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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035228
• Other study ID #: LM-SB-001
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2018
• Source: Liberate Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Liberate Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in inspiratory capacity during a 6 minute step test		6 minutes
Secondary	Average tidal volume during 2 minutes of resting breathing while seated		2 minutes
Secondary	Average minute ventilation during 2 minutes of resting breathing while seated		2 minutes
Secondary	Average peak expiratory flow rate during 2 minutes of resting breathing while seated		2 minutes
Secondary	Average breathing rate during two minutes of resting breathing while seated		2 minutes
Secondary	Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test		6 minutes