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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04214275
Other study ID # 2016/806
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date December 29, 2017

Study information

Verified date December 2019
Source Afyonkarahisar University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 29, 2017
Est. primary completion date December 29, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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,

- 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.

Exclusion Criteria:

- 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,

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pulmonary rehabilitation
Simple breathing techniques, secretion-removal techniques, airway-cleaning techniques, mobilization techniques and use of an incentive spirometer

Locations

Country Name City State
Turkey Afyonkarahisar Health Science University Afyonkarahisar Centre

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar University of Health Sciences

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Preoperative day
Primary 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. 4th day of clinical care
Secondary 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. preoperative day
Secondary 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. postoperative sixth week
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