Improvement of restless leg syndrome in maintenance hemodialysis patients with limb ischemic preconditioning: a single-center randomized controlled clinical trial

Abstract

Objective: This study evaluated the efficacy and safety of limb ischemic preconditioning (LIPC) in treating restless leg syndrome (RLS) in maintenance hemodialysis (MHD) patients. Methods: A total number of 45 patients participated in the study. They were randomly divided into LIPC group and control group. The LIPC was performed by inflating the limb ischemic preconditioning training device in the patient’s thigh to 200 mmHg to create transient ischemia, whereas control group inflated the device to 20 mmHg. International Restless Legs Syndrome (IRLS), Clinical Global Impression Scale (CGI-S), and Medical Outputs Study Sleep Scale were employed to evaluate LIPC effectiveness. The primary endpoint was the ‘rate of clinical improvement in RLS severity’, defined as the percentage of patients who had an IRLS score decrease of ≥5 points in each group. Results: After intervention, the rate of clinical improvement in RLS severity was 56.5% in the LIPC group and 13.6% in the control group (13 (56.5) vs 3 (13.6), p = 0.003). In addition, the LIPC group’s IRLS, CGI-S scores, the sleep disturbance and somnolence scores showed a significant downward trend compared to the control group (−5.5 ± 5.3 vs − 1.0 ± 3.8, p = 0.002; −1.7 ± 1.2 vs − 0.5 ± 1.4, p = 0.003; −15.5 ± 17.8 vs 3.7 ± 12.0, p < 0.001; −9.9 ± 18.8 vs − 2.4 ± 8.6, p = 0.003). During the study, there were no serious adverse event in any of the patients. Conclusions: LIPC could be employed to effectively and safely alleviate the RLS symptoms in MHD patients.