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Completed

NCT Number: NCT01852006

Abdominal Binding in Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Chest Institute; McGill University Health Center & McGill University

Montreal, Quebec, H2X 2P4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abdominal Binder

Device

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

Other names: McDavid Inc., 493R Universal Back Support

Primary outcomes

  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 outcomes

  1. Exercise Endurance Time (EET)

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

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

Abdominal Binding: a Novel Intervention to Relieve Dyspnea and Improve Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease?

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 13, 2013
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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