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Abdominal Binding in Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease, Dyspnea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Abdominal Binder
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Montreal Chest Institute; McGill University Health Center & McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

COPD AB ON

COPD AB OFF

Arm Description

Abdominal Binder "ON"

Abdominal Binder "OFF" (control)

Outcomes

Primary Outcome Measures

Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise

Secondary Outcome Measures

Exercise Endurance Time (EET)

Full Information

First Posted
May 7, 2013
Last Updated
August 24, 2015
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT01852006
Brief Title
Abdominal Binding in Chronic Obstructive Pulmonary Disease
Official Title
Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD AB ON
Arm Type
Experimental
Arm Description
Abdominal Binder "ON"
Arm Title
COPD AB OFF
Arm Type
No Intervention
Arm Description
Abdominal Binder "OFF" (control)
Intervention Type
Device
Intervention Name(s)
Abdominal Binder
Other Intervention Name(s)
McDavid Inc., 493R Universal Back Support
Intervention Description
Abdominal Binding to increase end-expiratory gastric pressure by 5-8 centimetres of water at rest.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Exercise Endurance Time (EET)
Time Frame
Patients will be followed until all study visits are complete, an expected average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Chest Institute; McGill University Health Center & McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30487757
Citation
Abdallah SJ, Smith BM, Wilkinson-Maitland C, Li PZ, Bourbeau J, Jensen D. Effect of Abdominal Binding on Diaphragmatic Neuromuscular Efficiency, Exertional Breathlessness, and Exercise Endurance in Chronic Obstructive Pulmonary Disease. Front Physiol. 2018 Nov 14;9:1618. doi: 10.3389/fphys.2018.01618. eCollection 2018.
Results Reference
derived
Links:
URL
http://www.mcgill.ca/cerpl
Description
Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University

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Abdominal Binding in Chronic Obstructive Pulmonary Disease

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