Pulmonary Rehabilitation and Quality of Life

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Graft
• Intervention / Treatment: Other: pulmonary rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Centre
    • Afyonkarahisar, Centre, Turkey, 03200
      • Afyonkarahisar Health Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; standard care and participated in a pulmonary rehabilitation program	Other: pulmonary rehabilitation; Simple breathing techniques, secretion-removal techniques, airway-cleaning techniques, mobilization techniques and use of an incentive spirometer
No Intervention: control group; received standard care after coronary artery bypass graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University
• Investigators: Principal Investigator: Yeliz Ciğerci, PhD, +90 272 444 0304

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): December 29, 2017

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; pulmonary rehabilitation; coronary artery bypass; respiratory functions
• Other Study ID Numbers: 2016/806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No