Chronic Obstructive Pulmonary DiseaseNCT01852006
Abdominal Binding in Chronic Obstructive Pulmonary Disease
A study testing Abdominal Binder in people with Chronic Obstructive Pulmonary Disease and Dyspnea, run by McGill University at 1 site in Canada.
Trial summary
Conventional approaches to relieve dyspnea (respiratory discomfort) in chronic obstructive pulmonary disease (COPD) have focused on improving respiratory motor drive (e.g., hyperoxia) and/or dynamic respiratory mechanics (e.g., bronchodilators). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Dyspnea
- What is being tested?
- Abdominal Binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to May 2015
- 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
- Male or Female
- Aged ≥40 years
- Ambulatory
- Cigarette smoking history ≥15 pack years
- No change in medication dosage or frequency of administration, with no exacerbations or hospitalization in the preceding 6 weeks.
- Post-bronchodilator Forced Expiratory Volume in 1 second between 30-80% predicted
- Post-bronchodilator Forced Expiratory Volume in 1 second/forced vital capacity ratio of <70%
Who cannot join
- Presence of active cardiopulmonary disease other than COPD
- Use of domiciliary oxygen
- Exercise-induced arterial blood oxyhemoglobin desaturation to <80% on room air.
- Body Mass Index <18.5 or ≥35 kg/m2.
- Allergy to latex
- Allergy to lidocaine or its "caine" derivates.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal Chest Institute; McGill University Health Center & McGill University
Montreal, Quebec, H2X 2P4
About this study
Official title: Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?
Conventional approaches to relieve dyspnea (respiratory discomfort) in chronic obstructive pulmonary disease (COPD) have focused on improving respiratory motor drive (e.g., hyperoxia) and/or dynamic respiratory mechanics (e.g., bronchodilators). Although these approaches yield meaningful symptom improvements there remains many COPD patients incapacitated by dyspnea. Accumulating evidence suggests that abdominal binding (AB) is a potentially novel method of improving respiratory muscle function and, by extension, dyspnea and exercise tolerance in COPD. Thus, the purpose of this randomized, cross-over study is to test the hypothesis that AB improves exertional dyspnea and exercise tolerance in symptomatic patients with COPD by improving dynamic respiratory muscle function. To this end, the investigators will examine the effects of AB on detailed assessments of baseline pulmonary function (spirometry, plethysmography), dyspnea (sensory intensity \& affective responses), neural respiratory drive (diaphragm EMG), contractile respiratory muscle function (esophageal, gastric \& transdiaphragmatic pressures), ventilation, breathing pattern and cardiometabolic function during symptom-limited constant load cycle exercise (75% Wmax) in 20 patients with GOLD stage II/III COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease, Dyspnea
- Being tested
- Abdominal Binder
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal BinderDevice
Also called McDavid Inc., 493R Universal Back Support
Abdominal Binding to increase end-expiratory gastric pressure by 5-8 centimetres of water at rest.
| Study group | Role | What they receive |
|---|---|---|
| COPD AB ON | Experimental | Abdominal Binder "ON" Receives: Device: Abdominal Binder |
| COPD AB OFF | No intervention | Abdominal Binder "OFF" (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise
Measured: Patients will be followed until all study visits are complete, an expected average of 2 weeks
Secondary outcomes (1)
Exercise Endurance Time (EET)
Measured: Patients will be followed until all study visits are complete, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Jensen, Ph.D., McGill University
- Investigators
- Dennis Jensen, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852006
- Sponsor's protocol ID
- RI MUHC 3234
- Status last verified
- Aug 2015
- First submitted
- 7 May 2013
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdallah SJ, Smith BM, Wilkinson-Maitland C, Li PZ, Bourbeau J, Jensen D. Effect of Abdominal Binding on Diaphragmatic Neuromuscular Efficiency, Exertional Breathlessness, and Exercise Endurance in Chronic Obstructive Pulmonary Disease. Front Physiol. 2018 Nov 14;9:1618. doi: 10.3389/fphys.2018.01618. eCollection 2018.
PubMed 30487757
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?
- ClinicalTrials.gov ID
- NCT01852006
- Acronym / sponsor ID
- RI MUHC 3234
- Conditions
- Chronic Obstructive Pulmonary Disease, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 May 2013 (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.
Conventional approaches to relieve dyspnea (respiratory discomfort) in chronic obstructive pulmonary disease (COPD) have focused on improving respiratory motor drive (e.g., hyperoxia) and/or dynamic respiratory mechanics (e.g., bronchodilators). Although these approaches yield meaningful symptom improvements there remains many COPD patients incapacitated by dyspnea. Accumulating evidence suggests that abdominal binding (AB) is a potentially novel method of improving respiratory muscle function and, by extension, dyspnea and exercise tolerance in COPD. Thus, the purpose of this randomized, cross-over study is to test the hypothesis that AB improves exertional dyspnea and exercise tolerance in symptomatic patients with COPD by improving dynamic respiratory muscle function. To this end, the investigators will examine the effects of AB on detailed assessments of baseline pulmonary function (spirometry, plethysmography), dyspnea (sensory intensity \& affective responses), neural respiratory drive (diaphragm EMG), contractile respiratory muscle function (esophageal, gastric \& transdiaphragmatic pressures), ventilation, breathing pattern and cardiometabolic function during symptom-limited constant load cycle exercise (75% Wmax) in 20 patients with GOLD stage II/III COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD AB ON | Experimental | Device: Abdominal BinderAbdominal Binder "ON" |
| COPD AB OFF | No intervention | –Abdominal Binder "OFF" (control) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female
- Aged ≥40 years
- Ambulatory
- Cigarette smoking history ≥15 pack years
- No change in medication dosage or frequency of administration, with no exacerbations or hospitalization in the preceding 6 weeks.
Key exclusion criteria (6 listed)
- Presence of active cardiopulmonary disease other than COPD
- Use of domiciliary oxygen
- Exercise-induced arterial blood oxyhemoglobin desaturation to <80% on room air.
- Body Mass Index <18.5 or ≥35 kg/m2.
- Allergy to latex
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 BinderAlso: McDavid Inc., 493R Universal Back SupportAbdominal Binding to increase end-expiratory gastric pressure by 5-8 centimetres of water at rest. | Device | COPD AB ON |
Primary outcome
Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise
Time frame: Patients will be followed until all study visits are complete, an expected average of 2 weeks
1 secondary outcome
Exercise Endurance Time (EET)
Time frame: Patients will be followed until all study visits are complete, an expected average of 2 weeks
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 26 Aug 2015.
- Derived from this study: PubMed 30487757Abdallah SJ, Smith BM, Wilkinson-Maitland C, Li PZ, Bourbeau J, Jensen D. Effect of Abdominal Binding on Diaphragmatic Neuromuscular Efficiency, Exertional Breathlessness, and Exercise Endurance in Chronic Obstructive Pulmonary Disease. Front Physiol. 2018 Nov 14;9:1618. doi: 10.3389/fphys.2018.01618. eCollection 2018.
- Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill UniversityLink provided by the sponsor.
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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.
Dennis Jensen, Ph.D. principal investigator
McGill University
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 Binder in people with Chronic Obstructive Pulmonary Disease and Dyspnea, run by McGill University at 1 site in Canada.
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 7 inclusion and 6 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 26 Aug 2015. 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 Canada. 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?
Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise (time frame: Patients will be followed until all study visits are complete, an expected average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852006, which also lists 1 linked publication.
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 26 Aug 2015.