8 Participants Needed

NMES for COPD and Pneumonia

SA
SB
Overseen ByStephanie Burns
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Vermont
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

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.678910

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.123411

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.

Research Team

RS

Renee Stapleton, MD, PhD

Principal Investigator

University of Vermont Department of Medicine

Eligibility Criteria

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.
See 13 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pilot Study CohortExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials
283
Recruited
3,747,000+

Findings from Research

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

References

Effectiveness of neuromuscular electrostimulation in COPD subjects on mechanical ventilation. A systematic review and meta-analysis. [2022]
Neuromuscular stimulation of quadriceps in patients hospitalised during an exacerbation of COPD: a comparison of low (35 Hz) and high (50 Hz) frequencies. [2022]
Neuromuscular electrical stimulation of the lower limbs in patients with chronic obstructive pulmonary disease. [2022]
Neuromuscular electrical stimulation appears to be useful in people with severe chronic obstructive pulmonary disease. [2012]
Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. [2022]
Neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer receiving palliative chemotherapy: a randomized phase II study. [2022]
The efficacy and prescription of neuromuscular electrical stimulation (NMES) in adult cancer survivors: a systematic review and meta-analysis. [2023]
Randomized controlled pilot study of neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer. [2022]
Functional, physiological and subjective responses to concurrent neuromuscular electrical stimulation (NMES) exercise in adult cancer survivors: a controlled prospective study. [2021]
Personalised and progressive neuromuscular electrical stimulation (NMES) in patients with cancer-a clinical case series. [2021]
[Neuromuscular electrical stimulation improves the functional level in patients with severe chronic obstructive pulmonary disease]. [2019]
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