NCT02359383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

8.4 years

First QC Date

January 28, 2015

Last Update Submit

August 3, 2022

Conditions

Pleural DiseasesInfection

Keywords

pleural diseaseinfecTionchest physiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in resolution of pleural effusion

    3 months

  • Reduce hospital stay

    3 months

Study Arms (2)

Chest Physiotherapy group

ACTIVE COMPARATOR

Conventional medical treatment plus Chest Physiotherapy

Other: Chest physiotherapy

Control grup

NO INTERVENTION

Conventional medical treatment

Interventions

Chest physiotherapyOTHER

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.

Chest Physiotherapy group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of infectious pleural effusion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inmaculada Castillo

Granollers, Barcelona, 08401, Spain

Location

Related Publications (6)

  • 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.

    PMID: 24698396BACKGROUND

  • 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.

    PMID: 16945266BACKGROUND

  • 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.

    PMID: 20029043BACKGROUND

  • 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.

    PMID: 19889319BACKGROUND

  • Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.

    PMID: 16493154BACKGROUND

  • 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.

    PMID: 11035692BACKGROUND

MeSH Terms

Conditions

Pleural DiseasesInfections

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Inmaculada Castillo

    Hospital General de Granollers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Therapist

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 10, 2015

Study Start

January 1, 2014

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations

ES(1)