Abdominal Binding in Chronic Obstructive Pulmonary Disease

August 24, 2015 updated by: Dennis Jensen, Ph.D., McGill University

Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 2P4
        • Montreal Chest Institute; McGill University Health Center & McGill University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • McDavid Inc., 493R Universal Back Support
No Intervention: COPD AB OFF
Abdominal Binder "OFF" (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Patients will be followed until all study visits are complete, an expected average of 2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 13, 2013

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RI MUHC 3234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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