Back to resultsAbdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional device feasibility trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease, Lung Hyperinflation, Abdominal Muscle, Functional Electrical Stimulation
Eligibility Criteria
Inclusion Criteria:
- Post-bronchodilator FEV1/FVC ratio of less than 0.7 and post-bronchodilator FEV1 between 30 and 80 % predicted.
- Current or former smokers with at least a 20 pack year smoking history
- Over the age of forty
Exclusion Criteria:
- Female subjects who are pregnant
- 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
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Seated
6 minute step test
Arm Description
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
Patients will complete a 6 minute step test with and without abdominal stimulation (SecondBreath). Abdominal Stimulation - high/full
Outcomes
Primary Outcome Measures
Change in inspiratory capacity during 2 minutes of resting breathing when patients were seated
Inspiratory Capacity was measured before and after two minute periods of volitional and abdominal stimulation assisted breathing. The two minute trials of breathing were measured while patients were seated.
Change in inspiratory capacity during a 6 minute step test
Secondary Outcome Measures
Average tidal volume during 2 minutes of resting breathing while seated
Average minute ventilation during 2 minutes of resting breathing while seated
Average peak expiratory flow rate during 2 minutes of resting breathing while seated
Average breathing rate during two minutes of resting breathing while seated
Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02035228
Brief Title
Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients
Official Title
Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liberate Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an early feasibility study to investigate whether transcutaneous electrical stimulation applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to support ventilation and affect hyperinflation in patients with chronic obstructive pulmonary disease. As part of this study, the effect of a range of stimulation intensities and stimulation timing profiles will be explored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Chronic Obstructive Pulmonary Disease, Lung Hyperinflation, Abdominal Muscle, Functional Electrical Stimulation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seated
Arm Type
Experimental
Arm Description
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
Arm Title
6 minute step test
Arm Type
Experimental
Arm Description
Patients will complete a 6 minute step test with and without abdominal stimulation (SecondBreath).
Abdominal Stimulation - high/full
Intervention Type
Device
Intervention Name(s)
Abdominal Stimulation - low / early
Other Intervention Name(s)
SecondBreath
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Abdominal stimulation - low/late
Other Intervention Name(s)
SecondBreath
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Abdominal Stimulation - low/full
Other Intervention Name(s)
SecondBreath
Intervention Description
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at low stimulation current throughout exhalation
Intervention Type
Device
Intervention Name(s)
Abdominal stimulation - med/early
Other Intervention Name(s)
SecondBreath
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Abdominal stimulation - med/late
Other Intervention Name(s)
SecondBreath
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Abdominal Stimulation - med/full
Other Intervention Name(s)
SecondBreath
Intervention Description
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at medium stimulation current throughout exhalation
Intervention Type
Device
Intervention Name(s)
Abdominal Stimulation - high/early
Other Intervention Name(s)
SecondBreath
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Abdominal Stimulation - high/late
Other Intervention Name(s)
SecondBreath
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Abdominal Stimulation - high/full
Other Intervention Name(s)
SecondBreath
Intervention Description
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at high stimulation current throughout exhalation
Primary Outcome Measure Information:
Title
Change in inspiratory capacity during 2 minutes of resting breathing when patients were seated
Description
Inspiratory Capacity was measured before and after two minute periods of volitional and abdominal stimulation assisted breathing. The two minute trials of breathing were measured while patients were seated.
Time Frame
2 minutes
Title
Change in inspiratory capacity during a 6 minute step test
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Average tidal volume during 2 minutes of resting breathing while seated
Time Frame
2 minutes
Title
Average minute ventilation during 2 minutes of resting breathing while seated
Time Frame
2 minutes
Title
Average peak expiratory flow rate during 2 minutes of resting breathing while seated
Time Frame
2 minutes
Title
Average breathing rate during two minutes of resting breathing while seated
Time Frame
2 minutes
Title
Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-bronchodilator FEV1/FVC ratio of less than 0.7 and post-bronchodilator FEV1 between 30 and 80 % predicted.
Current or former smokers with at least a 20 pack year smoking history
Over the age of forty
Exclusion Criteria:
Female subjects who are pregnant
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney Folz, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
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Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients
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