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Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia

RECRUITINGN/ASponsored by University of Vermont
Actively Recruiting
PhaseN/A
SponsorUniversity of Vermont
Started2022-07-12
Est. completion2025-12-01
Eligibility
Age50 Years+
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 50 Years+Healthy volunteers accepted
Inclusion Criteria:

1. \>50 years old
2. Hospitalized for CAP and/or AECOPD
3. Expected hospital stay \>2 days after enrollment (to permit adequate application of and training in NMES)

Exclusion Criteria:

1. \>7 days of hospitalization prior to enrollment
2. Life expectancy \< 6 months
3. Clinical Frailty Scale87 score \>6
4. Lower extremity impairments that prevent bilateral use of NMES (e.g., amputation, leg injury)
5. Acute lower extremity deep vein thrombosis
6. Implanted cardioverter-defibrillator or pacemaker
7. Body mass index (BMI) \>40 kg/m2
8. Currently requiring ICU care (including for sepsis)90. Prior ICU care during this hospitalization acceptable.
9. Severe skin breakdown on either lower extremity
10. Not ambulating independently prior to admission (gait aid is permitted)
11. New or existing intracranial, spinal, vascular, or neuromuscular condition limiting walking ability
12. Language barrier prohibiting outcome assessment
13. More than mild pre-existing dementia (IQCODE\* score \>3.6)
14. Likely discharge to setting where study team cannot oversee/monitor intervention (e.g., skilled nursing facility where team cannot monitor compliance)
15. Incarcerated
16. Refuses informed consent

Conditions3

COPDCOPD Exacerbation AcuteCommunity-acquired Pneumonia

Locations1 site

University of Vermont
Burlington, Vermont, 05405
Sara Ardren, PA802-656-7953sara.ardren@med.uvm.edu

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