Abdominal Binding in Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by McGill University
Sponsor:
Information provided by (Responsible Party):
Dennis Jensen, Ph.D., McGill University
ClinicalTrials.gov Identifier:
NCT01852006
First received: May 7, 2013
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Dyspnea
Device: Abdominal Binder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise Endurance Time (EET) [ Time Frame: Patients will be followed until all study visits are complete, an expected average of 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: McDavid Inc., 493R Universal Back Support
No Intervention: COPD AB OFF
Abdominal Binder "OFF" (control)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852006

Contacts
Contact: Dennis Jensen, Ph.D. 514-398-4184 ext 0572 dennis.jensen@mcgill.ca

Locations
Canada, Quebec
Montreal Chest Institute; McGill University Health Center & McGill University Recruiting
Montreal, Quebec, Canada, H2X 2P4
Contact: Dennis Jensen, Ph.D.    514-398-4184 ext 0572    dennis.jensen@mcgill.ca   
Principal Investigator: Dennis Jensen, Ph.D.         
Sub-Investigator: Jean Bourbeau, M.D., M.Sc.         
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Dennis Jensen, Ph.D. McGill University
  More Information

Additional Information:
No publications provided

Responsible Party: Dennis Jensen, Ph.D., Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT01852006     History of Changes
Other Study ID Numbers: RI MUHC 3234
Study First Received: May 7, 2013
Last Updated: January 30, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Dyspnea
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014