Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia

Community-acquired Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452226
• Other study ID #: STUDY00002023
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Vermont
• Contact: Sara Ardren, PA
• Phone: (802) 656-7953
• Email: sara.ardren[@]med.uvm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• COPD Exacerbation Acute
• Pneumonia

Intervention

Device:
• neuromuscular electrical stimulation (NMES)
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.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility assessed by study recruitment	recruitment of n=8 patients	6 weeks
Primary	Feasibility assessed by outcome assessment completion	completion of =90% of secondary outcome assessments	6 weeks
Primary	Feasibility assessed by adherence to the intervention	adherence to NMES of =80% during hospitalization and =60% at home	6 weeks
Primary	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	physical functioning: ability to walk independently	6 minute walk test (6MWT)	enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Secondary	physical functioning: mobility of the lower extremity	short physical performance battery (SPPB)	enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Secondary	knee extensor torque	isometric dynamometry	enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up