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Enrolling by invitation NCT07117500

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

No phase Interventional Aortic Dissection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine, BCW.
Who it may be relevant to
Registry conditions: Aortic Dissection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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)

Interventions

  • Behavioral Routine
    Inpatient Care: Continuously monitor vital signs (BP, HR, SpO₂), neurological status, and limb function; administer prescribed antihypertensives with thorough medication education and efficacy tracking. Strictly prohibit Valsalva maneuvers . Assess pain levels, wounds, and psychological state; deliver scheduled analgesics and emotional counseling to maintain stable mood. Implement lifestyle optimization: 7+hr sleep/night, portion-controlled nutrition, and gradual postoperative mobilization. Dis
  • Behavioral BCW
    1.1 Assessment of physical fitness and formulation of individualized exercise rehabilitation plans 1.2 Inpatient Phase (Postoperative Day 1 - Week 1): Monitor via ICU Mobility Scale (IMS) before each session:▪ Score 0 : Passive range of motion (PROM) exercises▪ Scores 1-3 : Active bed-based joint mobility training▪ Scores 4-6 : Standing balance training▪ Scores 7-10 : Ambulatory walking training 1.3 Early Outpatient Phase (Weeks 2-4): Initiate when IMS=10:▪ Perform 6-Minute Walk Test (6MWT) ▪ If

Primary outcome measures

  • SF-36 [Time frame: Preoperative，1 month postoperative，3 month postoperative]
Secondary outcome measures (5)
  • HADS [Time frame: Preoperative，1 month postoperative，3 month postoperative]
  • PISQ [Time frame: Preoperative，1 month postoperative，3 month postoperative]
  • Self-Efficacy for Exercise Scale [Time frame: Preoperative，1 month postoperative，3 month postoperative]
  • complications [Time frame: Within 3 months postoperatively]
  • 6MWT [Time frame: Predischarge ,1 month postoperative，3 month postoperative]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • The Second Affiliated Hospital of Nanchang University — Nanchang

Identifiers

NCT: NCT07117500 · IIT-I-2025-083

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗