Effect of a Multicomponent Intervention on Pre-Frailty Status Changes in Patients Undergoing Maintenance Hemodialysis: A Randomized Controlled Study

<b>Aims/Background</b> Pre-frailty is common in patients undergoing maintenance hemodialysis (MHD). Without proper management, it can quickly worsen and progress into frailty, leading to various adverse clinical outcomes. Therefore, timely interventions for pre-frail MHD patients are crucial. However, the response of pre-frail MHD patients to such interventions is currently unclear. This study evaluated the effect of a multicomponent intervention on changes in pre-frailty status, risk factors for frailty, quality of life, and clinical outcomes in pre-frail patients undergoing MHD. <b>Methods</b> Sixty MHD patients were randomly assigned to intervention (received a 12-week multicomponent intervention) and control (received standard care) groups, with 30 participants per group, between February and May 2018. Data were collected at baseline and at 3 and 9 months thereafter. Analyzed outcomes included changes in pre-frailty status, frailty risk factors (such as albumin level, pain, and anxiety), quality of life, and clinical outcomes during the follow-up period. <b>Results</b> Data from a total of 58 MHD patients were collected at three time points. At week 12, frailty scores were 0.9 points lower in the intervention group compared to the control group (<i>p</i> = 0.007). The intervention group showed a 26.2% higher proportion of patients who improved from pre-frailty to non-frailty compared to the control group (<i>p</i> = 0.029), and a 25.9% lower proportion of patients who progressed from pre-frailty to frailty (<i>p</i> = 0.021). Additionally, improvements in albumin levels, pain, anxiety, and quality of life were more significant in the intervention group (all <i>p</i> < 0.05). Although there were fewer incidents of falls and rehospitalizations in the intervention group during follow-up, these differences did not reach statistical significance (all <i>p</i> > 0.05). <b>Conclusion</b> This study validates the effectiveness and practicality of a multicomponent intervention in improving pre-frailty status, frailty risk factors, and quality of life in patients undergoing MHD. <b>Clinical Trial Registration</b> Chinese Clinical Trial Registry (ChiCTR-IOR-17012176).