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

NCT07117500 | Enrolling By Invitation

• 1 other identifier: IIT-I-2025-083
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• SF-36

  Preoperative，1 month postoperative，3 month postoperative

Secondary Outcomes (5)

• HADS

  Preoperative，1 month postoperative，3 month postoperative

• PISQ

  Preoperative，1 month postoperative，3 month postoperative

• Self-Efficacy for Exercise Scale

  Preoperative，1 month postoperative，3 month postoperative

• complications

  Within 3 months postoperatively

• 6MWT

  Predischarge ,1 month postoperative，3 month postoperative

Study Arms (2)

BCW Rehabilitation

EXPERIMENTAL

Behavioral: Routine; Behavioral: BCW

Routine Care

ACTIVE COMPARATOR

Behavioral: Routine

Interventions

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 Rehabilitation; Routine Care

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

BCW Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Shuzhen Wang: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Practitioner (NP)

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

CN (1)