Research on the Development and Implementation of an Exercise Rehabilitation Program for Aortic Dissection Patients After Percutaneous Intervention Based on the Behavior Change Wheel Theory
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SF-36
研究概览
简要总结
Study Title ： Effectiveness of a BCW Theory-Based Exercise Rehabilitation Program in Post-Endovascular Aortic Dissection Patients: A Randomized Controlled Trial
Primary Objective ： To determine whether an exercise rehabilitation program constructed based on the Behavior Change Wheel (BCW) framework improves postoperative quality of life (QoL) in patients undergoing endovascular aortic repair (EVAR).
Methodology ： Intervention Group (n= 40): Receives the BCW-based exercise rehabilitation protocol.
Control Group (n= 40): Receives routine care and health education . Outcome Measures ：
Primary Endpoint :QoL changes assessed via validated scales ( SF-36) at:
Pre-discharge (T0)
1 month postoperatively (T1) 3 months postoperatively (T2)
Secondary Endpoints (Daily Monitoring):
Exercise duration (minutes/day) Exercise intensity Post-exercise blood pressure (mmHg) Post-exercise heart rate (bpm)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed aortic dissection diagnosis by CTA and MRI, undergoing endovascular interventions : Thoracic Endovascular Aortic Repair (TEVAR), fenestrated endografting, or branched stent-graft techniques.
- •Conscious and capable of voluntary participation in this study (with documented informed consent).
排除标准
- •Severe concomitant organ diseases, such as coronary artery disease (CAD) , valvular heart disease , ventricular aneurysm , or life-threatening arrhythmias .
- •Patients with unstable angina or myocardial infarction within the past 1 month .
- •Patients with comorbid psychiatric disorders.
- •Patients with active infections or malignant tumors.
- •Presence of pacemakers or implantable cardioverter-defibrillators (ICDs) .
- •Translation : Hemodynamic instability with thrombosis , malperfusion , or coagulopathies.
- •Concurrent participation in other clinical trials .
研究组 & 干预措施
Routine Care
干预措施: Routine (Behavioral)
BCW Rehabilitation
干预措施: Routine (Behavioral)
BCW Rehabilitation
干预措施: BCW (Behavioral)
结局指标
主要结局
SF-36
时间窗: Preoperative，1 month postoperative，3 month postoperative
次要结局
- HADS(Preoperative，1 month postoperative，3 month postoperative)
- PISQ(Preoperative，1 month postoperative，3 month postoperative)
- complications(Within 3 months postoperatively)
- 6MWT(Predischarge ,1 month postoperative，3 month postoperative)
- Self-Efficacy for Exercise Scale(Preoperative，1 month postoperative，3 month postoperative)
研究者
Shuzhen Wang
Nurse Practitioner (NP)
Second Affiliated Hospital of Nanchang University