EmphysemaNCT04347044
The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success
A study testing Pulmonary Rehabilitation and Standart care in people with Emphysema and Pulmonary Rehabilitation, run by Istanbul Medipol University Hospital.
Trial summary
The data of patients undergoing bronchoscopic volume reduction procedure will be analyzed retrospectively. Patients will be divided into two groups as patients with and without Pulmonary Rehabilitation before the procedure, and changes in functional levels of patients will be compared. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Emphysema, Pulmonary Rehabilitation, Bronchoscopic Lung Volume Reduction
- What is being tested?
- Pulmonary Rehabilitation and Standart care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 18 Aug 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-75
- Patients with a diagnosis of emphysema and bronchoscopic procedures
Who cannot join
- Patients who develop complications related to the procedure after bronchoscopic procedure.
About this study
The data of patients undergoing bronchoscopic volume reduction procedure will be analyzed retrospectively. Patients will be divided into two groups as patients with and without Pulmonary Rehabilitation before the procedure, and changes in functional levels of patients will be compared.
Read the detailed description
The data of patients who underwent bronchoscopic volume reduction between January 2013 and March 2019 will be examined.
Patients will be divided into two groups as pulmonary rehabilitation applied (PR group) and not applied (Control group) before the procedure.
Changes in the parameters of initial and rehabilitation follow-up will be examined.
- Being tested
- Pulmonary Rehabilitation, Standart care
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
Exercise training+ Optimal medication and clinical follow-up
Standart careOther
Optimal medication and clinical follow-up
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation Group | Experimental | Optimal medication and clinical follow-up plus Pulmonary rehabiltation Receives: Other: Pulmonary Rehabilitation; Other: Standart care |
| Non-Pulmonary Rehabilitation Group | Active comparator | Optimal medication and clinical follow-up Receives: Other: Standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walking test
The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were asked to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating were measured, and the walking distance were recorded
Measured: 20 minutes
Pulmonary Function Tests
PFTs were performed by using the Sensormedics model 2400 (Yorba Linda, CA, USA) spirometry device, and according to the American Thoracic Society (ATS) guidelines
Measured: 15 minutes
Secondary outcomes (1)
Carbonmonoxide diffusion test
It will performed in the pulmonary function test laboratory using Cosmed Quark PFT (USA) with single-breath technique
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Jan 2013
- Primary completion18 Aug 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347044
- Sponsor's protocol ID
- BLVR_PR
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success
- ClinicalTrials.gov ID
- NCT04347044
- Acronym / sponsor ID
- BLVR_PR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- 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.
The data of patients undergoing bronchoscopic volume reduction procedure will be analyzed retrospectively. Patients will be divided into two groups as patients with and without Pulmonary Rehabilitation before the procedure, and changes in functional levels of patients will be compared.
Detailed description
The data of patients who underwent bronchoscopic volume reduction between January 2013 and March 2019 will be examined.
Patients will be divided into two groups as pulmonary rehabilitation applied (PR group) and not applied (Control group) before the procedure.
Changes in the parameters of initial and rehabilitation follow-up will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation Group | Experimental | Other: Pulmonary Rehabilitation, Other: Standart careOptimal medication and clinical follow-up plus Pulmonary rehabiltation |
| Non-Pulmonary Rehabilitation Group | Active comparator | Other: Standart careOptimal medication and clinical follow-up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 18-75
- Patients with a diagnosis of emphysema and bronchoscopic procedures
Key exclusion criteria (1 listed)
- Patients who develop complications related to the procedure after bronchoscopic procedure.
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 |
|---|---|---|
| Pulmonary RehabilitationExercise training+ Optimal medication and clinical follow-up | Other | Pulmonary Rehabilitation Group |
| Standart careOptimal medication and clinical follow-up | Other | Non-Pulmonary Rehabilitation Group, Pulmonary Rehabilitation Group |
Primary outcome
Six minute walking test
Time frame: 20 minutes
The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were asked to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating were measured, and the walking distance were recorded
Pulmonary Function Tests
Time frame: 15 minutes
PFTs were performed by using the Sensormedics model 2400 (Yorba Linda, CA, USA) spirometry device, and according to the American Thoracic Society (ATS) guidelines
1 secondary outcome
Carbonmonoxide diffusion test
Time frame: 15 minutes
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 19 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation and Standart care in people with Emphysema and Pulmonary Rehabilitation, run by Istanbul Medipol University Hospital.
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 2 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Six minute walking test (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 19 Aug 2020.