Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease: A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Liberate Medical
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change in inspiratory capacity during 2 minutes of resting breathing when patients were seated
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in inspiratory capacity during 2 minutes of resting breathing when patients were seated
Time Frame: 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
Time Frame: 6 minutes
Secondary Outcomes
- Average tidal volume 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)
- 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)