., et al.[2022]

Neuromuscular electrical stimulation (NMES) is a feasible and well-tolerated intervention that can improve muscle strength in patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease (COPD), with significant strength gains observed in the 35 Hz frequency group.

Both high-frequency (50 Hz) and low-frequency (35 Hz) NMES resulted in increased muscle strength and endurance walking time, indicating that the effectiveness of NMES in this context is not dependent on the frequency used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular stimulation of quadriceps in patients hospitalised during an exacerbation of COPD: a comparison of low (35 Hz) and high (50 Hz) frequencies. Chaplin, EJ., Houchen, L., Greening, NJ., et al.[2022]

Neuromuscular electrical stimulation (NMES) is emerging as a promising rehabilitative approach for patients with advanced chronic obstructive pulmonary disease (COPD), offering an alternative to traditional exercise training.

NMES has a limited impact on ventilatory requirements and dyspnea, which may make it a safer option for patients who struggle with conventional physical reconditioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation of the lower limbs in patients with chronic obstructive pulmonary disease. Vivodtzev, I., Lacasse, Y., Maltais, F.[2022]

In a randomized controlled trial involving 22 patients with severe COPD, neuromuscular electrical stimulation (NMES) significantly improved quadriceps strength by 14% and endurance by 42% compared to a control group.

Despite the improvements in muscle function, NMES did not enhance walking endurance, indicating that while it can strengthen muscles, it may not directly translate to better walking performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation appears to be useful in people with severe chronic obstructive pulmonary disease. Gerovasili, V.[2012]

In a study involving 20 patients with advanced COPD, neuromuscular electrical stimulation (NMES) significantly improved muscle cross-sectional area, strength, and endurance compared to sham training, indicating its efficacy in enhancing muscle function.

The improvements in walking distance after NMES were linked to increased muscle strength and a better balance between muscle growth and breakdown, suggesting that NMES positively affects muscle metabolism in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Vivodtzev, I., Debigaré, R., Gagnon, P., et al.[2022]

In a study involving 49 patients with advanced non-small cell lung cancer (NSCLC), neuromuscular electrical stimulation (NMES) was found to be unacceptable, as only 50% of participants met the minimum adherence level of three sessions per week during palliative chemotherapy.

There were no serious adverse events related to NMES, and the intervention did not show significant benefits in improving muscle strength, thigh lean mass, or physical activity levels compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer receiving palliative chemotherapy: a randomized phase II study. Maddocks, M., Halliday, V., Chauhan, A., et al.[2022]

Neuromuscular electrical stimulation (NMES) is safe for use in adult cancer survivors and shows potential for improving health-related quality of life (HR-QoL), with a significant effect size of 0.36 in meta-analyses of nine studies.

While NMES may improve muscle strength, the evidence is not statistically significant, indicating that more high-quality research is needed to establish standardized treatment protocols and confirm its efficacy in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and prescription of neuromuscular electrical stimulation (NMES) in adult cancer survivors: a systematic review and meta-analysis. O'Connor, D., Caulfield, B., Lennon, O.[2023]

A pilot study involving 16 lung cancer patients showed that neuromuscular electrical stimulation (NMES) of the quadriceps muscles is feasible and well-accepted, with an adherence rate of 80%.

While NMES showed positive trends in improving quadriceps strength, physical activity, and exercise endurance, these changes were not statistically significant, indicating that further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot study of neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer. Maddocks, M., Lewis, M., Chauhan, A., et al.[2022]

In a study involving 14 cancer patients undergoing treatment, a 4-week NMES (neuromuscular electrical stimulation) exercise intervention significantly improved functional muscle strength and exercise capacity, with participants able to perform more sit-to-stand repetitions and walk further in 6 minutes.

No adverse events were reported during the intervention, suggesting that NMES exercise is a safe and effective option for enhancing physical function in cancer patients with moderate to poor functional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional, physiological and subjective responses to concurrent neuromuscular electrical stimulation (NMES) exercise in adult cancer survivors: a controlled prospective study. O'Connor, D., Lennon, O., Fernandez, MM., et al.[2021]

A personalized and progressive neuromuscular electrical stimulation (NMES) intervention over 4-8 weeks showed potential benefits in improving exercise capacity and quality of life for 6 out of 10 cancer patients, with significant improvements in functional strength and walking ability.

The intervention was reported to be safe, with patients expressing increased muscle strength and confidence in their mobility, suggesting NMES could be a valuable alternative to traditional exercise in cancer rehabilitation, pending further controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised and progressive neuromuscular electrical stimulation (NMES) in patients with cancer-a clinical case series. O'Connor, D., Fernandez, MM., Signorelli, G., et al.[2021]

Neuromuscular electrical stimulation (NMES) has been shown to significantly improve muscle strength and endurance in patients with severe chronic obstructive pulmonary disease (COPD), based on multiple randomized trials.

However, NMES does not appear to provide the same benefits for patients with moderate COPD, suggesting that its use should be specifically targeted to those with more advanced disease in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neuromuscular electrical stimulation improves the functional level in patients with severe chronic obstructive pulmonary disease]. Al-Gibouri, S., Ringbæk, T., Lange, P.[2019]

Citations

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

Effectiveness of neuromuscular electrostimulation in COPD subjects on mechanical ventilation. A systematic review and meta-analysis. [2022]

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

Neuromuscular stimulation of quadriceps in patients hospitalised during an exacerbation of COPD: a comparison of low (35 Hz) and high (50 Hz) frequencies. [2022]

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

Neuromuscular electrical stimulation of the lower limbs in patients with chronic obstructive pulmonary disease. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation appears to be useful in people with severe chronic obstructive pulmonary disease. [2012]

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

Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. [2022]

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

Neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer receiving palliative chemotherapy: a randomized phase II study. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

The efficacy and prescription of neuromuscular electrical stimulation (NMES) in adult cancer survivors: a systematic review and meta-analysis. [2023]

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

Randomized controlled pilot study of neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Functional, physiological and subjective responses to concurrent neuromuscular electrical stimulation (NMES) exercise in adult cancer survivors: a controlled prospective study. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Personalised and progressive neuromuscular electrical stimulation (NMES) in patients with cancer-a clinical case series. [2021]

11. Denmark pubmed.ncbi.nlm.nih.gov

[Neuromuscular electrical stimulation improves the functional level in patients with severe chronic obstructive pulmonary disease]. [2019]