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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035228
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Liberate Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease: A Feasibility Study
Study Start Date : March 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: SecondBreath


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Change in inspiratory capacity during a 6 minute step test [ Time Frame: 6 minutes ]

Secondary Outcome Measures :
  1. Average tidal volume during 2 minutes of resting breathing while seated [ Time Frame: 2 minutes ]
  2. Average minute ventilation during 2 minutes of resting breathing while seated [ Time Frame: 2 minutes ]
  3. Average peak expiratory flow rate during 2 minutes of resting breathing while seated [ Time Frame: 2 minutes ]
  4. Average breathing rate during two minutes of resting breathing while seated [ Time Frame: 2 minutes ]
  5. Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test [ Time Frame: 6 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • History of Abnormal electrocardiogram suggestive of cardiac disease
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035228


Locations
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United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Liberate Medical
Investigators
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Principal Investigator: Rodney Folz, PhD University of Louisville
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Liberate Medical
ClinicalTrials.gov Identifier: NCT02035228    
Other Study ID Numbers: LM-SB-001
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Liberate Medical:
Chronic Obstructive Pulmonary Disease
Lung Hyperinflation
Abdominal Muscle
Functional Electrical Stimulation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases