A Phase 2 interventional study of Virtual reality platform on head mounted display in Hemodialysis, sponsored by University of Campania Luigi Vanvitelli. Not yet recruiting at 2 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by University of Campania Luigi Vanvitelli · Phase 2, Interventional, and Treatment
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.
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.
2,030 studies on the registry are indexed under Renal Insufficiency; 168 are open to participants now.
This study's planned enrollment of 60 is above the median of 43 across 1,534 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →University of Campania Luigi Vanvitelli is the lead sponsor of 174 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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
Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions.
Enhance Virtual Reality platform on a Meta Quest head mounted display
Accept the invitation to participate
Proportion of screened patients who participate in one or more sessions of allocated virtual reality training.
Time frame: 4, 12 weeks
Appropriateness of eligibility criteria
Recruitment rate during 12 weeks of recruitment phase.
Time frame: 12 weeks
Retention
Proportion of randomized participants who complete the intervention and complete follow-up at 12 weeks.
Time frame: 12 weeks
Acceptability
Proportion of randomized participants who complete \>80% of the treatments during 12 weeks follow-up.
Time frame: 12 weeks
Proportion of adverse events
Proportion of randomized participants who have adverse event reporting completed at 12 weeks.
Time frame: 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.
Time frame: 0, 4, 12, 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0, 4, 12, 24 weeks
Health utility
Proportion of randomized participants who complete an authors' designed questionnaire
Time frame: 0 and 12 weeks
All-cause death
All-cause death reported during the study
Time frame: 12 weeks
Cardiovascular events
All cardiovascular events (myocardial infarction, stroke, peripheral arterial event) reported during the study
Time frame: 12 weeks
Pulse
Pulse rate (bpm)
Time frame: 0 and 12 weeks
Systolic blood pressure
Systolic blood pressure (mmHg)
Time frame: 0 and 12 weeks
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Time frame: 0 and 12 weeks
Functional near-infrared spectroscopy
Functional near-infrared spectroscopy (fNIR)
Time frame: 0 and 12 weeks
Kt/V
Kt/V
Time frame: 0 and 12 weeks
Dialysis duration
Dialysis duration (min)
Time frame: 0 and 12 weeks
Type of dialysis
Type of dialysis
Time frame: 0 and 12 weeks
Hemoglobin
Hemoglobin (g/dL)
Time frame: 0 and 12 weeks
Glucose
Glucose (mg/dL)
Time frame: 0 and 12 weeks
Glycated hemoglobin
HbA1c (%)
Time frame: 0 and 12 weeks
Serum creatinine
Serum creatinine (mg/dL)
Time frame: 0 and 12 weeks
Serum albumin
Serum albumin (g/dL)
Time frame: 0 and 12 weeks
Plan to share: No — Data will be available after request to the principal investigator.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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