Abdominal Binding in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852006
• Other study ID #: RI MUHC 3234
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: August 24, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Abdominal Binder
Abdominal Binding to increase end-expiratory gastric pressure by 5-8 centimetres of water at rest.

Locations

Country	Name	City	State
Canada	Montreal Chest Institute; McGill University Health Center & McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Exercise Endurance Time (EET)		Patients will be followed until all study visits are complete, an expected average of 2 weeks	No

External Links

•   Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University