Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia
Primary Purpose
Community-acquired Pneumonia, COPD Exacerbation Acute
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neuromuscular electrical stimulation (NMES)
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia
Eligibility Criteria
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
Sites / Locations
- University of VermontRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilot Study Cohort
Arm Description
Every participant in this small prospective cohort study will receive the study intervention.
Outcomes
Primary Outcome Measures
Feasibility assessed by study recruitment
recruitment of n=8 patients
Feasibility assessed by outcome assessment completion
completion of ≥90% of secondary outcome assessments
Feasibility assessed by adherence to the intervention
adherence to NMES of ≥80% during hospitalization and ≥60% at home
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.
Secondary Outcome Measures
physical functioning: ability to walk independently
6 minute walk test (6MWT)
physical functioning: mobility of the lower extremity
short physical performance battery (SPPB)
knee extensor torque
isometric dynamometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05452226
Brief Title
Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia
Official Title
Neuromuscular Electrical Stimulation (NMES) in Patients Hospitalized With Acute Exacerbation of COPD and/or Community Acquired Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, COPD Exacerbation Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
small, prospective cohort study where every participant receives the study intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilot Study Cohort
Arm Type
Experimental
Arm Description
Every participant in this small prospective cohort study will receive the study intervention.
Intervention Type
Device
Intervention Name(s)
neuromuscular electrical stimulation (NMES)
Intervention Description
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 Outcome Measure Information:
Title
Feasibility assessed by study recruitment
Description
recruitment of n=8 patients
Time Frame
6 weeks
Title
Feasibility assessed by outcome assessment completion
Description
completion of ≥90% of secondary outcome assessments
Time Frame
6 weeks
Title
Feasibility assessed by adherence to the intervention
Description
adherence to NMES of ≥80% during hospitalization and ≥60% at home
Time Frame
6 weeks
Title
Acceptability as assessed by a NMES-specific questionnaire
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
physical functioning: ability to walk independently
Description
6 minute walk test (6MWT)
Time Frame
enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Title
physical functioning: mobility of the lower extremity
Description
short physical performance battery (SPPB)
Time Frame
enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Title
knee extensor torque
Description
isometric dynamometry
Time Frame
enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Ardren, PA
Phone
(802) 656-7953
Email
sara.ardren@med.uvm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Burns
Phone
(802) 656-2130
Email
stephanie.burns@uvmhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renee Stapleton, MD, PhD
Organizational Affiliation
University of Vermont Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Ardren, PA
Phone
802-656-7953
Email
sara.ardren@med.uvm.edu
First Name & Middle Initial & Last Name & Degree
Renee Stapleton, MD, PhD
First Name & Middle Initial & Last Name & Degree
Michael Toth, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia
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