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Abdominal Binding in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT01852006
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Dennis Jensen, Ph.D., McGill University

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Dyspnea Device: Abdominal Binder Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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?
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: McDavid Inc., 493R Universal Back Support
No Intervention: COPD AB OFF
Abdominal Binder "OFF" (control)



Primary Outcome Measures :
  1. 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 Measures :
  1. Exercise Endurance Time (EET) [ Time Frame: Patients will be followed until all study visits are complete, an expected average of 2 weeks ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852006


Locations
Canada, Quebec
Montreal Chest Institute; McGill University Health Center & McGill University
Montreal, Quebec, Canada, H2X 2P4
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Dennis Jensen, Ph.D. McGill University

Additional Information:
Responsible Party: Dennis Jensen, Ph.D., Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT01852006     History of Changes
Other Study ID Numbers: RI MUHC 3234
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

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