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

N/ACompletedNCT02035228

Liberate Medical7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Abdominal Stimulation - low / earlyDEVICE

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/lateDEVICE

Abdominal Stimulation - low/fullDEVICE

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at low stimulation current throughout exhalation

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Louisville

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 minutes

Change in inspiratory capacity during a 6 minute step test

Time frame: 6 minutes

Secondary Outcomes

Average tidal volume during 2 minutes of resting breathing while seated

Time frame: 2 minutes

Average minute ventilation during 2 minutes of resting breathing while seated

Time frame: 2 minutes

Average peak expiratory flow rate during 2 minutes of resting breathing while seated

Time frame: 2 minutes

Average breathing rate during two minutes of resting breathing while seated

Time frame: 2 minutes

Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test

Time frame: 6 minutes

Data from ClinicalTrials.gov

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