Physical Activity, Bleedings and Quality of Life in Patients with Haemophilia a without Inhibitors - a Multicenter, Observational Italian Study with a Wearable Device

Introduction: Haemophilia A (HA) is characterized by spontaneous or traumatic recurrent bleedings, especially in joints and muscles, which can cause haemophilic arthropathy, impaired function, and in turn, reduce physical and social activities and negatively impact the quality of life (Franchini M at al., Semin Thromb Hemost, 2022 Nov; Mannucci PM et al., N Engl J Med, 2001 Jun). Despite regular physical activity (PA) being strongly recommended by guidelines as a key element to improve well-being and mental health, the perception of an associated increased risk of bleeding and bleed-related issues discourage people with hemophilia A (PWHA) (Makris M at al, Haemophilia, 2013 Jan; Matlary RED at al., Haemophilia, 2022 Nov; Srivastava A et al., Haemophilia, 2020 Aug 1) Methods: This cohort study (NCT04165135 - POWER) is a multicenter study conducted in 18 investigational Italian sites aimed at gathering data on activity status, bleeding, QoL, and health status, through the use of a wearable device and an ePRO app, in individuals with moderate or severe HA without inhibitors receiving standard of care (SoC) treatment. This population was observed for 12 months or up to 18 months if the therapy with a newly approved product was initiated during the study. The study started in January 2020 and has been completed in April 2022 with the last data collection. Results: A total of 103 male patients represented the Intention To Treat Population (ITT). Of them, 97 (94.2%) had severe (FVIII