Safety and Efficacy of Exercise in Type-B Aortic Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise-based Cardiac Rehabilitation.
- Who it may be relevant to
- Registry conditions: Type B Aortic Dissection. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Cardiac Rehabilitation With Exercise in Patients With Type-B Aortic Dissection and Intervention: Pilot Study
Overview
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.
Interventions
- Behavioral Exercise-based Cardiac Rehabilitation
Participated will receive 36 individualized Exercise-based Cardiac Rehabilitation after enrollment in our Cardiac Rehabilitation Center.
Primary outcome measures
- Adverse events during exercise [Time frame: 3 months]
- Aortic diameter [Time frame: 3 months]
- Progression of dissection [Time frame: 3 months]
- Endoleak [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT07009067 · KY2025-203