Abdominal Binding in Chronic Obstructive Pulmonary Disease

NCT01852006 | Completed

• 1 other identifier: RI MUHC 3234
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Exercise Endurance Time (EET)

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

Study Arms (2)

COPD AB ON

EXPERIMENTAL

Abdominal Binder "ON"

Device: Abdominal Binder

COPD AB OFF

NO INTERVENTION

Abdominal Binder "OFF" (control)

Interventions

Abdominal Binder DEVICE

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

Also known as: McDavid Inc., 493R Universal Back Support

COPD AB ON

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Montreal Chest Institute; McGill University Health Center & McGill University

Montreal, Quebec, H2X 2P4, Canada

Location

Related Publications (1)

• 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.

  PMID: 30487757 DERIVED

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Dennis Jensen, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 13, 2013
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

CA (1)