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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCW Rehabilitation | Experimental |
| |
| Routine Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 | Preoperative,1 month postoperative,3 month postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| HADS | Hospital Anxiety and Depression Scale,HADS | Preoperative,1 month postoperative,3 month postoperative |
| PISQ | Pittsburgh Sleep Quality Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330008 | China |
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| 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 |
|
| Preoperative,1 month postoperative,3 month postoperative |
| Self-Efficacy for Exercise Scale | SEE-C | Preoperative,1 month postoperative,3 month postoperative |
| complications | Within 3 months postoperatively |
| 6MWT | Predischarge ,1 month postoperative,3 month postoperative |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
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