NMES for COPD and Pneumonia
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?
Is neuromuscular electrical stimulation (NMES) safe for humans?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neuromuscular electrical stimulation (NMES) during hospitalization and continue at home for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of physical functioning and adherence
Treatment Details
Interventions
- NMES
NMES is already approved in United States, European Union for the following indications:
- Muscle wasting and weakness after subarachnoid hemorrhage (SAH)
- Rehabilitation post-SAH
- 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