A Multicenter Randomized Controlled Trial of Exercise in Aortic Dissection Survivors

There are currently no evidence-based guidelines for exercise after thoracic aortic dissection (TAD), leading to highly variable recommendations that frequently lead patients to restrict their physical activities. This multicenter randomized controlled trial was intended to evaluate the safety and efficacy of a moderate intensity guided exercise program for TAD survivors. Participants were eligible for the trial if they had a Type A or Type B dissection at least 90 days before enrollment and could attend two in-person study visits. The guided exercise circuit consisted of six aerobic, isotonic, or isometric exercises that participants continued at home with virtual follow up sessions. The primary endpoint is the change in the composite anxiety and depression PROMIS-29 T-score at 12 months. Secondary endpoints include changes in grip strength, weight, 24-hr ambulatory blood pressure, and arterial biomechanical properties measured by central arterial waveform analysis. Preliminary analysis of the first 81 enrolled participants demonstrated that the guided exercise circuit was completed safely and was not associated with severe exertional hypertension, injury, or adverse cardiovascular events. At enrollment, most participants had adverse central waveform or ABPM characteristics that are associated with increased cardiovascular mortality, such as increased arterial stiffness, nocturnal hypertension, elevated pulse pressure, or blunted nocturnal dipping. Follow up of enrolled participants with longitudinal hemodynamic data to evaluate the impact of the exercise program will conclude in October 2024. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05610462 ### Funding Statement This work was supported in part by a grant from the John Ritter Foundation for Aortic Health and a gift from Carmen David. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study protocol was reviewed and approved by the Committee for the Protection of Human Subjects at the University of Texas Health Science Center at Houston (UTHealth Houston), and institutional review boards at the University of Michigan and Washington University School of Medicine in St. Louis. All subjects signed a written informed consent document prior to enrollment. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript or supplementary information.