Effects of Respiratory Physiotherapy on Pleural Effusion

Effectiveness of a Program of Respiratory Physiotherapy on Pleural Effusion: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion
• Intervention / Treatment: Other: Respiratory physiotherapy; Other: Conservative treatment

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Granada, Andalucia, Spain, 18012
      • Universitary Hospital San Cecilio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Respiratory physiotherapy; 54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.	Other: 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.; Other Names: Respiratory techniques added to conservative treatment
PLACEBO_COMPARATOR: Conservative treatment; 49 people were recruited in this group. These participants received conservative medical treatment intervention	Other: Conservative treatment; Conservative medical treatment intervention for pleural effusion.; Other Names: Medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the severity of respiratory disease	A spirometry is used to assess severity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second, and the forced expiratory flow over the middle one half of the forced vital capacity.	baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of the hospital stay	Length of stay was defined as the number of days between admission and discharge.	baseline, 12 months
Severity in the pleural effusion repercussion	The chest radiograph has been the initial diagnostic tool for the detection and evaluation of pleural effusion. The severity was codified from 0(normal) to 10 (very severe) by a radiologist with more than 8 years of experience.	baseline, 12 months.

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: M. Carmen Valenza, MD, Universidad de Granada

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (ESTIMATE): December 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 27, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Length of stay; Pleural Effusion; Respiratory physiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: DF0038UG