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Behavioural Intervention
NMES for COPD and Pneumonia
N/A
Recruiting
Led By Renee Stapleton, MD, PhD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized for CAP and/or AECOPD
>50 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Awards & highlights
Study Summary
This trial will test the feasibility and acceptability of using electrical stimulation to improve physical and cognitive recovery in older adults hospitalized for AECOPD/CAP.
Who is the study for?
This trial is for adults over 50 hospitalized with COPD or pneumonia, expected to stay at least two more days. They must be able to use NMES on both legs and not have severe skin issues, a BMI over 40, life expectancy under six months, certain heart devices, or be in ICU care. Participants should've been walking independently before admission.Check my eligibility
What is being tested?
The study tests if neuromuscular electrical stimulation (NMES) can help older adults recover better from COPD/pneumonia. It starts in the hospital and continues at home for six weeks. Patients will use an NMES device on their legs daily and their recovery progress will be monitored through various assessments.See study design
What are the potential side effects?
Potential side effects of NMES may include discomfort or pain at the stimulation site, muscle fatigue after treatment, skin irritation beneath electrode pads, and rarely muscle twitching during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the hospital for pneumonia or a severe COPD flare-up.
Select...
I am over 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment, time of hospital discharge up to 6 weeks, 6 week follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability as assessed by a NMES-specific questionnaire
Feasibility assessed by adherence to the intervention
Feasibility assessed by outcome assessment completion
+1 moreSecondary outcome measures
knee extensor torque
physical functioning: ability to walk independently
physical functioning: mobility of the lower extremity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pilot Study CohortExperimental Treatment1 Intervention
Every participant in this small prospective cohort study will receive the study intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
neuromuscular electrical stimulation (NMES)
2007
Completed Phase 3
~90
Find a Location
Who is running the clinical trial?
University of VermontLead Sponsor
267 Previous Clinical Trials
3,743,733 Total Patients Enrolled
Renee Stapleton, MD, PhDPrincipal InvestigatorUniversity of Vermont Department of Medicine
2 Previous Clinical Trials
118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for less than 6 months.I have a condition that affects my ability to walk.You are currently in jail.You have a very high body mass index (BMI).I cannot use NMES on both legs due to an impairment like amputation or injury.I am currently in or have been in the ICU this hospital stay.I will be in the hospital for more than 2 days after joining.I am in the hospital for pneumonia or a severe COPD flare-up.I am over 50 years old.You are unable to communicate in the language needed to assess your progress in the study.You have a pacemaker or defibrillator implanted.I have severe skin damage on my leg.You have severe memory and thinking problems.I was not walking on my own before being admitted to the hospital, but I can use a walking aid.You have a Clinical Frailty Scale score higher than 6.I have a blood clot in the deep veins of my leg.
Research Study Groups:
This trial has the following groups:- Group 1: Pilot Study Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be given the chance to try this new medication?
"Yes, that is accurate. The listing on clinicaltrials.gov states that this trial is currently looking for participants. This study was originally posted on July 12th, 2022 and has had one edits since then, which occurred on October 31st, 2022. 8 patients are needed for this trial taking place at 1 location."
Answered by AI
Are people still being signed up for this experiment?
"Active recruitment suggests that this study is still looking for patients. The listing was first posted on July 12th, 2020 and updated as recently as October 31st, 2020."
Answered by AI
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