NCT Number: NCT07725887
Coronary artery bypass grafting (CABG) may be associated with prolonged recovery, particularly in high-risk patients. Although preoperative rehabilitation has shown promising results, evidence remains limited because of heterogeneous intervention protocols and variations in postoperative care. This study aims to investigate the effects of a structured inpatient physiotherapy program initiated at least two days before surgery and continued postoperatively, compared with the same structured physiotherapy program provided only during the postoperative period, in high-risk CABG patients. The primary outcome is hospital length of stay. Secondary outcomes include intensive care unit length of stay, C-reactive protein, neutrophil-to-lymphocyte ratio, hemoglobin, dyspnea, and fatigue.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Istanbul, Eyupsultan, Turkey (Türkiye)
Location status: Recruiting
Ayşe Sena Manzak Dursun, PT, PhD
CONTACT
Ayşe Sena Manzak Dursun, PT, PhD
PRINCIPAL_INVESTIGATOR
Fuat Gokdemir, PT, MSc
CONTACT
Fuat Gokdemir, PT, MSc
PRINCIPAL_INVESTIGATOR
Coronary artery bypass grafting (CABG) is commonly performed for the treatment of coronary artery disease. Postoperative recovery may be prolonged in patients with advanced age, reduced left ventricular ejection fraction, multivessel coronary artery disease, smoking history, and multiple comorbidities.
Preoperative rehabilitation has been proposed as a strategy to support postoperative recovery. However, previous studies have used heterogeneous intervention protocols and different postoperative care approaches.
This study will compare two physiotherapy strategies in high-risk CABG patients. Participants in the intervention group will receive a structured inpatient physiotherapy program initiated at least two days before surgery and continued postoperatively. The program includes breathing exercises, incentive spirometry, bronchial hygiene techniques, progressive early mobilization, and postural exercises. Before surgery, one supervised session will be provided daily, and participants will be instructed to repeat the program independently twice daily.
Participants in the control group will receive the same structured physiotherapy program only during the postoperative period.
The primary outcome is hospital length of stay. Secondary outcomes include intensive care unit length of stay, hemoglobin, C-reactive protein, neutrophil-to-lymphocyte ratio, dyspnea, and fatigue.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Left ventricular ejection fraction (LVEF) <40%. Three-vessel coronary artery disease. More than two comorbidities. History of smoking. Age >65 years.
Exclusion criteria
Participants will receive a structured inpatient physiotherapy program initiated at least two days before CABG surgery and continued throughout postoperative hospitalization. The program includes breathing exercises, incentive spirometry, bronchial hygiene techniques, progressive early mobilization, and postural exercises. Before surgery, one supervised session will be provided daily, and participants will be instructed to repeat the program independently twice daily.
Participants will receive the same structured inpatient physiotherapy program only during the postoperative hospitalization. The program includes breathing exercises, incentive spirometry, bronchial hygiene techniques, progressive early mobilization, and postural exercises.
Time frame: From surgery until hospital discharge (approximately 7-14 days)
Postoperative hospital length of stay, defined as the number of days from surgery until hospital discharge.
Time frame: From surgery until discharge from the intensive care unit (approximately 1-5 days)
Length of stay in the intensive care unit, measured in days from admission to discharge from the intensive care unit.
Time frame: Baseline (preoperative), through hospital discharge (up to approximately 30 days after surgery), and 7-10 days after hospital discharge.
Hemoglobin concentration measured as part of routine clinical laboratory testing and expressed in grams per deciliter (g/dL).
Time frame: Baseline (preoperative), through hospital discharge (up to approximately 30 days after surgery), and 7-10 days after hospital discharge.
Serum C-reactive protein concentration measured as part of routine clinical laboratory testing and expressed in milligrams per liter (mg/L) to assess postoperative inflammatory response.
Time frame: Baseline (preoperative), through hospital discharge (up to approximately 30 days after surgery), and 7-10 days after hospital discharge.
Neutrophil-to-lymphocyte ratio calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. The NLR is a unitless index used to assess systemic inflammatory response.
Time frame: At the first postoperative physiotherapy session on the surgical ward and at the final physiotherapy session before hospital discharge.
Dyspnea assessed using the Modified Borg Dyspnea Scale (0-10), with higher scores indicating greater perceived breathlessness.
Time frame: At the first postoperative physiotherapy session on the surgical ward and at the final physiotherapy session before hospital discharge.
Fatigue assessed using the Modified Borg Fatigue Scale (0-10), with higher scores indicating greater perceived fatigue.
Contact information is provided by the study sponsor or research team.
Ayşe Sena Manzak Dursun, PT, PhD
CONTACT
Fuat Gökdemir, PT, MSc
CONTACT
Bezmialem Vakif University
Other
Effect of a Preoperatively Initiated Structured Inpatient Physiotherapy Program on Postoperative Outcomes in High-Risk Coronary Artery Bypass Grafting Patients
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