Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency). (FLUTTER®VRP1)
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Purpose
The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchiectasis |
Other: control group Other: Flutter group Other: PEP group Other: Group Sham |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis. |
- The Effect of FLUTTER VRP1 on respiratory mucus transport [ Time Frame: five years ] [ Designated as safety issue: No ]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).
| Enrollment: | 30 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Flutter group
In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland).
|
Other: Flutter group
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).
Other Name: Futter VRP1 device without modification
|
|
Active Comparator: PEP group
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
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).
Other Name: Flutter VRP1 without the ball inside
|
|
Placebo Comparator: control group
In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions
|
Other: control group
In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.
Other Name: group without therapy
|
|
Sham Comparator: Group Sham
Exercise with Flutter®VRP1 without the ball inside
|
Other: Group Sham
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)
Other Name: Group Sham
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Brazil | |
| Faculty of Medicine of Ribeirão Preto, University of Sao Paulo | |
| Ribeirão Preto, São Paulo, Brazil, 14049-900 | |
| Study Chair: | Ada C. Gastaldi, doctor | University of Sao Paulo |
More Information
Additional Information:
Publications:
| Responsible Party: | Ada Clarice Gastaldi, Professor Ada Clarice Gastaldi, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01209546 History of Changes |
| Other Study ID Numbers: | USP 2010-2 |
| Study First Received: | July 12, 2010 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by University of Sao Paulo:
|
Bronchiectasis Pulmonary function Respiratory muscle strength Respiratory secretions |
Additional relevant MeSH terms:
|
Bronchiectasis Bronchial Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013