Abdominal Binding in Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease, Dyspnea
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Abdominal Binder
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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.
Sites / Locations
- Montreal Chest Institute; McGill University Health Center & McGill University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
COPD AB ON
COPD AB OFF
Arm Description
Abdominal Binder "ON"
Abdominal Binder "OFF" (control)
Outcomes
Primary Outcome Measures
Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise
Secondary Outcome Measures
Exercise Endurance Time (EET)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01852006
Brief Title
Abdominal Binding in Chronic Obstructive Pulmonary Disease
Official Title
Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Dyspnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD AB ON
Arm Type
Experimental
Arm Description
Abdominal Binder "ON"
Arm Title
COPD AB OFF
Arm Type
No Intervention
Arm Description
Abdominal Binder "OFF" (control)
Intervention Type
Device
Intervention Name(s)
Abdominal Binder
Other Intervention Name(s)
McDavid Inc., 493R Universal Back Support
Intervention Description
Abdominal Binding to increase end-expiratory gastric pressure by 5-8 centimetres of water at rest.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Exercise Endurance Time (EET)
Time Frame
Patients will be followed until all study visits are complete, an expected average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Chest Institute; McGill University Health Center & McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30487757
Citation
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.
Results Reference
derived
Links:
URL
http://www.mcgill.ca/cerpl
Description
Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University
Learn more about this trial
Abdominal Binding in Chronic Obstructive Pulmonary Disease
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