Safety of Venous Thromboembolism Prophylaxis Protocol Using a Novel Leg Exercise Apparatus in Bedridden Patients due to Spinal Diseases

Purpose: Venous thromboembolism (VTE) is a complication in patients with a spinal disease requiring bedfast for conservative therapies. We previously developed a novel leg exercise apparatus (LEX) to encourage patients to exercise their lower extremities during bed rest. The purpose of this study was to evaluate the feasibility and safety of the LEX for the prevention of VTE in patients on bed rest due to spinal disease. Methods: Patients with spinal diseases requiring bed rest were included in the study. Exercise using the LEX was performed for ≥5 minutes. The exercises were performed three or more times per day during the bed rest period. In addition, we evaluated adverse events, such as symptomatic VTE and changes in vital signs, using venous ultrasonography, blood tests, and measurement of vital signs. Results: In total, 31 patients were enrolled (11 men, 20 women), with mean age, height, weight, and body mass index of 72.4 years, 155.2 cm, 55.0 kg, and 22.6 kg/m(2), respectively. Twenty-four subjects had spinal fractures. Twenty-nine patients continued exercising until they could leave their beds. No symptomatic VTE was observed in any patient, and no other severe adverse events were observed. There were no significant changes in vital signs. The average number of exercise days with LEX and length of hospitalization were 11 and 31 days, respectively. Conclusions: This is the first study regarding mechanical thromboprophylaxis through in-bed exercise for patients with bedridden spinal disease. The LEX exercise protocol, in addition to mechanical prophylaxis with graduated compression stockings and intermittent pneumatic compression devices, for the prevention of symptomatic VTE may be feasible and safe for patients with bedridden spinal disease.