Virtual reality training for cognitive impairment in adults treated with haemodialysis (VIRTUAL): protocol for a multicentre, randomised, open-label feasibility trial

Introduction

Cognitive impairment is prevalent among adults with kidney failure treated with haemodialysis (HD). It affects multiple cognitive domains and contributes to suboptimal quality of life and clinical outcomes. Virtual reality (VR)-based cognitive training has shown benefits in various conditions including older adults without kidney failure; however, its feasibility in people receiving HD is unknown. This trial aims to evaluate the feasibility and acceptability of immersive VR cognitive training in adults undergoing maintenance HD.

Methods and analysis

The VIRTUAL trial is a multicentre, randomised, open-label feasibility study enrolling 60 adult patients (aged 18–75 years) undergoing thrice-weekly high-flux HD or haemodiafiltration for at least 90 days. Participants will be randomly assigned in a 1:1 ratio to receive standard care or standard care plus a 12-week VR cognitive training intervention delivered during dialysis sessions. The intervention consists of gamified tasks targeting memory, attention and processing speed via the Enhance VR platform.

Primary outcomes include recruitment and retention rates, adherence to the intervention, acceptability of trial procedures and quality of life. Secondary outcomes include the completion rates of cognitive and patient-reported assessments and adverse event reporting. Feasibility thresholds will guide recommendations for a future definitive trial.

Results will be disseminated through peer-reviewed publications, presentations at scientific meetings and communication with stakeholders. This feasibility study will inform the design of a future randomised trial evaluating the efficacy of VR-based cognitive training in this population.

Ethics, consent to participate and consent to publish declarations

The study was approved by the Comitato Etico Campania 2 (AOU Università della Campania ‘Luigi Vanvitelli’) following review at the meeting held on 25 July 2024, with formal favourable opinion issued on 31 July 2024 (Protocol: VIRTUAL PRIN20225JEHW8, (protocol number 0020792/i)). The study was conducted in accordance with Good Clinical Practice and applicable regulations. Written informed consent was obtained from all participants prior to enrolment.

Informed consent was obtained from all individual participants included in the study.

Written informed consent was obtained from the patients/participants for publication of their data.

Trial registration number

NCT06739187 .