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| ID | Type | Description | Link |
|---|---|---|---|
| PRIN20225JEHW8 | Other Grant/Funding Number | PRIN 2022 |
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| Name | Class |
|---|---|
| University of Sydney | OTHER |
| University of Bari Aldo Moro | OTHER |
| University of Otago | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Active Comparator | Participants will use the virtual reality during the standard dialysis session for 30 minutes, three times a week for 12 weeks. |
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| Standard care | No Intervention | Participants will perform the standard dialysis session three times a week for 12 weeks without virtual reality training sessions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality platform on head mounted display | Device | Enhance Virtual Reality platform on a Meta Quest head mounted display |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bari | Bari | BA | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42366016 | Derived | Viggiano D, Pellegrino G, Natale P, Buonincontri V, Gigliotti G, Genualdo R, Nappi F, De Nicola L, Iodice C, Iannuzzi M, Iulianiello P, Auricchio MR, Zamboli P, Montinaro V, Strippoli G. Virtual reality training for cognitive impairment in adults treated with haemodialysis (VIRTUAL): protocol for a multicentre, randomised, open-label feasibility trial. BMJ Open. 2026 Jun 28;16(6):e120700. doi: 10.1136/bmjopen-2026-120700. |
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Data will be available after request to the principal investigator.
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| Univerity Vanvitelli | Naples | 80133 | Italy |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |