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Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease (DMCOPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, pulmonary emphysema

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 26, 2009
    Last Updated
    May 5, 2009
    Sponsor
    University of Sao Paulo
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    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

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    Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease

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