Abdominal Binding in 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?|
- 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 ] [ Designated as safety issue: No ]
- Exercise Endurance Time (EET) [ Time Frame: Patients will be followed until all study visits are complete, an expected average of 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2014|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: COPD AB ON
Abdominal Binder "ON"
Device: Abdominal Binder
Abdominal Binding to increase end-expiratory gastric pressure by 5-8 centimetres of water at rest.
Other Name: McDavid Inc., 493R Universal Back Support
No Intervention: COPD AB OFF
Abdominal Binder "OFF" (control)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01852006
|Montreal Chest Institute; McGill University Health Center & McGill University|
|Montreal, Quebec, Canada, H2X 2P4|
|Principal Investigator:||Dennis Jensen, Ph.D.||McGill University|