Pulmonary Rehabilitation and Quality of Life

• Sponsor: Afyonkarahisar Health Sciences University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04214275
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.9
• Patients Per Site Per Month: 3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass Graft	Other: pulmonary rehabilitation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Pulmonary Rehabilitation on Respiratory Functions and Quality of Life Following Coronial Artery Bypass Grafting: a Randomized Controlled Trial
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Dec 29, 2017
• Actual Study Completion Date: Dec 29, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The Pulmonary Function Test (PFT) [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.

2. The Pulmonary Function Test (PFT) Change [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.

Secondary Outcome Measures

1. The Short-Form Health Survey (SF-36) [preoperative day]

   The points given vary between 0-100; 0 points indicate bad health and 100 points indicate that health is progressing in a good direction.

2. The Short-Form Health Survey (SF-36) Change [postoperative sixth week]

   The points given vary between 0-100; 0 points indicate bad health and 100 points indicate that health is progressing in a good direction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Afyonkarahisar Health Science University	Afyonkarahisar	Centre	Turkey	03200

Sponsors and Collaborators

• Afyonkarahisar Health Sciences University

Investigators

• Principal Investigator: Yeliz Ciğerci, PhD, [phone]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yeliz Ciğerci, Director, Afyonkarahisar Health Sciences University
• ClinicalTrials.gov Identifier: NCT04214275
• Other Study ID Numbers: 2016/806
• First Posted: Jan 2, 2020
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yeliz Ciğerci, Director, Afyonkarahisar Health Sciences University: coronary artery bypass; pulmonary rehabilitation; quality of life; respiratory functions

Study Results

No Results Posted as of Jan 2, 2020