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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT02035228
• Lead Sponsor: Liberate Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in inspiratory capacity during 2 minutes of resting breathing when patients were seated	2 minutes	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.
Change in inspiratory capacity during a 6 minute step test	6 minutes

Secondary Outcome Measures

Name	Time	Method
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
Average peak expiratory flow rate during 2 minutes of resting breathing while seated	2 minutes
Average minute ventilation during 2 minutes of resting breathing while seated	2 minutes
Average tidal volume during 2 minutes of resting breathing while seated	2 minutes

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States