Coronary Artery Bypass GraftNCT04214275
Pulmonary Rehabilitation and Quality of Life
A study testing pulmonary rehabilitation in people with Coronary Artery Bypass Graft, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of a pulmonary rehabilitation (PR) program on the respiratory function and quality of life of patients undergoing CABG surgery with an open-heart technique is examined. A randomized controlled experimental design was used. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Bypass Graft
- What is being tested?
- pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2016to 29 Dec 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who were extubated in twenty-four hours,
- aged 18 or above,
- had undergone CABG surgery using the open-heart method and using a saphenous vein graft for CABG,
- who were conscious,
- without visual and hearing problems,
- who spoke Turkish,
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- had not orthopedic, psychiatric and neurological problems,
- no co-morbid lung disease,
- who had not been re-operated on,
- had not postoperative cardiac dysfunction,
- had not developed postoperative atrial fibrillation,
- who were willing to participate in the study.
Who cannot join
- Patients who were not extubated in twenty-four hours,
- who were under 18 years of age,
- had not undergone CABG surgery using the open-heart method and using a saphenous vein graft for CABG,
- who were not conscious,
- were visual and hearing problems,
- who don't spoke Turkish,
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- had orthopedic, psychiatric and neurological problems,
- co-morbid lung disease,
- who had been re-operated on,
- had postoperative cardiac dysfunction,
- had developed postoperative atrial fibrillation,
- who were not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar, Centre, 03200
About this study
Official title: The Effect of Pulmonary Rehabilitation on Respiratory Functions and Quality of Life Following Coronial Artery Bypass Grafting: a Randomized Controlled Trial
In this study, the effect of a pulmonary rehabilitation (PR) program on the respiratory function and quality of life of patients undergoing CABG surgery with an open-heart technique is examined. A randomized controlled experimental design was used. The study was conducted with two groups: the intervention group (n=25) and control group (n=25). The control group received standard care after CABG. In contrast, the experimental group, in addition to standard care, participated in a PR program created by the researchers. After CABG, the respiratory functions of both groups (clinical care day 4) and quality of life (6th week) evaluated
- Conditions
- Coronary Artery Bypass Graft
- Being tested
- pulmonary rehabilitation
- Keywords
- coronary artery bypass, pulmonary rehabilitation, quality of life, respiratory functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationOther
Simple breathing techniques, secretion-removal techniques, airway-cleaning techniques, mobilization techniques and use of an incentive spirometer
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | standard care and participated in a pulmonary rehabilitation program Receives: Other: pulmonary rehabilitation |
| control group | No intervention | received standard care after coronary artery bypass graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pulmonary Function Test (PFT)
A diagnostic criterion used to identify patients with or at risk of pulmonary dysfunction. The PFT assessment was performed using the NDD Easy on-PC spirometer. During this test, challenging expiratory volume (FEV1 % (>80)), challenging vital capacity (FVC % (>80)), FEV1/FVC ( %, >80) ratio, and Peak Expiratory air pressure (PEF % (>100)) were measured in the first second. The PFT was performed in the Chest Diseases Outpatient Clinic of the hospital preoperatively.
Measured: Preoperative day
The Pulmonary Function Test (PFT) Change
A diagnostic criterion used to identify patients with or at risk of pulmonary dysfunction. The PFT assessment was performed using the NDD Easy on-PC spirometer. During this test, challenging expiratory volume (FEV1 % (>80)), challenging vital capacity (FVC % (>80)), FEV1/FVC ( %, >80) ratio, and Peak Expiratory air pressure (PEF % (>100)) were measured in the first second. The PFT was performed in the Chest Diseases Outpatient Clinic of the hospital preoperatively. The PFT was performed in the Chest Diseases Outpatient Clinic of the 4th day of clinical care.
Measured: 4th day of clinical care
Secondary outcomes (2)
The Short-Form Health Survey (SF-36)
The points given vary between 0-100; 0 points indicate bad health and 100 points indicate that health is progressing in a good direction.
Measured: preoperative day
The Short-Form Health Survey (SF-36) Change
The points given vary between 0-100; 0 points indicate bad health and 100 points indicate that health is progressing in a good direction.
Measured: postoperative sixth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Aug 2016
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Ciğerci, Afyonkarahisar Health Sciences University
- Investigators
- Yeliz Ciğerci, PhD, Principal investigator, +90 272 444 0304
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214275
- Sponsor's protocol ID
- 2016/806
- Status last verified
- Dec 2019
- First submitted
- 26 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulmonary Rehabilitation on Respiratory Functions and Quality of Life Following Coronial Artery Bypass Grafting: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04214275
- Acronym / sponsor ID
- 2016/806
- Conditions
- Coronary Artery Bypass Graft
- Keywords
- coronary artery bypass, pulmonary rehabilitation, quality of life, respiratory functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 2 Jan 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.
In this study, the effect of a pulmonary rehabilitation (PR) program on the respiratory function and quality of life of patients undergoing CABG surgery with an open-heart technique is examined. A randomized controlled experimental design was used. The study was conducted with two groups: the intervention group (n=25) and control group (n=25). The control group received standard care after CABG. In contrast, the experimental group, in addition to standard care, participated in a PR program created by the researchers. After CABG, the respiratory functions of both groups (clinical care day 4) and quality of life (6th week) evaluated
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: pulmonary rehabilitationstandard care and participated in a pulmonary rehabilitation program |
| control group | No intervention | –received standard care after coronary artery bypass graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who were extubated in twenty-four hours,
- aged 18 or above,
- had undergone CABG surgery using the open-heart method and using a saphenous vein graft for CABG,
- who were conscious,
- without visual and hearing problems,
Key exclusion criteria (12 listed)
- Patients who were not extubated in twenty-four hours,
- who were under 18 years of age,
- had not undergone CABG surgery using the open-heart method and using a saphenous vein graft for CABG,
- who were not conscious,
- were visual and hearing problems,
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 rehabilitationSimple breathing techniques, secretion-removal techniques, airway-cleaning techniques, mobilization techniques and use of an incentive spirometer | Other | intervention group |
Primary outcome
The Pulmonary Function Test (PFT)
Time frame: Preoperative day
A diagnostic criterion used to identify patients with or at risk of pulmonary dysfunction. The PFT assessment was performed using the NDD Easy on-PC spirometer. During this test, challenging expiratory volume (FEV1 % (>80)), challenging vital capacity (FVC % (>80)), FEV1/FVC ( %, >80) ratio, and Peak Expiratory air pressure (PEF % (>100)) were measured in the first second. The PFT was performed in the Chest Diseases Outpatient Clinic of the hospital preoperatively.
The Pulmonary Function Test (PFT) Change
Time frame: 4th day of clinical care
A diagnostic criterion used to identify patients with or at risk of pulmonary dysfunction. The PFT assessment was performed using the NDD Easy on-PC spirometer. During this test, challenging expiratory volume (FEV1 % (>80)), challenging vital capacity (FVC % (>80)), FEV1/FVC ( %, >80) ratio, and Peak Expiratory air pressure (PEF % (>100)) were measured in the first second. The PFT was performed in the Chest Diseases Outpatient Clinic of the hospital preoperatively. The PFT was performed in the Chest Diseases Outpatient Clinic of the 4th day of clinical care.
2 secondary outcomes
The Short-Form Health Survey (SF-36)
Time frame: preoperative day
The Short-Form Health Survey (SF-36) Change
Time frame: postoperative sixth week
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 2 Jan 2020.
- Individual participant dataSharing planned: Yes
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Coronary Artery Bypass Graft (CABG)
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.
Yeliz Ciğerci, PhD principal investigator
+90 272 444 0304
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation in people with Coronary Artery Bypass Graft, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 12 inclusion and 12 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 2 Jan 2020. 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 Turkey (Türkiye). 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?
The Pulmonary Function Test (PFT) (time frame: Preoperative day). 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 2 Jan 2020.