Pulmonary Disease, Chronic ObstructiveNCT02035228
Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients
A study testing Abdominal Stimulation - low / early, Abdominal stimulation - low/late and Abdominal Stimulation - low/full in people with Pulmonary Disease, Chronic Obstructive, run by Liberate Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Abdominal Stimulation - low / early, Abdominal stimulation - low/late and Abdominal Stimulation - low/full
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease: A Feasibility Study
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
- Being tested
- Abdominal Stimulation - low / early, Abdominal stimulation - low/late, Abdominal Stimulation - low/full, Abdominal stimulation - med/early, Abdominal stimulation - med/late
- Keywords
- Chronic Obstructive Pulmonary Disease, Lung Hyperinflation, Abdominal Muscle, Functional Electrical Stimulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Stimulation - low / earlyDevice
Also called SecondBreath
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
Abdominal stimulation - low/lateDevice
Also called SecondBreath
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
Abdominal Stimulation - low/fullDevice
Also called SecondBreath
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at low stimulation current throughout exhalation
Abdominal stimulation - med/earlyDevice
Also called SecondBreath
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
Abdominal stimulation - med/lateDevice
Also called SecondBreath
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
Abdominal Stimulation - med/fullDevice
Also called SecondBreath
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at medium stimulation current throughout exhalation
Abdominal Stimulation - high/earlyDevice
Also called SecondBreath
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
Abdominal Stimulation - high/lateDevice
Also called SecondBreath
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
Abdominal Stimulation - high/fullDevice
Also called SecondBreath
Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
Stimulation is applied at high stimulation current throughout exhalation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Abdominal Stimulation - high/full |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes
Change in inspiratory capacity during a 6 minute step test
Measured: 6 minutes
Secondary outcomes (5)
Average tidal volume during 2 minutes of resting breathing while seated
Measured: 2 minutes
Average minute ventilation during 2 minutes of resting breathing while seated
Measured: 2 minutes
Average peak expiratory flow rate during 2 minutes of resting breathing while seated
Measured: 2 minutes
Average breathing rate during two minutes of resting breathing while seated
Measured: 2 minutes
Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodney Folz, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035228
- Sponsor's protocol ID
- LM-SB-001
- Status last verified
- Aug 2018
- First submitted
- 10 Jan 2014
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02035228
- Acronym / sponsor ID
- LM-SB-001
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, Lung Hyperinflation, Abdominal Muscle, Functional Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Liberate MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seated | Experimental | 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/fullPatients 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 |
| 6 minute step test | Experimental | Device: Abdominal Stimulation - high/fullPatients will complete a 6 minute step test with and without abdominal stimulation (SecondBreath). Abdominal Stimulation - high/full |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Stimulation - low / earlyAlso: SecondBreathTranscutaneous 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 | Device | Seated |
| Abdominal stimulation - low/lateAlso: SecondBreathTranscutaneous 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 | Device | Seated |
| Abdominal Stimulation - low/fullAlso: SecondBreathTranscutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at low stimulation current throughout exhalation | Device | Seated |
| Abdominal stimulation - med/earlyAlso: SecondBreathTranscutaneous 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 | Device | Seated |
| Abdominal stimulation - med/lateAlso: SecondBreathTranscutaneous 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 | Device | Seated |
| Abdominal Stimulation - med/fullAlso: SecondBreathTranscutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at medium stimulation current throughout exhalation | Device | Seated |
| Abdominal Stimulation - high/earlyAlso: SecondBreathTranscutaneous 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 | Device | Seated |
| Abdominal Stimulation - high/lateAlso: SecondBreathTranscutaneous 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 | Device | Seated |
| Abdominal Stimulation - high/fullAlso: SecondBreathTranscutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at high stimulation current throughout exhalation | Device | 6 minute step test, Seated |
Primary outcome
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
5 secondary outcomes
Average tidal volume during 2 minutes of resting breathing while seated
Time frame: 2 minutes
Average minute ventilation during 2 minutes of resting breathing while seated
Time frame: 2 minutes
Average peak expiratory flow rate during 2 minutes of resting breathing while seated
Time frame: 2 minutes
Average breathing rate during two minutes of resting breathing while seated
Time frame: 2 minutes
Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test
Time frame: 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
Related trials for Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney Folz, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Stimulation - low / early, Abdominal stimulation - low/late and Abdominal Stimulation - low/full in people with Pulmonary Disease, Chronic Obstructive, run by Liberate Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inspiratory capacity during 2 minutes of resting breathing when patients were seated (time frame: 2 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.