Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease (DMCOPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, pulmonary emphysema
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
1
2
Arm Description
High mobility
Lower mobility
Outcomes
Primary Outcome Measures
spirometer, capacity of exercise, dyspnea
Secondary Outcome Measures
diaphragm mobility: the craniocaudal excursion of the intrahepatic branches of the portal vein with the B-mode ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00870246
Brief Title
Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease
Acronym
DMCOPD
Official Title
Influence of Diaphragmatic Mobility on the Exercise Capacity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Observational
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, pulmonary emphysema
7. Study Design
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Description
High mobility
Arm Title
2
Arm Description
Lower mobility
Primary Outcome Measure Information:
Title
spirometer, capacity of exercise, dyspnea
Time Frame
3 months
Secondary Outcome Measure Information:
Title
diaphragm mobility: the craniocaudal excursion of the intrahepatic branches of the portal vein with the B-mode ultrasound
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
Sixty patients with moderate or severe COPD were evaluated.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso Carvalho, professor
Organizational Affiliation
Sao Paulo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease
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