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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seated | Experimental | 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 |
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| 6 minute step test | Experimental | Patients will complete a 6 minute step test with and without abdominal stimulation (SecondBreath). Abdominal Stimulation - high/full |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal Stimulation - low / early | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 minutes |
| Change in inspiratory capacity during a 6 minute step test | 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Average tidal volume during 2 minutes of resting breathing while seated | 2 minutes | |
| Average minute ventilation during 2 minutes of resting breathing while seated | 2 minutes | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodney Folz, PhD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States |
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| Abdominal stimulation - low/late | Device | 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 |
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| Abdominal Stimulation - low/full | Device | Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at low stimulation current throughout exhalation |
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| Abdominal stimulation - med/early | Device | 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 |
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| Abdominal stimulation - med/late | Device | 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 |
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| Abdominal Stimulation - med/full | Device | Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at medium stimulation current throughout exhalation |
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| Abdominal Stimulation - high/early | Device | 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 |
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| Abdominal Stimulation - high/late | Device | 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 |
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| Abdominal Stimulation - high/full | Device | Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at high stimulation current throughout exhalation |
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| Average peak expiratory flow rate during 2 minutes of resting breathing while seated |
| 2 minutes |
| Average breathing rate during two minutes of resting breathing while seated | 2 minutes |
| Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test | 6 minutes |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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