Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Lung Hyperinflation, Abdominal Muscle, Functional Electrical Stimulation
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.
Interventions
DEVICEAbdominal 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
DEVICEAbdominal 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
DEVICEAbdominal 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
DEVICEAbdominal 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
DEVICEAbdominal 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
DEVICEAbdominal 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
DEVICEAbdominal 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
DEVICEAbdominal 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
DEVICEAbdominal 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
Sponsors
Liberate Medical
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Average peak expiratory flow rate during 2 minutes of resting breathing while seated | 2 minutes |
| Average tidal volume during 2 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 breathing rate during two minutes of resting breathing while seated | 2 minutes |
| Average minute ventilation during 2 minutes of resting breathing while seated | 2 minutes |
Countries
United States
Outcome results
None listed