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

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

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 Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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; Other Names: SecondBreath; Device: 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; Other Names: SecondBreath; Device: 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; Other Names: SecondBreath; Device: 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; Other Names: SecondBreath; Device: 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; Other Names: SecondBreath; Device: 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; Other Names: SecondBreath; Device: 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; Other Names: SecondBreath; Device: 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; Other Names: SecondBreath; Device: 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 Names: SecondBreath
Experimental: 6 minute step test; Patients will complete a 6 minute step test with and without abdominal stimulation (SecondBreath). Abdominal Stimulation - high/full	Device: 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 Names: SecondBreath

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Liberate Medical
• Investigators: Principal Investigator: Rodney Folz, PhD, University of Louisville

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Functional Electrical Stimulation; Lung Hyperinflation; Abdominal Muscle
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: LM-SB-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No