Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency).

Study Overview
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Brief Summary
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The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.

Detailed Description
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Bronchiectasis is an airway disease with many etiologies characterized pathologically by the abnormal permanent dilatation of bronchi, caused mainly by the perpetuation of inflammatory processes induced by frequent episodes of bacterial infections, with consequent change in the ciliated epithelial lining and compromising the effectiveness of mucociliary clearance that can favor the hypersecretive state found in these patients. In addition to drug therapy or surgical treatment, patients with bronchiectasis also have physiotherapy, which is an important part in treatment. The patients present impaired mucus transport, and can enjoy the benefits provided by respiratory therapy, which features intended to increase the removal of airway secretions and thus reduce the obstruction to improve ventilation and oxygenation. One of the instruments commonly used in respiratory therapy is the Flutter ® VRP1 (VarioRaw SA, Switzerland), which is a simple equipment, small, similar to a pipe that combines two techniques: positive expiratory pressure (PEP) and high-frequency oscillations. Some previous studies have shown beneficial effects after use of this device in patients with bronchiectasis. However, it is unclear whether the mechanism of action is related to the combination of PEP and the techniques of high frequency oscillation, or just one of those components.

Official Title
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Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.

Conditions
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Bronchiectasis

Intervention / Treatment
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* Other: control group
* Other: Flutter group
* Other: PEP group
* Other: Group Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non Cystic Fibrosis Bronchiectasis Amount of secretion sufficient for analysis Capable of fulfilling the experimental protocol Exclusion Criteria: Acute pulmonary disease Presence of any respiratory infection in the last four weeks

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flutter group<br>In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland). | Other: Flutter group<br>* Patients have done exercise sessions with Flutter ®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP).<br>* Other names: Futter VRP1 device without modification;|
| Active Comparator: PEP group<br>In PEP group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland) without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1. | Other: PEP group<br>* Patients have done exercise sessions with Flutter® VRP1 without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (Flutter®VRP1).<br>* Other names: Flutter VRP1 without the ball inside;|
| Placebo Comparator: control group<br>In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions | Other: control group<br>* In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.<br>* Other names: group without therapy;|
| Sham Comparator: Group Sham<br>Exercise with Flutter®VRP1 without the ball inside | Other: Group Sham<br>* Patients have done exercise sessions with Flutter ®VRP1 for 30 minutes without the ball inside daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of FLUTTER VRP1 on respiratory mucus transport | 30 patients with bronchiectasis will receive sessions with the Flutter®VRP1 or PEP for 30 minutes daily in a randomized, crossover study. Weekly secretion samples will be collected and evaluated for mucociliary relative transport velocity(RTV), displacement in a simulated cough machine(SCM) and contact angle measurement(CAM). | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiectasis, Pulmonary function, Respiratory muscle strength, Respiratory secretions