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Completed

NCT Number: NCT04214275

Pulmonary Rehabilitation and Quality of Life

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

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Key information

Conditions

Coronary Artery Bypass Graft

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Science University

Afyonkarahisar, Centre, 03200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary Rehabilitation

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. The Short-Form Health Survey (SF-36)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

The Effect of Pulmonary Rehabilitation on Respiratory Functions and Quality of Life Following Coronial Artery Bypass Grafting: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 2, 2020
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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