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Enrolling by invitationNCT07117500Updated Aug 12, 2025

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

An interventional study of Routine and BCW in Aortic Dissection, sponsored by Shuzhen Wang. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by Shuzhen Wang · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Aortic Dissection

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 .
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    BCW Rehabilitation

    Behavioral: Routine · Behavioral: BCW

  • Active comparator
    Routine Care

    Behavioral: Routine

Interventions

  • BehavioralRoutine

    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.

  • BehavioralBCW

    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

05

What researchers measure

Primary outcomes

  1. SF-36

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

Secondary outcomes

  1. HADS

    Hospital Anxiety and Depression Scale,HADS

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

  2. PISQ

    Pittsburgh Sleep Quality Index

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

  3. Self-Efficacy for Exercise Scale

    SEE-C

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

  4. complications

    Time frame: Within 3 months postoperatively

  5. 6MWT

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

06

Study locations

1 site
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330008, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07117500
Lead sponsor
Shuzhen Wang
Responsible party
Shuzhen Wang (Nurse Practitioner (NP), Second Affiliated Hospital of Nanchang University) — Sponsor-investigator
First posted
Aug 12, 2025
Start date
Jul 1, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Aug 12, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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