Pleural DiseasesFISIOPLEURANCT02359383
Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion
A study testing Chest physiotherapy in people with Pleural Diseases and Infection, run by Hospital de Granollers at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pleural Diseases, Infection
- What is being tested?
- Chest physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of infectious pleural effusion
- Failure to meet any exclusion criteria.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pleural Diseases, Infection
- Being tested
- Chest physiotherapy
- Keywords
- pleural disease, infecTion, chest physiotherapy
- Medical subject headings
- Pleural Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Chest Physiotherapy group | Active comparator | Conventional medical treatment plus Chest Physiotherapy Receives: Other: Chest physiotherapy |
| Control grup | No intervention | Conventional medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Reduce hospital stay
To assess if CP added to medical therapy in patients with infectious pleural effusion decreased hospital stay
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Icastillo, Hospital de Granollers
- Investigators
- Inmaculada Castillo, Principal investigator, Hospital General de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359383
- Sponsor's protocol ID
- 20133001
- Acronym
- FISIOPLEURA
- Status last verified
- Aug 2022
- First submitted
- 28 Jan 2015
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24698396Villena 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.
PubMed 16945266Skouras 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.
PubMed 20029043Porcel 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.
PubMed 19889319Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.
PubMed 16493154Colice 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.
PubMed 11035692
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion
- ClinicalTrials.gov ID
- NCT02359383
- Acronym / sponsor ID
- FISIOPLEURA / 20133001
- Conditions
- Pleural Diseases, Infection
- Keywords
- pleural disease, infecTion, chest physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- Jan 2014
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest Physiotherapy group | Active comparator | Other: Chest physiotherapyConventional medical treatment plus Chest Physiotherapy |
| Control grup | No intervention | –Conventional medical treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of infectious pleural effusion
- Failure to meet any exclusion criteria.
Key exclusion criteria (7 listed)
- Hemothorax.
- Malignant pleural effusion.
- Severe comorbidities (end-stage disease, neuromuscular diseases, etc)
- Previous ribcage and/or diaphragmatic pathology.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest physiotherapyDepending 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. | Other | Chest Physiotherapy group |
Primary outcome
Change in improving lung function
Time frame: 3 months
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.
2 secondary outcomes
Change in resolution of pleural effusion
Time frame: 3 months
Reduce hospital stay
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 24698396Villena 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.
- Background: PubMed 16945266Villena 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.
- Background: PubMed 20029043Skouras 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.
- Background: PubMed 19889319Porcel 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.
- Background: PubMed 16493154Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.
- Background: PubMed 11035692Colice 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.
Related trials for Pleural Diseases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inmaculada Castillo principal investigator
Hospital General de Granollers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy in people with Pleural Diseases and Infection, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in improving lung function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359383, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.