Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients
NCT ID: NCT02035228
Last Updated: 2018-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2013-03-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Seated
Patients breathing will be compared across a series of 9 trials in which unassisted breathing is compared to abdominal stimulation (SecondBreath) assisted breathing at various intensities. Each breathing trial will last for 2 minutes and will be conducted while the patient is seated. The following abdominal stimulation trials were included:
Abdominal Stimulation - low / early Abdominal stimulation - low/late Abdominal Stimulation - low/full Abdominal stimulation - med/early Abdominal stimulation - med/late Abdominal Stimulation - med/full Abdominal Stimulation - high/early Abdominal Stimulation - high/late Abdominal Stimulation - high/full
Abdominal Stimulation - low / early
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at low stimulation current for the first half of exhalation
Abdominal stimulation - low/late
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at low stimulation current for the second half of exhalation
Abdominal Stimulation - low/full
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at low stimulation current throughout exhalation
Abdominal stimulation - med/early
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at medium stimulation current for the first half of exhalation
Abdominal stimulation - med/late
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at medium stimulation current for the second half of exhalation
Abdominal Stimulation - med/full
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at medium stimulation current throughout exhalation
Abdominal Stimulation - high/early
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at high stimulation current for the first half of exhalation
Abdominal Stimulation - high/late
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at hig stimulation current for the second half of exhalation
Abdominal Stimulation - high/full
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at high stimulation current throughout exhalation
6 minute step test
Patients will complete a 6 minute step test with and without abdominal stimulation (SecondBreath).
Abdominal Stimulation - high/full
Abdominal Stimulation - high/full
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at high stimulation current throughout exhalation
Interventions
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Abdominal Stimulation - low / early
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at low stimulation current for the first half of exhalation
Abdominal stimulation - low/late
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at low stimulation current for the second half of exhalation
Abdominal Stimulation - low/full
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at low stimulation current throughout exhalation
Abdominal stimulation - med/early
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at medium stimulation current for the first half of exhalation
Abdominal stimulation - med/late
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at medium stimulation current for the second half of exhalation
Abdominal Stimulation - med/full
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at medium stimulation current throughout exhalation
Abdominal Stimulation - high/early
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at high stimulation current for the first half of exhalation
Abdominal Stimulation - high/late
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at hig stimulation current for the second half of exhalation
Abdominal Stimulation - high/full
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at high stimulation current throughout exhalation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current or former smokers with at least a 20 pack year smoking history
* Over the age of forty
Exclusion Criteria
* Subjects unable to give informed consent
* Subjects unable to perform required activities of the study (e.g. Six minute walk test)
* Subjects with an implanted electronic device (e.g. a cardiac pacemaker)
* Subjects who have had a chronic obstructive pulmonary disease exacerbation within 30 days prior to enrollment
* Considerable arthritic changes that limit exertion
* Patients on oral prednisone
* Patients with a hernia
* Patients with a history of pneumothorax within the last 5 years
* History of epilepsy
* History of Abnormal electrocardiogram suggestive of cardiac disease
40 Years
ALL
No
Sponsors
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Liberate Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Rodney Folz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville
Louisville, Kentucky, United States
Countries
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Other Identifiers
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LM-SB-001
Identifier Type: -
Identifier Source: org_study_id
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