Aortic DissectionNCT07117500
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
A study testing Routine and BCW in people with Aortic Dissection, run by Shuzhen Wang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Routine and BCW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
About this study
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).
Read more
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
- Being tested
- Routine, BCW
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoutineBehavioural
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.
BCWBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| BCW Rehabilitation | Experimental | Not described Receives: Behavioral: Routine; Behavioral: BCW |
| Routine Care | Active comparator | Not described Receives: Behavioral: Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36
Measured: Preoperative，1 month postoperative，3 month postoperative
Secondary outcomes (5)
HADS
Hospital Anxiety and Depression Scale，HADS
Measured: Preoperative，1 month postoperative，3 month postoperative
PISQ
Pittsburgh Sleep Quality Index
Measured: Preoperative，1 month postoperative，3 month postoperative
Self-Efficacy for Exercise Scale
SEE-C
Measured: Preoperative，1 month postoperative，3 month postoperative
complications
Measured: Within 3 months postoperatively
6MWT
Measured: Predischarge ,1 month postoperative，3 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuzhen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuzhen Wang, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117500
- Sponsor's protocol ID
- IIT-I-2025-083
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07117500
- Acronym / sponsor ID
- IIT-I-2025-083
- Conditions
- Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shuzhen WangUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCW Rehabilitation | Experimental | Behavioral: Routine, Behavioral: BCW |
| Routine Care | Active comparator | Behavioral: Routine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoutineInpatient 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. | Behavioural | BCW Rehabilitation, Routine Care |
| BCW1.1 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 | Behavioural | BCW Rehabilitation |
Primary outcome
SF-36
Time frame: Preoperative，1 month postoperative，3 month postoperative
5 secondary outcomes
HADS
Time frame: Preoperative，1 month postoperative，3 month postoperative
PISQ
Time frame: Preoperative，1 month postoperative，3 month postoperative
Self-Efficacy for Exercise Scale
Time frame: Preoperative，1 month postoperative，3 month postoperative
complications
Time frame: Within 3 months postoperatively
6MWT
Time frame: Predischarge ,1 month postoperative，3 month postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine and BCW in people with Aortic Dissection, run by Shuzhen Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 (time frame: Preoperative，1 month postoperative，3 month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.