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

NCT02035228 | Completed FDA Device

• 1 other identifier: LM-SB-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; Lung Hyperinflation; Abdominal Muscle; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• 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

• Change in inspiratory capacity during a 6 minute step test

  6 minutes

Secondary Outcomes (5)

• Average tidal volume during 2 minutes of resting breathing while seated

  2 minutes

• Average minute ventilation during 2 minutes of resting breathing while seated

  2 minutes

• Average peak expiratory flow rate 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

Study Arms (2)

Seated

EXPERIMENTAL

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; 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

6 minute step test

EXPERIMENTAL

Patients will complete a 6 minute step test with and without abdominal stimulation (SecondBreath). Abdominal Stimulation - high/full

Device: Abdominal Stimulation - high/full

Interventions

Abdominal Stimulation - low / early DEVICE

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

Also known as: SecondBreath

Seated

Abdominal stimulation - low/late DEVICE

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

Also known as: SecondBreath

Seated

Abdominal Stimulation - low/full DEVICE

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at low stimulation current throughout exhalation

Also known as: SecondBreath

Seated

Abdominal stimulation - med/early DEVICE

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

Also known as: SecondBreath

Seated

Abdominal stimulation - med/late DEVICE

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

Also known as: SecondBreath

Seated

Abdominal Stimulation - med/full DEVICE

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at medium stimulation current throughout exhalation

Also known as: SecondBreath

Seated

Abdominal Stimulation - high/early DEVICE

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

Also known as: SecondBreath

Seated

Abdominal Stimulation - high/late DEVICE

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

Also known as: SecondBreath

Seated

Abdominal Stimulation - high/full DEVICE

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at high stimulation current throughout exhalation

Also known as: SecondBreath

6 minute step test; Seated

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liberate Medical: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodney Folz, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)