Abdominal Binding in Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Dyspnea
• Interventions: Device: Abdominal Binder

• Registration Number: NCT01852006
• Lead Sponsor: McGill University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-13
• Study Start: 2014-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
COPD AB ON	Abdominal Binder	Abdominal Binder "ON"

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Exercise Endurance Time (EET)	Patients will be followed until all study visits are complete, an expected average of 2 weeks

Trial Locations

Locations (1)

Montreal Chest Institute; McGill University Health Center & McGill University; 🇨🇦 Montreal, Quebec, Canada