Combined Use of Respiratory Devices After Thoracic Surgery
NCT ID: NCT01510275
Last Updated: 2012-10-26
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
60 participants
INTERVENTIONAL
2010-10-31
2012-06-30
Brief Summary
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Detailed Description
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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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Intervention
Combined use of RESPIVOL® and RESPILIFT® (with resistive load)
Combined use of RESPIVOL® and RESPILIFT®
Active devices (combined) for 14 consecutive session, bid, for 15 minutes.
Control
Combined use of RESPIVOL® and RESPILIFT® (without resistive load)
Combined use of RESPIVOL® and RESPILIFT®
Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.
Interventions
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Combined use of RESPIVOL® and RESPILIFT®
Active devices (combined) for 14 consecutive session, bid, for 15 minutes.
Combined use of RESPIVOL® and RESPILIFT®
Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.
Eligibility Criteria
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Inclusion Criteria
* recent cardio-thoracic surgery (\< 30 days of admission)
* compliance to pulmonary rehabilitation program
Exclusion Criteria
* concomitant severe co-morbidities
* inability to use respiratory devices
19 Years
80 Years
ALL
No
Sponsors
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Villa Pineta Hospital
OTHER
Responsible Party
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Prof. Clini Enrico
Prof.
Principal Investigators
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Enrico E Clini, MD
Role: STUDY_DIRECTOR
University of Modena - Ospedale Villa Pineta
Locations
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Villa Pineta Hospital
Modena, Modena, Italy
Villa Pineta Hospital
Modena, Modena, Italy
Countries
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References
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Crisafulli E, Venturelli E, Siscaro G, Florini F, Papetti A, Lugli D, Cerulli M, Clini E. Respiratory muscle training in patients recovering recent open cardiothoracic surgery: a randomized-controlled trial. Biomed Res Int. 2013;2013:354276. doi: 10.1155/2013/354276. Epub 2013 Jul 30.
Other Identifiers
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VP-02-2010
Identifier Type: -
Identifier Source: org_study_id