Safety and Efficacy of Exercise in Type-B Aortic Dissection
Safety and Efficacy of Cardiac Rehabilitation With Exercise in Patients With Type-B Aortic Dissection and Intervention: Pilot Study
Guangdong Provincial People's Hospital
20 participants
May 6, 2025
INTERVENTIONAL
Conditions
Summary
This is a pilot study. The goal of this clinical trial is to evaluate the safety and efficacy of exercise-based cardiac rehabilitation in patients with Type-B Aortic dissection or intramural hematoma or penetrating ulcer and received endovascular repair. The main questions it aims to answer are: • Is exercise-based cardiac rehabilitation safe among these patients? Participants will be randomly assigned to receive usual care plus exercise-based cardiac rehabilitation (guided exercise for 3 months in rehabilitation center) or usual care.
Eligibility
Inclusion Criteria3
- Patients with a previous diagnosis of type B aortic dissection or intramural hematoma or penetrating ulcer, who underwent endovascular aortic repair (EVAR) or EVAR + supra-aortic shunt surgery for more than 1 month, and no related complications (such as endoleak, stent thrombosis, dissection progression, etc.) were found in the postoperative aortic CTA;
- Able to independently carry out basic daily life activities, participants must be able to complete the baseline assessment and start the designated treatment;
- Patients voluntarily participate in this study, sign the written informed consent, and are willing to cooperate with the follow-up;
Exclusion Criteria13
- Acute myocardial infarction occurred 1 month ago;
- Combined with severe aortic stenosis or regurgitation;
- Combined with ascending aortic aneurysm or dissection;
- Acute heart failure occurred 2 weeks ago;
- Combined with severe hypertrophic obstructive cardiomyopathy;
- Chronic renal failure stage 5, which is defined as glomerular filtration rate \<15ml/(min·1.73m2) or dialysis;
- During the screening examination, the patient's alanine aminotransferase or aspartate aminotransferase is greater than or equal to 5 times the upper limit of the normal value specified by our center;
- Patients with any medical history that may affect compliance with the program;
- Patients with severe language, mental or physical disabilities who are unable to participate in the program;
- Pregnant or lactating women, or those with fertility who are unwilling/unable to take effective contraceptive measures;
- Patients participating in other interventional clinical trials;
- Patients with long-term high-intensity exercise habits;
- Patients who are judged by the researchers to be unsuitable for participation in this study;
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Interventions
Participated will receive 36 individualized Exercise-based Cardiac Rehabilitation after enrollment in our Cardiac Rehabilitation Center.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07009067