Abdominal Binding in Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?

Conditions
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Chronic Obstructive Pulmonary Disease, Dyspnea

Intervention / Treatment
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* Device: Abdominal Binder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD AB ON<br>Abdominal Binder ON | Device: Abdominal Binder<br>* Abdominal Binding to increase end-expiratory gastric pressure by 5-8 centimetres of water at rest.<br>* Other names: McDavid Inc., 493R Universal Back Support;|
| No Intervention: COPD AB OFF<br>Abdominal Binder OFF (control) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise |  | Patients will be followed until all study visits are complete, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Endurance Time (EET) |  | Patients will be followed until all study visits are complete, an expected average of 2 weeks |