Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: 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

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)

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Aortic Dissection Acute Aortic Syndrome Aneurysm Aortic Diseases Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Routine

Behavioral

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.

Discharge & Follow-up: Enforce BP control through medication adherence. Ban vigorous activities (mountaineering/swimming/competitive sports); allow low-stress aerobics . Distribute Exercise Diaries (Appx 6) mandating daily logs with critical warnings: STOP immediately if nausea, chest pressure, dizziness, dyspnea, or arrhythmia occur and urgent revisit. Require complete tobacco cessation and secondhand smoke avoidance.

BCW

Behavioral

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 distance >450m: Prescribe low-intensity aerobic walking " Speed: 3 km/h" Progression: Start at 10 min/day (≈500 steps), increase by 10 min every other day up to 40 min/day 1.4 Intermediate Rehabilitation (Weeks 5-12): Moderate-intensity aerobic walking + Resistance training :▪ Walking: 4-6 km/h, 30 min/session, 3 sessions/week▪ Resistance training: Seated elastic band exercises, 20 min/session, 2 sessions/week

Primary outcomes

  1. SF-36

    Time frame: Preoperative，1 month postoperative，3 month postoperative

Secondary outcomes

  1. HADS

    Time frame: Preoperative，1 month postoperative，3 month postoperative

    Hospital Anxiety and Depression Scale，HADS

  2. PISQ

    Time frame: Preoperative，1 month postoperative，3 month postoperative

    Pittsburgh Sleep Quality Index

  3. Self-Efficacy for Exercise Scale

    Time frame: Preoperative，1 month postoperative，3 month postoperative

    SEE-C

  4. complications

    Time frame: Within 3 months postoperatively

  5. 6MWT

    Time frame: Predischarge ,1 month postoperative，3 month postoperative

Sponsors and collaborators

Lead sponsor

Shuzhen Wang

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.