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

Shuzhen Wang

Status: Invitation-only

Conditions: Aortic Dissection

Treatments: Behavioral: BCW; Behavioral: Routine

Study type: Interventional

Funder types: Other

Identifiers

NCT07117500

IIT-I-2025-083

Details and patient eligibility

About

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)

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Conscious and capable of voluntary participation in this study (with documented informed consent).

Exclusion criteria

1. Severe concomitant organ diseases, such as coronary artery disease (CAD) , valvular heart disease , ventricular aneurysm , or life-threatening arrhythmias .
2. Patients with unstable angina or myocardial infarction within the past 1 month .
3. Patients with comorbid psychiatric disorders.
4. Patients with active infections or malignant tumors.
5. Presence of pacemakers or implantable cardioverter-defibrillators (ICDs) .
6. Translation : Hemodynamic instability with thrombosis , malperfusion , or coagulopathies.
7. Concurrent participation in other clinical trials .

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

BCW Rehabilitation

Experimental group

Treatment:

Behavioral: Routine

Behavioral: BCW

Routine Care

Active Comparator group

Treatment:

Behavioral: Routine