跳至主要内容
临床试验/NCT07725887
NCT07725887招募中不适用

Effect of a Preoperatively Initiated Structured Inpatient Physiotherapy Program on Postoperative Outcomes in High-Risk Coronary Artery Bypass Grafting Patients

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Hospital Length of Stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older.
  • Scheduled to undergo elective coronary artery bypass grafting (CABG).
  • High-risk patients meeting at least three of the following criteria:
  • Left ventricular ejection fraction (LVEF) <40%. Three-vessel coronary artery disease. More than two comorbidities. History of smoking. Age >65 years.
  • - Able and willing to provide written informed consent.

排除标准

  • Planned redo CABG surgery.
  • Severe neurological or orthopedic conditions limiting mobilization.
  • Severe cognitive impairment.
  • Hemodynamic instability.
  • Contraindications to mobilization or exercise.
  • Inability to complete at least two days of the preoperative physiotherapy program.

结局指标

主要结局

Hospital Length of Stay

时间窗: 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.

次要结局

  • Intensive Care Unit Length of Stay(From surgery until discharge from the intensive care unit (approximately 1-5 days))
  • Hemoglobin(Baseline (preoperative), through hospital discharge (up to approximately 30 days after surgery), and 7-10 days after hospital discharge.)
  • C-Reactive Protein (CRP)(Baseline (preoperative), through hospital discharge (up to approximately 30 days after surgery), and 7-10 days after hospital discharge.)
  • Neutrophil-to-Lymphocyte Ratio (NLR)(Baseline (preoperative), through hospital discharge (up to approximately 30 days after surgery), and 7-10 days after hospital discharge.)
  • Dyspnea(At the first postoperative physiotherapy session on the surgical ward and at the final physiotherapy session before hospital discharge.)
  • Fatigue(At the first postoperative physiotherapy session on the surgical ward and at the final physiotherapy session before hospital discharge.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Sena Manzak

Asst. Prof.

Bezmialem Vakif University

研究点 (1)

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