RECRUITING

Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-12
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05452226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. \>50 years old
  2. 2. Hospitalized for CAP and/or AECOPD
  3. 3. Expected hospital stay \>2 days after enrollment (to permit adequate application of and training in NMES)
  1. 1. \>7 days of hospitalization prior to enrollment
  2. 2. Life expectancy \< 6 months
  3. 3. Clinical Frailty Scale87 score \>6
  4. 4. Lower extremity impairments that prevent bilateral use of NMES (e.g., amputation, leg injury)
  5. 5. Acute lower extremity deep vein thrombosis
  6. 6. Implanted cardioverter-defibrillator or pacemaker
  7. 7. Body mass index (BMI) \>40 kg/m2
  8. 8. Currently requiring ICU care (including for sepsis)90. Prior ICU care during this hospitalization acceptable.
  9. 9. Severe skin breakdown on either lower extremity
  10. 10. Not ambulating independently prior to admission (gait aid is permitted)
  11. 11. New or existing intracranial, spinal, vascular, or neuromuscular condition limiting walking ability
  12. 12. Language barrier prohibiting outcome assessment
  13. 13. More than mild pre-existing dementia (IQCODE\* score \>3.6)
  14. 14. Likely discharge to setting where study team cannot oversee/monitor intervention (e.g., skilled nursing facility where team cannot monitor compliance)
  15. 15. Incarcerated
  16. 16. Refuses informed consent

Contacts and Locations

Study Contact

Sara Ardren, PA
CONTACT
(802) 656-7953
sara.ardren@med.uvm.edu
Stephanie Burns
CONTACT
(802) 656-2130
stephanie.burns@uvmhealth.org

Principal Investigator

Renee Stapleton, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Vermont Department of Medicine

Study Locations (Sites)

University of Vermont
Burlington, Vermont, 05405
United States

Collaborators and Investigators

Sponsor: University of Vermont

  • Renee Stapleton, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Vermont Department of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-12
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-07-12
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Community-acquired Pneumonia
  • COPD Exacerbation Acute