COPDNCT03252873
THE FACTORS AFFECTING THE ADHERENCE TO THE PULMONARY REHABILITATION PROGRAM IN COPD
An observational study of COPD, run by Izmir Katip Celebi University.
Trial summary
Investigators will compare the factors affecting the adherence to the outpatient pulmonary rehabilitation program in COPD patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- How many people
- 359 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to May 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All COPD patients refered to the pulmonary rehabilitation unit.
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: INVESTIGATION THE FACTORS AFFECTING THE ADHERENCE TO THE OUTPATIENT PULMONARY REHABILITATION PROGRAM IN COPD
Investigators will compare the factors affecting the adherence to the outpatient pulmonary rehabilitation program in COPD patients
Read the detailed description
Patients were referred to the Pulmonary Rehabilitation Unit and were recommended to participate in the exercise program by a team of experts included in this study.
Demographic and clinical characteristics of patients were recorded before the pulmonary rehabilitation program. All cases were evaluated by pulmonary function test, arterial blood gas analysis, six minute walking test, MMRC Dyspnea Scale. Causes that prevented program adaptation of those who did not participate in the program or who left the program were questioned. Patients completing the eight-week PR program will compare with those who did not complete the program or who did not start the program at the recommended time.
- Conditions
- COPD
- Keywords
- adherence, pulmonary rehabilitation, copd
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Test
FEV1 (%) FEV1 /FVC TLCO (%) FEV1 (%), FEV1 /FVC, TLCO (%)
Measured: 15 minutes
Secondary outcomes (5)
Blood Gase Analysis
PAO2, PaCO2, SaO2
Measured: 5 minutes
Six minute walk test
walking distance
Measured: 10 minutes
MMRC Dyspnea Scale
1-5
Measured: 5 minutes
SGRQ Questionnaire
Symptom-Activity-Impact- Total
Measured: 20 minutes
HAD Questionnaire
Anxiety- Depression score
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 posted17 Aug 2017
- Study startJan 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252873
- Sponsor's protocol ID
- IzmirKCU2
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION THE FACTORS AFFECTING THE ADHERENCE TO THE OUTPATIENT PULMONARY REHABILITATION PROGRAM IN COPD
- ClinicalTrials.gov ID
- NCT03252873
- Acronym / sponsor ID
- IzmirKCU2
- Conditions
- COPD
- Keywords
- adherence, pulmonary rehabilitation, copd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Aug 2017 (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.
Investigators will compare the factors affecting the adherence to the outpatient pulmonary rehabilitation program in COPD patients
Detailed description
Patients were referred to the Pulmonary Rehabilitation Unit and were recommended to participate in the exercise program by a team of experts included in this study.
Demographic and clinical characteristics of patients were recorded before the pulmonary rehabilitation program. All cases were evaluated by pulmonary function test, arterial blood gas analysis, six minute walking test, MMRC Dyspnea Scale. Causes that prevented program adaptation of those who did not participate in the program or who left the program were questioned. Patients completing the eight-week PR program will compare with those who did not complete the program or who did not start the program at the recommended time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All COPD patients refered to the pulmonary rehabilitation unit.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Function Test
Time frame: 15 minutes
FEV1 (%) FEV1 /FVC TLCO (%) FEV1 (%), FEV1 /FVC, TLCO (%)
5 secondary outcomes
Blood Gase Analysis
Time frame: 5 minutes
Six minute walk test
Time frame: 10 minutes
MMRC Dyspnea Scale
Time frame: 5 minutes
SGRQ Questionnaire
Time frame: 20 minutes
HAD Questionnaire
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 17 Aug 2017.
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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?
An observational study of COPD, run by Izmir Katip Celebi University.
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 0 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 17 Aug 2017. 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?
Respiratory Function Test (time frame: 15 minutes). 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 17 Aug 2017.