Pulmonary Rehabilitation and Quality of Life

NCT04214275 | Completed

• 1 other identifier: 2016/806
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Artery Bypass Graft

Keywords

coronary artery bypass; pulmonary rehabilitation; quality of life; respiratory functions

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• The Short-Form Health Survey (SF-36)

  preoperative day

• The Short-Form Health Survey (SF-36) Change

  postoperative sixth week

Study Arms (2)

intervention group

EXPERIMENTAL

standard care and participated in a pulmonary rehabilitation program

Other: pulmonary rehabilitation

control group

NO INTERVENTION

received standard care after coronary artery bypass graft

Interventions

pulmonary rehabilitation OTHER

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

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, Centre, 03200, Turkey (Türkiye)

Location

Study Officials

• Yeliz Ciğerci, PhD

  +90 272 444 0304

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: January 2, 2020
• Study Start: August 1, 2016
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)