NCT01546779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

6 months

First QC Date

February 19, 2012

Last Update Submit

March 1, 2012

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • lung function

    Forced expiratory maneuvers were measured before and 15 minutes after intervention.

    fifteen minutes after intervention

Study Arms (1)

lung function

EXPERIMENTAL
Device: Tri-Gym

Interventions

Tri-GymDEVICE

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.

Also known as: incentive spirometer
lung function

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cystic fibrosis patients

You may not qualify if:

  • i.v. antibiotic therapy during the experiment day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pediatric Pulmonary Unit the Edmond and LiliSafraChildrens Hospital, Sheba Medical Center

Ramat Gan, Israel, 52621, Israel

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2012

First Posted

March 7, 2012

Study Start

December 1, 2008

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

IL(1)