Multimodality magnetic resonance evaluating the effect of enhanced physical exercise on the growth rate, flow haemodynamics, aneurysm wall and ventricular-aortic coupling of patients with small abdominal aortic aneurysms (AAA MOVE trial): a study protocol for an open-label randomised controlled trial.
rct · Level II
Where this comes from
- Record sourced from PubMed, PMID 38355193.
- Also identified by DOI 10.1136/bmjopen-2023-080073 and PMC identifier 10868247.
- Licence recorded as CC BY-NC.
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Abstract
The best lifestyle for small abdominal aortic aneurysms (sAAA) is essential for its conservative management. Physical exercise can improve the cardiopulmonary function of the patients, but it remains unclear which specific type of exercise is most beneficial for individuals with sAAA. The current study was designed to investigate the effect of physician-guided enhanced physical exercise programme on the aorto-cardiac haemodynamic environment, aneurysm sac wall, cardiac function and growth rate of sAAA by multimodality MRI. AAA MOVE study is a prospective, parallel, equivalence, randomised controlled trial. Eligible individuals will be recruited if they are diagnosed with sAAA (focal dilation of abdominal aorta with maximum diameter <5 cm), without contraindication for MRI scanning, or severe heart failure, or uncontrolled arrhythmia. Participants will be randomly allocated to intervention group (physician-guided enhanced physical exercise programme: mainly aerobic training) and control group (standard clinical care) separately in a 1:1 ratio. The primary outcome is 12-month growth rate of sAAA. The first set of secondary outcomes involve multimodality MRI parameters covering flow haemodynamics, aortic wall inflammation and cardiac function. The other secondary outcome (safety end point) is a composite of exercise-related injury, aneurysm rupture and aneurysm intervention. Follow-up will be conducted at 6 and 12 months after intervention. This study was approved by the Ethics Committee on Biomedical Research of West China Hospital (approval number: 2023-783) on 16 June 2023. Main findings from the trial will be disseminated through presentations at conferences, peer-reviewed publications and directly pushed to smartphone of participants. ChiCTR2300073334.
Medical subject headings
- Aortic Aneurysm, Abdominal