Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2011-09-30
2017-03-31
Brief Summary
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Primary objective:
-To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo.
Secondary objectives:
* To evaluate the level of knowledge of airway clearance techniques and adherence to them in patients with bronchiectasis.
* To assess the side effects during the procedure: oxygen desaturation, increased dyspnea and hemoptysis.
Detailed Description
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The mucociliary clearance mechanism is impaired in these patients, and chest physiotherapy has been recommended for patients with bronchiectasis and chronic productive cough and/or evidence of mucus plugging on HRCT.
However, to date, there is insufficient evidence of benefits of chest physiotherapy through randomised controlled trials. Furthermore it rests unclear the most effective technique, the frequency and optimum duration of the RP and the most suitable variables to monitor.
A multicenter clinical trial into the efficacy of one chest physiotherapy technique in airway clearance will fill this important "gap" in the scientific evidence.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Airway clearance, bronchiectasis
The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist.
Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary.
Low Expiration Open glottis inferolateral (ELTGOL)
Place the affected lung in infralateral, asks the patient to make an inspiration without being forced to medium volume, and then a slow expiration with the glottis open, down to residual volume. If the therapist is present place the abdominal caudal hand at putting pressure cranial head and hand is placed over the rib cage at a pressure of closing the rib cage. Otherwise, the patient self-administered intertwining arms and abdominal rib at top exerting the same pressure. In case you have two lungs affected the art will take place on one side and then the opposite.
bronchiectasis, stretching
The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist.
Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary.
Stretching
Patient will be instructed to do muscle stretching of the thorax
Interventions
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Low Expiration Open glottis inferolateral (ELTGOL)
Place the affected lung in infralateral, asks the patient to make an inspiration without being forced to medium volume, and then a slow expiration with the glottis open, down to residual volume. If the therapist is present place the abdominal caudal hand at putting pressure cranial head and hand is placed over the rib cage at a pressure of closing the rib cage. Otherwise, the patient self-administered intertwining arms and abdominal rib at top exerting the same pressure. In case you have two lungs affected the art will take place on one side and then the opposite.
Stretching
Patient will be instructed to do muscle stretching of the thorax
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of bronchiectasis using a high-resolution computed tomography (HRCT) chest scan performed in the last 2 years.
* Clinically stable disease (defined as no requirement for antibiotics for exacerbation in the 4 weeks preceding study entry.
* Chronic sputum expectoration \>10ml/24h.
Exclusion Criteria
* Inability to perform physiotherapy techniques.
* Inability to attend the following controls.
* Treatment with mucolytics, DNase or hypertonic saline during the study.
* Smokers and ex-smokers ≥ 10 pack/year.
18 Years
95 Years
ALL
No
Sponsors
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Spanish Clinical Research Network - SCReN
NETWORK
Sociedad Española de Neumología y Cirugía Torácica
OTHER
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
OTHER
Responsible Party
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Dr. Montserrat Vendrell Relat
Pneumology Doctor
Principal Investigators
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Montserrat V Relat, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Locations
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Hospital Universitari Dr. Josep Trueta
Girona, , Spain
Countries
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References
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Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan.
Other Identifiers
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08/10
Identifier Type: -
Identifier Source: org_study_id