Effects of Respiratory Physiotherapy on Pleural Effusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01756742
First received: December 20, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Pleural Effusion
Other: Respiratory physiotherapy
Other: Conservative treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Program of Respiratory Physiotherapy on Pleural Effusion: a Randomized Controlled Trial

Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Assessment of the severity of respiratory disease [ Time Frame: baseline, 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Length of the hospital stay [ Time Frame: baseline, 12 months ] [ Designated as safety issue: Yes ]
    Length of stay was defined as the number of days between admission and discharge.

  • Severity in the pleural effusion repercussion [ Time Frame: baseline, 12 months. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 112
Study Start Date: February 2009
Study Completion Date: March 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Medical 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756742

Locations
Spain
Universitary Hospital San Cecilio
Granada, Andalucia, Spain, 18012
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: M. Carmen Valenza, MD Universidad de Granada
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, Assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01756742     History of Changes
Other Study ID Numbers: DF0038UG
Study First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
Pleural Effusion
Respiratory physiotherapy
Length of stay

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

ClinicalTrials.gov processed this record on July 20, 2014