Community-acquired PneumoniaNCT05452226
Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia
A study testing neuromuscular electrical stimulation (NMES) in people with Community-acquired Pneumonia and COPD Exacerbation Acute, run by University of Vermont at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Community-acquired Pneumonia, COPD Exacerbation Acute
- What is being tested?
- neuromuscular electrical stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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)
Who cannot join
- >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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Electrical Stimulation (NMES) in Patients Hospitalized With Acute Exacerbation of COPD and/or 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.
Read the 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.
- Being tested
- neuromuscular electrical stimulation (NMES)
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Study Cohort | Experimental | Every participant in this small prospective cohort study will receive the study intervention. Receives: Device: neuromuscular electrical stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by study recruitment
recruitment of n=8 patients
Measured: 6 weeks
Feasibility assessed by outcome assessment completion
completion of ≥90% of secondary outcome assessments
Measured: 6 weeks
Feasibility assessed by adherence to the intervention
adherence to NMES of ≥80% during hospitalization and ≥60% at home
Measured: 6 weeks
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.
Measured: 6 weeks
Secondary outcomes (3)
physical functioning: ability to walk independently
6 minute walk test (6MWT)
Measured: enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
physical functioning: mobility of the lower extremity
short physical performance battery (SPPB)
Measured: enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
knee extensor torque
isometric dynamometry
Measured: enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start12 Jul 2022
- Primary completion1 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- small, prospective cohort study where every participant receives the study intervention
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renee Stapleton, University of Vermont
- Investigators
- Renee Stapleton, MD, PhD, Principal investigator, University of Vermont Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452226
- Sponsor's protocol ID
- STUDY00002023
- Status last verified
- Feb 2025
- First submitted
- 14 Jun 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation (NMES) in Patients Hospitalized With Acute Exacerbation of COPD and/or Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT05452226
- Acronym / sponsor ID
- STUDY00002023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- small, prospective cohort study where every participant receives the study intervention
| Arm | Type | Receives |
|---|---|---|
| Pilot Study Cohort | Experimental | Device: neuromuscular electrical stimulation (NMES)Every participant in this small prospective cohort study will receive the study intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >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)
Key exclusion criteria (16 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Pilot Study Cohort |
Primary outcome
Feasibility assessed by study recruitment
Time frame: 6 weeks
recruitment of n=8 patients
Feasibility assessed by outcome assessment completion
Time frame: 6 weeks
completion of ≥90% of secondary outcome assessments
Feasibility assessed by adherence to the intervention
Time frame: 6 weeks
adherence to NMES of ≥80% during hospitalization and ≥60% at home
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.
3 secondary outcomes
physical functioning: ability to walk independently
Time frame: enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
physical functioning: mobility of the lower extremity
Time frame: enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
knee extensor torque
Time frame: enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee Stapleton, MD, PhD principal investigator
University of Vermont Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulation (NMES) in people with Community-acquired Pneumonia and COPD Exacerbation Acute, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by study recruitment (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.