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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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07117500
Enrollment
80
Registered
2025-08-12
Start date
2025-07-01
Completion date
2026-02-28
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection

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)

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

Sponsors

Shuzhen Wang
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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 .

Design outcomes

Primary

MeasureTime frame
SF-36Preoperative,1 month postoperative,3 month postoperative

Secondary

MeasureTime frameDescription
HADSPreoperative,1 month postoperative,3 month postoperativeHospital Anxiety and Depression Scale,HADS
PISQPreoperative,1 month postoperative,3 month postoperativePittsburgh Sleep Quality Index
Self-Efficacy for Exercise ScalePreoperative,1 month postoperative,3 month postoperativeSEE-C
complicationsWithin 3 months postoperatively
6MWTPredischarge ,1 month postoperative,3 month postoperative

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026