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Completed

NCT Number: NCT00870246

Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the influence of diaphragm mobility on exercise capacity and dyspnoea in patients with chronic obstructive pulmonary disease (COPD).

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Key information

About this study

Chronic Obstructive Pulmonary Disease (COPD) is characterized by progressive obstruction of the airways which is partially irreversible. COPD patients commonly present increased resistance to airflow, air trapping, and pulmonary hyperinflation that alters the chest wall placing the respiratory muscles in mechanical disadvantage, thereby increasing both respiratory drive and the sensation of dyspnoea. Furthermore, to prevent dyspnoea, COPD patients reduce their daily living activities leading to loss of physical condition, social isolation, depression and anxiety,whilst compromising their quality of life.

Forced expiratory volume in one second (FEV1) is the main parameter used to establish the severity of pulmonary impairment and disease progression.

Nevertheless, some studies have suggested that FEV1 does not adequately reflect the clinical manifestations of the disease and is only weakly associated with the severity of dyspnoea, health related quality of life (HRQOL) features, and the ability to perform activities of daily living.

Moreover, FEV1 appears not to be a predictor of mortality in COPD patients. Pulmonary hyperinflation has been related with adaptation in diaphragm muscle maintaining the muscle's capacity to generate power whilst reducing its displacement. The importance of the diaphragm in lung mechanics associated with hyperinflation has been the subject of frequent discussion owing to widespread use of lung volume reducing surgery which results in increased movement range of the diaphragm muscle. However, to date, the relationship between diaphragm mobility and functional capacity in COPD patients remains unknown.

The objective of the present study was to evaluate the influence of diaphragm mobility in the exercise capacity and dyspnoea of patients with COPD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with chronic obstructive pulmonary disease clinically stable (no respiratory crises or hospitalizations within the 30 days preceding the study outset)
  • patients receiving optimized clinical medical treatment

Exclusion criteria

  • patients suffering from other cardiorespiratory diseases
  • patients with oxygen-dependent for any reason
  • patients classified as obese or as underweight
  • patients presenting other respiratory diseases or pleural scars on chest X-rays

Treatment and study plan

Primary outcomes

  1. spirometer, capacity of exercise, dyspnea

    Time frame: 3 months

Secondary outcomes

  1. diaphragm mobility: the craniocaudal excursion of the intrahepatic branches of the portal vein with the B-mode ultrasound

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Influence of Diaphragmatic Mobility on the Exercise Capacity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease

Acronym: DMCOPD

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2009
Registry last updated
May 6, 2009

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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