Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease (DMCOPD)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00870246
First received: March 26, 2009
Last updated: May 5, 2009
Last verified: May 2009
  Purpose

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).


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Official Title: Influence of Diaphragmatic Mobility on the Exercise Capacity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • spirometer, capacity of exercise, dyspnea [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • diaphragm mobility: the craniocaudal excursion of the intrahepatic branches of the portal vein with the B-mode ultrasound [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: February 2008
Study Completion Date: November 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
High mobility
2
Lower mobility

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Sixty patients with moderate or severe COPD were evaluated.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870246

Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Celso Carvalho, professor Sao Paulo University
  More Information

No publications provided

Responsible Party: Celso Ricardo Fernandes de Carvalho, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00870246     History of Changes
Other Study ID Numbers: 914/04
Study First Received: March 26, 2009
Last Updated: May 5, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
COPD
pulmonary emphysema

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014