Cystic FibrosisNCT01546779
The Use of Visual Feedback in Airway Clearance
A study testing Tri-Gym in people with Cystic Fibrosis, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tri-Gym
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cystic fibrosis patients
Who cannot join
- i.v. antibiotic therapy during the experiment day
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Pediatric Pulmonary Unit the Edmond and LiliSafraChildrens Hospital, Sheba Medical Center
Ramat Gan, Israel, 52621
About this study
Official title: The Immediate Effect of Resistive Expiration Via "Volumetric Incentive Spirometer" on Lung Function in Patients With Cystic Fibrosis.
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Tri-Gym
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-GymDevice
Also called incentive spirometer
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.
| Study group | Role | What they receive |
|---|---|---|
| lung function | Experimental | Not described Receives: Device: Tri-Gym |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung function
Forced expiratory maneuvers were measured before and 15 minutes after intervention.
Measured: fifteen minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546779
- Sponsor's protocol ID
- SHEBA-08-5583-OE-CTIL
- Status last verified
- Mar 2012
- First submitted
- 19 Feb 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Resistive Expiration Via "Volumetric Incentive Spirometer" on Lung Function in Patients With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT01546779
- Acronym / sponsor ID
- SHEBA-08-5583-OE-CTIL
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung function | Experimental | Device: Tri-Gym |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cystic fibrosis patients
Key exclusion criteria (1 listed)
- i.v. antibiotic therapy during the experiment day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tri-GymAlso: incentive spirometer40 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. | Device | lung function |
Primary outcome
lung function
Time frame: fifteen minutes after intervention
Forced expiratory maneuvers were measured before and 15 minutes after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tri-Gym in people with Cystic Fibrosis, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung function (time frame: fifteen minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.