Abdominal Binding in Chronic Obstructive Pulmonary Disease

NCT ID: NCT01852006

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COPD AB ON

Abdominal Binder "ON"

Group Type EXPERIMENTAL

Abdominal Binder

Intervention Type DEVICE

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

COPD AB OFF

Abdominal Binder "OFF" (control)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Abdominal Binder

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

Intervention Type DEVICE

Other Intervention Names

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McDavid Inc., 493R Universal Back Support

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University

OTHER

Sponsor Role lead

Responsible Party

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Dennis Jensen, Ph.D.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis Jensen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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Montreal Chest Institute; McGill University Health Center & McGill University

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30487757 (View on PubMed)

Related Links

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http://www.mcgill.ca/cerpl

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

Other Identifiers

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RI MUHC 3234

Identifier Type: -

Identifier Source: org_study_id

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