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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-3nm5bv |
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Date of registration:
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06/07/2011 |
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Primary sponsor: |
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Public title:
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Effects of physical exercises in lung cancer individuals
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Scientific title:
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Impact of pulmonary rehabilitation in the incidence of postoperative respiratory complications in pulmonary resection for lung cancer
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Date of first enrolment:
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01/01/2010 |
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Target sample size:
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30 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-3nm5bv/ |
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Study type:
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Study design:
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Clinical trial, randomized, phase 2-3, blind. The patients will be divided in 2 groups, GA (pulmonary rehabilitation) and GB (chest physical therapy).
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Maria
Morano |
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Address:
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Av. Frei Cirilo, 3480
60864190
Fortaleza
Brazil |
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Telephone:
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85 - 310140565 |
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Email:
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ttmorano@hotmail.com |
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Affiliation:
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HOSPITAL DE MESSEJANA DR. CARLOS ALBERTO STUDART GOMES - SESA/CE |
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Name:
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Maria
Morano |
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Address:
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Av. Frei Cirilo, 3480
60864190
Fortaleza
Brazil |
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Telephone:
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85 - 310140565 |
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Email:
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ttmorano@hotmail.com |
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Affiliation:
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HOSPITAL DE MESSEJANA DR. CARLOS ALBERTO STUDART GOMES - SESA/CE |
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Key inclusion & exclusion criteria
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Inclusion criteria: Staging of lung cancer among IA, IB, IIA, IIB and IIIA.
Medical Research Council (MRC)dyspnea scale at moderate to severe.
Candidate for pulmonary resection through thoracotomy.
Males and females aged greater than or equal to 38 years and less than or equal to 80 years.
Exclusion criteria: Severe cardiovascular or other diseases that contraindicate exercise;
Diseases with orthopedic impairments that preclude the exercise.
Age minimum:
38
Age maximum:
80
Gender:
-
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Health Condition(s) or Problem(s) studied
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Lung Cancer
Pre/post operative complication C04.588.894.797.520
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Intervention(s)
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Pulmonary resection Pulmonary Rehabilitation Conventional chest therapy physical exercise
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Primary Outcome(s)
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The primary endpoint will be evaluated by the post operative pulmonary complications (mechanical ventilation duration, days of intensive care unit, bronchospasm, atelectasis, bronchopleural fistula, empyema, pneumonia, tracheobronchitis, duration of chest tube, acute respiratory failure.
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Secondary Outcome(s)
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The secondary endpoint will be evaluated by pressure manovacuometry test (respiratory muscle strength)
, health related quality of life test (SF-36 questionnaire), six minutes walk distance test (physical capacity) and hospital anxiety and depression test (HADS - Hospital anxiety and depression scale).
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Source(s) of Monetary Support
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HOSPITAL DE MESSEJANA DR. CARLOS ALBERTO STUDART GOMES - SESA/CE - Brazil
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