Multicenter randomized controlled trial of exercise in aortic dissection survivors: rationale, design, and initial hemodynamic data

Abstract

Aims: 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.

Methods: Participants were eligible 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-h ambulatory blood pressure, and arterial biomechanical properties measured by central arterial waveform analysis.

Results: Preliminary analysis of the first 81 enrolled participants demonstrated that the guided exercise circuit was completed safely and was not associated with severe hypertension, injury, or adverse cardiovascular events. At enrollment, adverse central waveform or ABPM characteristics were prevalent and were significantly associated with exertional hypertension.

Conclusions: Guided exercise is safe for aortic dissection survivors. Follow-up of enrolled participants will conclude in October 2024.

(clinicaltrials.gov Identifier: NCT05610462)

Keywords

Exercise / thoracic aortic dissection / thoracic aortic aneurysm / heritable thoracic aortic disease / ambulatory blood pressure monitoring / hypertension

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