Back to resultsThe Use of Visual Feedback in Airway Clearance
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tri-Gym
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- cystic fibrosis patients
Exclusion Criteria:
- i.v. antibiotic therapy during the experiment day
Sites / Locations
- The Pediatric Pulmonary Unit the Edmond and LiliSafraChildrens Hospital, Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lung function
Arm Description
Outcomes
Primary Outcome Measures
lung function
Forced expiratory maneuvers were measured before and 15 minutes after intervention.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01546779
Brief Title
The Use of Visual Feedback in Airway Clearance
Official Title
The Immediate Effect of Resistive Expiration Via "Volumetric Incentive Spirometer" on Lung Function in Patients With Cystic Fibrosis.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing strategies, to clear secretions from their lungs. Hand held devices may aid mucus expectoration, and also motivate the patient to manage by themselves. Our aims was to study if resistive expiration through "volumetric incentive spirometer" (VISex) can improve lung function in the short term in Cystic Fibrosis (CF) patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lung function
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tri-Gym
Other Intervention Name(s)
incentive spirometer
Intervention Description
40 CF patients performed airway clearance using the VISex, by exhaling against chosen resistance being motivated by visual feedback of raising colored balls. The level of resistance was set to cause longest expiration/volume, until mucus was transported from the peripheral to the central airways, to be expectorated by the subsequent cough.
Primary Outcome Measure Information:
Title
lung function
Description
Forced expiratory maneuvers were measured before and 15 minutes after intervention.
Time Frame
fifteen minutes after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cystic fibrosis patients
Exclusion Criteria:
i.v. antibiotic therapy during the experiment day
Facility Information:
Facility Name
The Pediatric Pulmonary Unit the Edmond and LiliSafraChildrens Hospital, Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Use of Visual Feedback in Airway Clearance
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