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Completed

NCT Number: NCT02359383

Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion

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.

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Key information

Conditions

Pleural Diseases Infection Infections Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inmaculada Castillo

Granollers, Barcelona, 08401, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chest physiotherapy

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital de Granollers

Other

Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Registry information

Acronym: FISIOPLEURA

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2015
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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