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Completed

NCT Number: NCT05452226

Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05405, United States

About this study

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 death1-11. The syndrome of "long COVID" has drawn attention to the physical and psychological sequelae of hospitalization for acute respiratory illness (ARI), but this is not a new phenomenon. In patients with ARI, hospital-acquired functional impairments persist long after hospitalization, due to limited use to rehabilitative interventions in the inpatient or post-acute settings12-14. Exercise and early mobilization interventions are safe15 and improve physical and cognitive impairments16-19, 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, novel, interventions are needed that are portable, easy to use, and require minimal costs and equipment.

Community-acquired pneumonia (CAP) and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) are leading causes of hospitalization in older adults20. These diagnoses often overlap21, cause substantial morbidity and mortality, and together account for >2.5 million hospitalizations and >$80 billion in costs annually22-28. Even before the COVID global pandemic, disability after hospitalization for AECOPD/CAP was on the rise29, due, in part, to an inability to remediate hospital-acquired impairments secondary to the lack of availability and low utilization of rehabilitation interventions13,30.

Physical rehabilitation improves mobility and attenuates hospital-acquired disability16-18, but these services are limited and their utilization in the hospital and after discharge is low. For instance, rehabilitation programs are absent or grossly underutilized for most general medical conditions, such as CAP. Even among patients with COPD, where rehabilitation has well-proven benefits and is supported by third party payers, uptake of pulmonary rehabilitation (PR) after hospitalization is very poor, with <3% participation within 1 year13. Low utilization of these services is due, in part, to barriers to delivering rehabilitation interventions in patient populations in the acute and post-discharge care settings, including inadequate staffing, costs, disease symptoms, reduced cardiopulmonary reserve, and lack of facility-based programs. 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 AECOPD/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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >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)

Exclusion criteria

  • >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
  • Refuses informed consent

Treatment and study plan

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.

Primary outcomes

  1. Feasibility assessed by study recruitment

    Time frame: 6 weeks

    recruitment of n=8 patients

  2. Feasibility assessed by outcome assessment completion

    Time frame: 6 weeks

    completion of ≥90% of secondary outcome assessments

  3. Feasibility assessed by adherence to the intervention

    Time frame: 6 weeks

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

  4. Acceptability as assessed by a NMES-specific questionnaire

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. physical functioning: ability to walk independently

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

    6 minute walk test (6MWT)

  2. physical functioning: mobility of the lower extremity

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

    short physical performance battery (SPPB)

  3. knee extensor torque

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

    isometric dynamometry

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study title

Neuromuscular Electrical Stimulation (NMES) in Patients Hospitalized With Acute Exacerbation of COPD and/or Community Acquired Pneumonia

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2022
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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