Ignite Creation Date:
2024-05-06 @ 5:51 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05452226
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2022-06-14
Brief Title:
Neuromuscular Electrical Stimulation in COPDCommunity Acquired Pneumonia
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Neuromuscular Electrical Stimulation NMES in Patients Hospitalized With Acute Exacerbation of COPD andor Community Acquired Pneumonia
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AECOPDCAP
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
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 AECOPDCAP
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 25 million hospitalizations and 80 billion in costs annually22-28 Even before the COVID global pandemic disability after hospitalization for AECOPDCAP 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 interventions1330
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 AECOPDCAP
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 AECOPDCAP
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 25 million hospitalizations and 80 billion in costs annually22-28 Even before the COVID global pandemic disability after hospitalization for AECOPDCAP 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 interventions1330
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 AECOPDCAP
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 AECOPDCAP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None