Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia

NCT05452226 | Recruiting FDA Device

• 1 other identifier: STUDY00002023
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Community-acquired Pneumonia; COPD Exacerbation Acute

Outcome Measures

Primary Outcomes (4)

• Feasibility assessed by study recruitment

  recruitment of n=8 patients

  6 weeks

• Feasibility assessed by outcome assessment completion

  completion of ≥90% of secondary outcome assessments

  6 weeks

• Feasibility assessed by adherence to the intervention

  adherence to NMES of ≥80% during hospitalization and ≥60% at home

  6 weeks

• Acceptability as assessed by a NMES-specific questionnaire

  Acceptability of the NMES intervention will be measured using a 10-item questionnaire that uses a Likert rating scale developed by our group for use with NMES, with 5 items allowing further qualitative input from volunteers to identify action items for improving delivery of the NMES intervention.

  6 weeks

Secondary Outcomes (3)

• physical functioning: ability to walk independently

  enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up

• physical functioning: mobility of the lower extremity

  enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up

• knee extensor torque

  enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up

Study Arms (1)

Pilot Study Cohort

EXPERIMENTAL

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

Device: neuromuscular electrical stimulation (NMES)

Interventions

neuromuscular electrical stimulation (NMES) DEVICE

Electrical stimulation will be applied using two adhesive pads affixed to the front of both of the thighs. The intensity will be progressively increased to a level that provokes a strong contraction. The stimulation intensity will be increased until the stimulation is uncomfortable, but does not hurt. Care will be taken to make sure that the level of stimulation will be adjusted such that the intensity does not cause pain. Contractions will last 10 seconds, with 30 seconds of rest between. NMES will occur 6 days per week for 60 minutes per day. Patients will self-administer NMES 6 days per week after discharge for up to 6 weeks.

Pilot Study Cohort

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Renee Stapleton, MD, PhD

  University of Vermont Department of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Ardren, PA

CONTACT

(802) 656-7953; sara.ardren@med.uvm.edu

Stephanie Burns

CONTACT

(802) 656-2130; stephanie.burns@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: small, prospective cohort study where every participant receives the study intervention

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: July 11, 2022
• Study Start: July 12, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)