Abstract

Abstract Background Therapeutic interventions in vasovagal syncope (VVS) are centered on lifestyle modifications aimed to counteract the recognized mechanisms that precipitate syncope. In patients with recurrent VVS, supervised training might help reduce the symptomatic burden by increasing adherence to lifestyle modifications. Purpose We aimed to evaluate the effect of an integrated supervised training program versus standard care on syncopal recurrence rate among patients with VVS. Methods This randomized, controlled, 1:1 parallel-design, open-label trial was conducted between November 2019 and February 2021. Eligible patients were those aged between 18 and 70 years with newly-diagnosed medication-naïve VVS who had experienced ≥2 syncopal episodes in the prior year. All participants received education and reassurance about the benign nature of VVS, were advised to increase salt and fluid intake, and practice counter-pressure maneuvers based on 2018 European Society of Cardiology syncope guideline (standard care). Patients were randomized to standard VVS care or the training program. The intervention program consisted of thrice-weekly four-hours-long sessions during the first month after randomization; including tilt training, aerobic exercise (with rowing ergometer, recumbent biking), and standardized counter-pressure maneuvers supervised by a team of physical medicine and rehabilitation specialist and a cardiologist. After the first month, the intervention group were planned to attend a four-hours-long session every three months. The control group were followed by phone calls after the initial visit every three months. The intended follow-up duration was one year and the primary outcome was time to first syncopal episode. Results Out of 332 patients screened, 50 (mean age: 33.5 years; 64% female, figure 1) were equally randomized. Follow-up was completed for all participants. After one year, there was a significant reduction in syncope with supervised training compared to standard care (hazard ratio: 0.28; 95% confidence interval: 0.11 to 0.68; p=0.005, figure 2). Furthermore, frequency of syncope was lower in the supervised training arm versus standard of care (median [interquartile range]: 0 [0–1] versus 1 [0–3]; p=0.017). Conclusions In patients with recurrent VVS, supervised training showed promising results in reducing syncopal recurrence. Future research should focus on similar approaches to alter patients' lifestyle as an effective treatment for VVS. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Tehran University of Medical Sciences Figure 1Figure 2

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