Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients

Study Overview
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Brief Summary
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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.

Official Title
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Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease: A Feasibility Study

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Abdominal Stimulation - low / early
* Device: Abdominal stimulation - low/late
* Device: Abdominal Stimulation - low/full
* Device: Abdominal stimulation - med/early
* Device: Abdominal stimulation - med/late
* Device: Abdominal Stimulation - med/full
* Device: Abdominal Stimulation - high/early
* Device: Abdominal Stimulation - high/late
* Device: Abdominal Stimulation - high/full


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seated<br>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 | Device: Abdominal Stimulation - low / early<br>* 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<br>* Other names: SecondBreath;Device: Abdominal stimulation - low/late<br>* 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<br>* Other names: SecondBreath;Device: Abdominal Stimulation - low/full<br>* Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at low stimulation current throughout exhalation<br>* Other names: SecondBreath;Device: Abdominal stimulation - med/early<br>* 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<br>* Other names: SecondBreath;Device: Abdominal stimulation - med/late<br>* 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<br>* Other names: SecondBreath;Device: Abdominal Stimulation - med/full<br>* Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at medium stimulation current throughout exhalation<br>* Other names: SecondBreath;Device: Abdominal Stimulation - high/early<br>* 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<br>* Other names: SecondBreath;Device: Abdominal Stimulation - high/late<br>* 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<br>* Other names: SecondBreath;Device: Abdominal Stimulation - high/full<br>* Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at high stimulation current throughout exhalation<br>* Other names: SecondBreath;|
| Experimental: 6 minute step test<br>Patients will complete a 6 minute step test with and without abdominal stimulation (SecondBreath). Abdominal Stimulation - high/full | Device: Abdominal Stimulation - high/full<br>* Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at high stimulation current throughout exhalation<br>* Other names: SecondBreath;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Lung Hyperinflation, Abdominal Muscle, Functional Electrical Stimulation