Clinical trial NCT01852006: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Dyspnea
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime during exercise
timeFrame: Patients will be followed until all study visits are complete, an expected average of 2 weeks
Secondary outcomes:
measure: Exercise Endurance Time (EET)
timeFrame: Patients will be followed until all study visits are complete, an expected average of 2 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Chest Institute; McGill University Health Center & McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Dennis Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.