Actively Recruiting
Safety and Efficacy of Cardiac Rehabilitation With Exercise in Patients With Type-B Aortic Dissection and Intervention: Pilot Study
Led by Guangdong Provincial People's Hospital · Updated on 2025-06-06
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of exercise-based cardiac rehabilitation in patients with Type-B aortic dissection, intramural hematoma, or penetrating ulcer who have undergone endovascular repair. This pilot clinical trial aims to determine if guided exercise is safe and beneficial for these patients compared to usual care alone. Participants will be randomly assigned to one of two groups to explore these questions. One group will receive usual care plus exercise-based cardiac rehabilitation, involving 36 personalized exercise sessions conducted over 3 months at a cardiac rehabilitation center. The other group will receive usual care without additional exercise intervention. The study includes a 3-month period during which the rehabilitation and monitoring take place, focusing on assessing safety and heart health. Participants will undergo evaluations including monitoring for adverse events during exercise, measurement of aortic diameter, assessment of dissection progression, and checking for endoleaks at the 3-month mark. Researchers will track these outcomes to assess the impact of the rehabilitation program. The study runs until December 2028, with patients aged 18 to 75 years involved, and includes follow-up to ensure safety and adherence throughout the trial period.
CONDITIONS
Brief Title
Safety and Efficacy of Exercise in Type-B Aortic Dissection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with type B aortic dissection, intramural hematoma, or penetrating ulcer who had endovascular aortic repair or EVAR plus supra-aortic shunt surgery more than 1 month ago without complications seen on postoperative aortic CTA
- Able to independently carry out basic daily life activities and complete baseline assessment
- Willing to voluntarily participate in the study, sign informed consent, and cooperate with follow-up
You will not qualify if you...
- Acute myocardial infarction within the past 1 month
- Severe aortic stenosis or regurgitation
- Ascending aortic aneurysm or dissection
- Acute heart failure within the past 2 weeks
- Severe hypertrophic obstructive cardiomyopathy
- Chronic renal failure stage 5 or dialysis
- Alanine aminotransferase or aspartate aminotransferase levels 5 times or more above normal
- Medical history affecting program compliance
- Severe language, mental, or physical disabilities preventing participation
- Pregnant or lactating women or those unwilling or unable to use contraception
- Participation in other interventional clinical trials
- Long-term high-intensity exercise habits
- Judged unsuitable for participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 sessions
Participants in the rehabilitation group receive individualized exercise-based cardiac rehabilitation sessions.
36 rehabilitation sessions
Duration - 3 months
Participants are monitored for adverse events and changes in aortic condition after completing rehabilitation or control period.
Assessments at 3 months
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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