{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy"
      ],
      "name": "Davide Viggiano"
    },
    {
      "affiliations": [
        "Department of Precision and Regenerative Medicine and Ionian Area (DIMEPRE-J), University of Bari Aldo Moro, Bari, Italy"
      ],
      "name": "Giovanni Pellegrino"
    },
    {
      "affiliations": [
        "Department of Precision and Regenerative Medicine and Ionian Area (DIMEPRE-J), University of Bari Aldo Moro, Bari, Italy",
        "School of Public Health, University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Patrizia Natale"
    },
    {
      "affiliations": [
        "Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy"
      ],
      "name": "Veronica Buonincontri"
    },
    {
      "affiliations": [
        "Nephrology and Dialysis Unit, Eboli Hospital, Eboli, Italy"
      ],
      "name": "Giuseppe Gigliotti"
    },
    {
      "affiliations": [
        "Nephrology and Dialysis Unit, “Vecchio Pellegrini” Hospital, Naples, Italy"
      ],
      "name": "Raffaele Genualdo"
    },
    {
      "affiliations": [
        "Nephrology and Dialysis Unit, “Santa Maria della Pietà” Hospital, Nola, Italy"
      ],
      "name": "Felice Nappi"
    },
    {
      "affiliations": [
        "Department of Advanced Medical and Surgical Sciences, Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy"
      ],
      "name": "Luca De Nicola"
    },
    {
      "affiliations": [
        "Nephrology and Dialysis Unit, “A. Cardarelli” Hospital, Naples, Italy"
      ],
      "name": "Carmela Iodice"
    },
    {
      "affiliations": [
        "Nephrology and Dialysis Unit, “A. Cardarelli” Hospital, Naples, Italy"
      ],
      "name": "Mariarosaria Iannuzzi"
    },
    {
      "affiliations": [
        "Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy",
        "Nephrology and Dialysis Unit, San Felice a Cancello Hospital, San Felice a Cancello, Italy"
      ],
      "name": "Pietro Iulianiello"
    },
    {
      "affiliations": [
        "Nephrology and Dialysis Unit, “San Leonardo” Hospital, Castellamare, Italy"
      ],
      "name": "Maria Rita Auricchio"
    },
    {
      "affiliations": [
        "Nephrology and Dialysis Unit, “San Giuseppe Moscati” Hospital, Avellino, Italy"
      ],
      "name": "Pasquale Zamboli"
    },
    {
      "affiliations": [
        "“Miulli” General Hospital, Division of Nephrology and Dialysis, Department of Medicine and Surgery, LUM Giuseppe Degennaro University, Casamassima, Italy"
      ],
      "name": "Vincenzo Montinaro"
    },
    {
      "affiliations": [
        "Department of Precision and Regenerative Medicine and Ionian Area (DIMEPRE-J), University of Bari Aldo Moro, Bari, Italy",
        "School of Public Health, University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Giovanni Strippoli"
    }
  ],
  "title": "Virtual reality training for cognitive impairment in adults treated with haemodialysis (VIRTUAL): protocol for a multicentre, randomised, open-label feasibility trial",
  "uid": "df5f2177-ba5b-5191-86da-f515a3eb8231"
}