NCT01756742

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2012

Completed
Last Updated

December 27, 2012

Status Verified

December 1, 2012

Enrollment Period

1.9 years

First QC Date

December 20, 2012

Last Update Submit

December 20, 2012

Conditions

Pleural Effusion

Keywords

Pleural EffusionRespiratory physiotherapyLength of stay

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Length of the hospital stay

    baseline, 12 months

  • Severity in the pleural effusion repercussion

    baseline, 12 months.

Study Arms (2)

Respiratory physiotherapy

EXPERIMENTAL

54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.

Other: Respiratory physiotherapy

Conservative treatment

PLACEBO COMPARATOR

49 people were recruited in this group. These participants received conservative medical treatment intervention

Other: Conservative treatment

Interventions

Respiratory physiotherapyOTHER

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.

Also known as: Respiratory techniques added to conservative treatment
Respiratory physiotherapy
Conservative treatmentOTHER

Conservative medical treatment intervention for pleural effusion.

Also known as: Medical treatment
Conservative treatment

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Non diagnosis of pleural effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitary Hospital San Cecilio

Granada, Andalusia, 18012, Spain

Location

MeSH Terms

Conditions

Pleural Effusion

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • M. Carmen Valenza, MD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 20, 2012

First Posted

December 27, 2012

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

March 1, 2012

Last Updated

December 27, 2012

Record last verified: 2012-12

Locations

ES(1)