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Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion (FISIOPLEURA)

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ClinicalTrials.gov Identifier: NCT02359383
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Icastillo, Hospital de Granollers

Brief Summary:
Chest physiotherapy (CP) facilitates the absorption of fluid in the pleural cavity and reduces the formation of fibrous adhesions in patients with pleural infection, allowing a faster clinical, functional and radiological improve. The aim of the study is to determine if the CP associated with conventional medical treatment (CT) improves functional sequelae secondary to pleural infectious.

Condition or disease Intervention/treatment Phase
Pleural Diseases Infection Other: Chest physiotherapy Not Applicable

Detailed Description:
This is a multicenter, prospective and randomized trial. Objective: To determine if the Chest physiotherapy (CP) associated with conventional medical treatment (CT) improves functional sequelae secondary to pleural infectious disease, defined as an increased of 15% in Vital Functional Capacity (VFC). Adult patients with diagnosis of pleural infection will be included and randomized into two branches: control group - only CT and interventional one - CT plus CP.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion
Study Start Date : January 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Chest Physiotherapy group
Conventional medical treatment plus Chest Physiotherapy
Other: Chest physiotherapy
Depending on the location of the pleural effusion different techniques are performed: 1. Postural control techniques; 2. Secretions drainage techniques; 3. Thoracic expansion techniques; 4. Diaphragmatic mobility techniques.

No Intervention: Control grup
Conventional medical treatment



Primary Outcome Measures :
  1. Change in improving lung function [ Time Frame: 3 months ]
    To determine if Respiratory Physiotherapy (RP) associated with conventional medical treatment (CT) improves functional sequelae secondary to infectious pleural effusion. All patients will performed spirometric studies at the beginning of the study, at 3 and 6 month.


Secondary Outcome Measures :
  1. Change in resolution of pleural effusion [ Time Frame: 3 months ]
    To analysed if CP allows faster resolution of pleural effusion. A simple thoracic Rx will be performed to assess radiological changes every month till resolution of pleural sequelae.

  2. Reduce hospital stay [ Time Frame: 3 months ]
    To assess if CP added to medical therapy in patients with infectious pleural effusion decreased hospital stay



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of infectious pleural effusion
  • Failure to meet any exclusion criteria.

Exclusion Criteria:

  • Hemothorax.
  • Malignant pleural effusion.
  • Severe comorbidities (end-stage disease, neuromuscular diseases, etc)
  • Previous ribcage and/or diaphragmatic pathology.
  • Pregnancy.
  • Previous respiratory rehabilitation program completed.
  • Prior pleural pathology

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 ClinicalTrials.gov identifier (NCT number): NCT02359383


Contacts
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Contact: Inmaculada Castillo +348425000 ext 2675 icastillo@fhag.es

Locations
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Spain
Inmaculada Castillo Recruiting
Granollers, Barcelona, Spain, 08401
Contact: Inmaculada Castillo    +348425000 ext 2675    icastillo@fhag.es   
Sponsors and Collaborators
Hospital de Granollers
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Inmaculada Castillo Hospital General de Granollers

Publications:
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Responsible Party: Icastillo, Respiratory Therapist, Hospital de Granollers
ClinicalTrials.gov Identifier: NCT02359383     History of Changes
Other Study ID Numbers: 20133001
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Keywords provided by Icastillo, Hospital de Granollers:
pleural disease
infecTion
chest physiotherapy

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases