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Effects of Respiratory Physiotherapy on Pleural Effusion

NCT ID: NCT01756742

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Pleural Effusion

Keywords

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Pleural Effusion Respiratory physiotherapy Length of stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Respiratory physiotherapy

54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.

Group Type EXPERIMENTAL

Respiratory physiotherapy

Intervention Type OTHER

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.

Conservative treatment

49 people were recruited in this group. These participants received conservative medical treatment intervention

Group Type PLACEBO_COMPARATOR

Conservative treatment

Intervention Type OTHER

Conservative medical treatment intervention for pleural effusion.

Interventions

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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.

Intervention Type OTHER

Conservative treatment

Conservative medical treatment intervention for pleural effusion.

Intervention Type OTHER

Other Intervention Names

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Respiratory techniques added to conservative treatment Medical treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M. Carmen Valenza, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Universitary Hospital San Cecilio

Granada, Andalusia, Spain

Site Status

Countries

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Spain

Other Identifiers

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DF0038UG

Identifier Type: -

Identifier Source: org_study_id