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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Diseases; Infection
• Intervention / Treatment: Other: Chest physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Granollers, Barcelona, Spain, 08401
      • Inmaculada Castillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in improving lung function	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in resolution of pleural effusion	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.	3 months
Reduce hospital stay	To assess if CP added to medical therapy in patients with infectious pleural effusion decreased hospital stay	3 months

Collaborators and Investigators

• Sponsor: Hospital de Granollers
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Inmaculada Castillo, Hospital General de Granollers

Publications and helpful links

General Publications

• Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.
• Villena Garrido V, Cases Viedma E, Fernandez Villar A, de Pablo Gafas A, Perez Rodriguez E, Porcel Perez JM, Rodriguez Panadero F, Ruiz Martinez C, Salvatierra Velazquez A, Valdes Cuadrado L. Recommendations of diagnosis and treatment of pleural effusion. Update. Arch Bronconeumol. 2014 Jun;50(6):235-49. doi: 10.1016/j.arbres.2014.01.016. Epub 2014 Mar 31. English, Spanish.
• Villena Garrido V, Ferrer Sancho J, Hernandez Blasco L, de Pablo Gafas A, Perez Rodriguez E, Rodriguez Panadero F, Romero Candeira S, Salvatierra Velazquez A, Valdes Cuadrado L; Area de Tecnicas y Trasplantes. SEPAR. [Diagnosis and treatment of pleural effusion]. Arch Bronconeumol. 2006 Jul;42(7):349-72. doi: 10.1016/s1579-2129(06)60545-4. No abstract available. Spanish.
• Skouras V, Awdankiewicz A, Light RW. What size parapneumonic effusions should be sampled? Thorax. 2010 Jan;65(1):91. doi: 10.1136/thx.2008.112797. No abstract available.
• Porcel JM, Light RW. [Parapneumonic pleural effusions and empyema in adults:current practice]. Rev Clin Esp. 2009 Nov;209(10):485-94. doi: 10.1016/s0014-2565(09)72634-7. Spanish.
• Colice GL, Curtis A, Deslauriers J, Heffner J, Light R, Littenberg B, Sahn S, Weinstein RA, Yusen RD. Medical and surgical treatment of parapneumonic effusions : an evidence-based guideline. Chest. 2000 Oct;118(4):1158-71. doi: 10.1378/chest.118.4.1158. Erratum In: Chest 2001 Jan;119(1):319.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: chest physiotherapy; pleural disease; infecTion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Effusion; Pleural Diseases
• Other Study ID Numbers: 20133001