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Effects of Respiratory Physiotherapy on Pleural Effusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756742
Recruitment Status : Completed
First Posted : December 27, 2012
Last Update Posted : December 27, 2012
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Brief Summary:
Pleural effusion and the complexity of diagnosis and treatment make planning and delivering care challenging. Respiratory physiotherapy is recommended, and should be applied during the first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a University Hospital.

Condition or disease Intervention/treatment Phase
Pleural Effusion Other: Respiratory physiotherapy Other: Conservative treatment Not Applicable

Detailed Description:
Approximately 1.5 million patients are diagnosed with pleural effusion each year in the United States . Pleural effusion (PE) is an accumulation of fluid in the pleural space that is classified as transudate or exudate according to its composition and underlying pathophysiology. The goal in the management of pleural effusion is to provide symptomatic relief by removing fluid from the pleural space and to allow the treatment of the underlying disease. While some authors (REF) propose respiratory physiotherapy, in the majority of the cases only the medical treatment combined with the pleural fluid removal by thoracentesis are the most common practice. The objective of this study is verify the effectiveness of respiratory physiotherapy in pleural effusion

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Program of Respiratory Physiotherapy on Pleural Effusion: a Randomized Controlled Trial
Study Start Date : February 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: Respiratory physiotherapy
54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.
Other: Respiratory physiotherapy

The respiratory physiotherapy intervention included:

  • Mobilisation techniques: limb exercises (passive, active assisted, or active resisted)
  • Chest physiotherapy: it included a Controlled breathing program, pursed lips breathing (PLB), active expiration and incentive spirometry.
Other Name: Respiratory techniques added to conservative treatment

Placebo Comparator: Conservative treatment
49 people were recruited in this group. These participants received conservative medical treatment intervention
Other: Conservative treatment
Conservative medical treatment intervention for pleural effusion.
Other Name: Medical treatment

Primary Outcome Measures :
  1. Assessment of the severity of respiratory disease [ Time Frame: baseline, 12 months ]
    A spirometry is used to assess severity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second, and the forced expiratory flow over the middle one half of the forced vital capacity.

Secondary Outcome Measures :
  1. Length of the hospital stay [ Time Frame: baseline, 12 months ]
    Length of stay was defined as the number of days between admission and discharge.

  2. Severity in the pleural effusion repercussion [ Time Frame: baseline, 12 months. ]
    The chest radiograph has been the initial diagnostic tool for the detection and evaluation of pleural effusion. The severity was codified from 0(normal) to 10 (very severe) by a radiologist with more than 8 years of experience.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of pleural effusion based on the presence of a consistent radiological finding on simple posteroanterior and lateral chest X-rays, and decubitus lateral in cases of small PE.

Exclusion Criteria:

  • Non diagnosis of pleural effusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756742

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Universitary Hospital San Cecilio
Granada, Andalucia, Spain, 18012
Sponsors and Collaborators
Universidad de Granada
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Principal Investigator: M. Carmen Valenza, MD Universidad de Granada
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Responsible Party: Marie Carmen Valenza, Assistant professor, Universidad de Granada Identifier: NCT01756742    
Other Study ID Numbers: DF0038UG
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012
Keywords provided by Marie Carmen Valenza, Universidad de Granada:
Pleural Effusion
Respiratory physiotherapy
Length of stay
Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases