Virtual Reality for Cognitive Impairment in Hemodialysis (VIRTUAL)

Virtual Reality Training for Cognitive Impairment in Adults Treated With Hemodialysis: A Feasibility Randomized Controlled Trial

The goal of this randomized feasibility clinical trial is to identify participant recruitment and retention, acceptability, and adherence to virtual reality training in people undergoing hemodialysis. The main question it aims to answer is if virtual reality could be a feasible and acceptable intervention in this setting.

The investigators will compare participants on virtual reality training during the standard dialysis session with those treated with standard dialysis session alone to see if a cognitive training using immersive virtual reality in people on hemodialysis is feasible and acceptable.

Participants randomised in the intervention group will use virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks. The virtual reality intervention will consist of computerized cognitive training of 4 games. Each exercise delivered to the participant will specifically provide training in a specific cognitive category (memory, cognitive flexibility, processing, attention, and memory). Participants randomised in the control group will perform the standard hemodialysis session three times a week for 12 weeks, without using virtual reality.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis
• Intervention / Treatment: Device: Virtual reality platform on head mounted display

Detailed Description

The trial is a multicenter, parallel group, feasibility randomized controlled trial.

The trial population will include adult participants, who have the physical and cognitive capacity to be trained using immersive virtual reality and who have kidney failure on hemodialysis.

Participants will be allocated in the intervention (virtual reality session) or standard of care without the intervention. Participants will be allocated to intervention or standard care by randomization 1:1.

The virtual reality intervention will consist of computerized cognitive training of a subset of 4 short, gamified exercises. The intervention will be accessed through the Enhance VR platform on a Meta Quest 3S head mounted display, Snapdragon XR2 Gen2, processor, 8 Gb RAM, 128 Gb internal memory, resolution per eye in pixels: 1832 x 1920 with a refresh rate of 90-120 Hz and motion controllers. The clinician responsible for the intervention will be in the room with the participant, providing support for the intervention and any technical issues.

The chosen trial duration of 12 weeks is designed to provide exposure to a meaningful dose of cognitive training (three times a week) aligned to previous similar studies and to maximize participant tolerability to immersive virtual reality training.

The endpoints described in this protocol align with the recommendations of the CONSORT 2010 statement: extension to randomized pilot and feasibility studies. The endpoints are specifically chosen to relate to feasibility. The outcomes also include the primary and secondary outcomes for the future definitive randomized controlled trial to assess response, feasibility of measurement, and completeness.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80133
    • Univerity Vanvitelli
    • Contact: Davide Viggiano, Prof; Phone Number: 0815664282; Email: davide.viggiano@unicampania.it
  • BA
    • Bari, BA, Italy, 70124
      • University of Bari
      • Contact: Giovanni Strippoli, Prof; Phone Number: 0805591111; Email: giovanni.strippoli@uniba.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult participants aged 18 years or older and less than or equal to 75 years of age
• Receiving haemodialysis treatment for kidney failure for at least 90 days (permanent reduction in kidney function below an estimated glomerular filtration rate of 15 mL/minute per 1.73 m2)
• Able to provide written and informed consent
• Able to use the immersive virtual reality headset and follow instructions with sufficient motor, visual and auditory function to interact with the intervention
• Able to speak and understand Italian language

Exclusion Criteria:

• Severe cognitive impairment or psychiatric diseases leading to inability to follow instructions and use the virtual reality headset
• Significant nystagmus and/or vertigo leading to inability to tolerate the virtual reality headset
• Insufficient motor function to use the virtual reality system
• Hearing or visual disability
• Advanced or uncompensated chronic diseases unrelated to kidney failure (e.g. advanced cancer, heart failure, lung diseases with poor oxygen saturation)
• Other neurological diseases (ictus, Alzheimer's or other forms of dementia)
• Persistent pain or itch or who using opioids that may interfere with the tests or any other condition that the clinician may judge as influencing the results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Virtual reality; Participants will use the virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks.	Device: Virtual reality platform on head mounted display; Enhance Virtual Reality platform on a Meta Quest head mounted display
No Intervention: Standard care; Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accept the invitation to participate	Proportion of screened patients who participate in one or more sessions of allocated virtual reality training.	4, 12 weeks
Appropriateness of eligibility criteria	Recruitment rate during 12 weeks of recruitment phase.	12 weeks
Retention	Proportion of randomized participants who complete the intervention and complete follow-up at 12 weeks.	12 weeks
Acceptability	Proportion of randomized participants who complete >80% of the treatments during 12 weeks follow-up.	12 weeks
Proportion of adverse events	Proportion of randomized participants who have adverse event reporting completed at 12 weeks.	12 weeks
Quality of life	Proportion of randomized participants who complete the outcome measurements using the Kidney Disease Quality of Life Short Form 36 (KDQOL-36). The KDQOL-36 has five scales, including two generic health related quality of life scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each of the KDQOL-36 kidney-targeted scales are scored by transforming all items linearly to a 0-100 possible range and averaging the items in the scale. On the KDQOL-36, higher scores indicate better health realated quality of life.	0, 4, 12, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Proportion of randomized participants who complete the outcome measurements using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided in two seven-item subscales. The total score for each subscale ranges from 0 to 21. In general a score ≤7 corresponds to "no depression or anxiety," a score of 8-10 is a minor depression/anxiety, a score of 11-15 a moderate depression/anxiety and a score ≥16 is defined as severe depression/anxiety.	0, 4, 12, 24 weeks
Anxiety	Proportion of randomized participants who complete the outcome measurements using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided in two seven-item subscales. The total score for each subscale ranges from 0 to 21. In general a score ≤7 corresponds to "no depression or anxiety," a score of 8-10 is a minor depression/anxiety, a score of 11-15 a moderate depression/anxiety and a score ≥16 is defined as severe depression/anxiety.	0, 4, 12, 24 weeks
Quality of life	Proportion of randomized participants who complete the outcome measurements using the 5-level EQ-5D version (EQ-5D-5L). In the EQ-5D-5L scores range from 0 to 100, where 100 is the best possible health related quality of life.	0, 4, 12, 24 weeks
Fatigue	Proportion of randomized participants who complete the outcome measurements using the Kidney Disease Quality of Life Short Form 36 (KDQOL-36). The KDQOL-36 has five scales, including two generic health related quality of life scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each of the KDQOL-36 kidney-targeted scales are scored by transforming all items linearly to a 0-100 possible range and averaging the items in the scale. On the KDQOL-36, higher scores indicate better outcome.	0, 4, 12, 24 weeks
Health utility	Proportion of randomized participants who complete an authors' designed questionnaire	0 and 12 weeks
All-cause death	All-cause death reported during the study	12 weeks
Cardiovascular events	All cardiovascular events (myocardial infarction, stroke, peripheral arterial event) reported during the study	12 weeks
Pulse	Pulse rate (bpm)	0 and 12 weeks
Systolic blood pressure	Systolic blood pressure (mmHg)	0 and 12 weeks
Diastolic blood pressure	Diastolic blood pressure (mmHg)	0 and 12 weeks
Functional near-infrared spectroscopy	Functional near-infrared spectroscopy (fNIR)	0 and 12 weeks
Kt/V	Kt/V	0 and 12 weeks
Dialysis duration	Dialysis duration (min)	0 and 12 weeks
Type of dialysis	Type of dialysis	0 and 12 weeks
Hemoglobin	Hemoglobin (g/dL)	0 and 12 weeks
Glucose	Glucose (mg/dL)	0 and 12 weeks
Glycated hemoglobin	HbA1c (%)	0 and 12 weeks
Serum creatinine	Serum creatinine (mg/dL)	0 and 12 weeks
Serum albumin	Serum albumin (g/dL)	0 and 12 weeks

Collaborators and Investigators

• Sponsor: University of Campania Luigi Vanvitelli
• Collaborators: University of Otago; University of Sydney; University of Bari Aldo Moro

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: RCT; virtual reality; hemodialysis; kidney failure
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PRIN20225JEHW8 (Other Grant/Funding Number: PRIN 2022)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available after request to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No