Abdominal Binding in Chronic Obstructive Pulmonary Disease

McGill University

Status: Completed

Conditions: Dyspnea; Chronic Obstructive Pulmonary Disease

Treatments: Device: Abdominal Binder

Study type: Interventional

Funder types: Other

Identifiers

NCT01852006

RI MUHC 3234

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

COPD AB ON

Experimental group

Description:

Abdominal Binder "ON"

Treatment:

Device: Abdominal Binder

COPD AB OFF

No Intervention group

Description:

Abdominal Binder "OFF" (control)