End Stage Renal DiseaseGoodRENalNCT04823286
Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform
A study testing Virtual reality health platform during hemodialysis in people with End Stage Renal Disease and Hemodialysis-Induced Symptom, run by Cardenal Herrera University at 8 sites in 4 countries.
Trial summary
There is wide evidence regarding the weak points of end-stage Chronic kidney disease (CKD) patients in hemodialysis, and they include three intervention aspects: exercise, nutrition and psychological support. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis-Induced Symptom, Chronic Kidney Diseases
- What is being tested?
- Virtual reality health platform during hemodialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 31 Mar 2021to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on hemodialysis medically stable
- Ability to walk to walk at least a few steps, even if walking aids like canes or a walker ar needed
- Life expectancy greater than 6 months
Who cannot join
- Myocardial infarction in the previous 6 weeks
- Angina unstable on exercise or at rest
- Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia.
- Life expectancy less than 6 months
- Cognitive impairment
- Language barriers
- Illiteracy
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Spain4 sites
Hospital de Manises
Manises, Valencia, 46940
Consorci Sanitari de Terrassa
Terrassa, Barcelona
Universitat de Valencia
Valencia, Valencia, 46010
Universitat Politécnica de Valéncia
Valencia, Valencia, 46022
Sweden2 sites
Skane Univeristy Hospital
Lund
Karolinska Institute
Stockholm, 14186
About this study
Official title: REVID +: Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform (GoodRENal.eu)
There is wide evidence regarding the weak points of end-stage Chronic kidney disease (CKD) patients in hemodialysis, and they include three intervention aspects: exercise, nutrition and psychological support. Evidence shows that exercise for patients in hemodialysis results in increased survival rate, functional capacity, strength and health-related quality of life.
Additionally, different studies have shown the benefits of psychological interventions and the positive effect of educational programs on nutritional care for patients in hemodialysis.
Read more
Despite the well-known benefits of exercise, this kind of programs are not being implemented in the routine clinical care of hemodialysis patients.
Thus, the GoodRENal project aims to promote healthy lifestyles among dialysis patients in a holistic approach that combines exercise, nutrition and psychological wellbeing plus cognitive functioning addressing adult learners. The project will, in phase 1, explore barriers and facilitators of patients, carers and health professionals towards healthy lifestyle (physical activity, nutrition and psychological well being). In phase 2, the project will develop a health virtual platform including these three dimensions of cares. In summary, the project outputs will be:
- A didactic content in a modular platform to create an educational program for integrated treatments in patients with dialysis
- A guideline to promote healthy lifestyles among dialysis patients for health care providers
- A guideline to promote e healthy lifestyles among dialysis patients for patients and formal - nonformal carers
Read the detailed description
CKD stage 5D, has a high incidence, 100-200 people per million, and high prevalence, 750-1500 per million. More than 40-50% are above 65 years old, with a lower rate in women but with higher frailty than men. This cohort presents high comorbidity, malnutrition, sedentary behavior, low health-related quality of life, frailty and high dependency levels. Mortality risk is close to 15% per year. Cardiovascular disease is the main cause of death in end-stage CKD. It is also a high risk factor for peripheral artery disease and lower limbs amputation.
Supporting this cohort results in high direct and indirect costs. Additionally, these patients present high anxiety and depression rates. Comorbidity between depression and somatic illness leads to a significant increase of the illness load since there is higher symptomatology, higher morbidity, higher health costs, and worse functioning and quality of life. Current evidence suggests a bidirectional relationship between depression and medical illness. Mechanisms suggested explaining this complex relationship would include both biological and behavioral aspects. Depression is also associated with the worst adherence to treatment of comorbid patients.
There is wide evidence regarding the weak points of end-stage CKD patients in hemodialysis, and they include three intervention aspects: exercise, nutrition and psychological support. Evidence shows that exercise for patients in hemodialysis results in increased survival rate, functional capacity, strength, and health-related quality of life. Additionally, different studies have shown the benefits of psychological interventions and the positive effect of educational programs on nutritional care for patients in hemodialysis. Several combined interventions have been implemented leading to heterogeneous results.
Despite the well-known benefits of exercise, this kind of programs are not being implemented in the routine clinical care of hemodialysis patients. Patients' lack of interest regarding participation in exercise programs, time constraints, and lack of knowledge by health professionals at the hemodialysis units, are some of the factors underpinning the low implementation rate of intradialysis exercise programs.
Virtual reality (VR) refers to computer-generated interactive simulation that offers users the opportunity to participate in environments that look like objects and events of the real world.
VR exercise has been successfully implemented in neuro-rehabilitation, resulting in better balance, gait, and mobility in cerebrovascular accidents, multiple sclerosis, Guillain-Barre syndrome, and Parkinson's disease. Few studies have explored the impact of VR exercise in renal rehabilitation. Three of the partners (Universidad Cardenal Herrera-CEU, Universitat Politècnica de Valéncia, and Hospital de Manises) have implemented two randomized trials of non-immersive VR exercise intradialysis. Currently, those partners are developing a third trial with this technology and they have verified that this type of exercise has good tolerance and high adherence rates. Additionally, it has a positive impact on strength, functional capacity, physical activity level, and health-related quality of life.
Until now, the most traditional way to assess and implement psychological and psycho-educative treatments has been 'face to face'. Nevertheless, more than 50% of people suffering from depression are not being treated appropriately. This is why alternative treatment models to assess and treat are being implemented, and technology (as the internet) is an option to increase the number of patients that can be treated. Additionally, few studies have explored technology as a means to educate renal patients regarding nutrition or psychological health.
Thus, the hypothesis of the present study is that a health virtual platform designed for holistic treatment of patients undertaking hemodialysis will result in health benefits for this cohort, regarding physical activity, nutritional and psychological health. The platform will be designed according to the aims highlighted by experts, barriers, and needs of end-stage CKD patients and their caregivers. As mentioned above, end-stage chronic kidney disease patients have high comorbidity, malnutrition, sedentarism, low health-related quality of life, low physical function, frailty, and high dependency levels. So they rely on non-formal caregivers for their activities of daily living. This cohort presents high anxiety and depression levels and the combination of somatic disease plus depression results in higher symptoms, higher comorbidity, higher health resources, and worst quality of life. Besides, there is a bidirectional relationship between depression and disease, and depression is associated with lower adherence to medical treatment.
- Being tested
- Virtual reality health platform during hemodialysis
- Keywords
- exercise, physical function, health related quality of life, nutrition, psychological wellbeing
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality health platform during hemodialysisOther
Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis. The game will also aim at providing nutritional advice, and improving psychological wellbeing and cognitive function.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality health platform during hemodialysis | Experimental | During 12 weeks subjects will use a VR platform during hemodialysis. The intervention will be virtual reality exercise, nutritional advice and psychological wellbeing support plus cognitive training. Receives: Other: Virtual reality health platform during hemodialysis |
| Control group-usual care | No intervention | During 12 weeks subjects will carry on with the usual care in the hemodialysis unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks
More meters walked in 6 minutes mean a better walking capacity
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Secondary outcomes (21)
Change from baseline health-related quality of life assessed by the Short Form 36 questionnaire at 12 weeks
The short form 36 gives data on 8 subscales and 2 components, higher score mean better health-related quality of life The scores range from 0 to 100, with 100 indicating optimal health and 0 reflecting very poor health.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline stance from a chair capacity assessed by the sit to stand 10 at 12 weeks
Time in seconds to perform 10 sit to stand repetitions. A decrease in the time to perform the test means better functional capacity to stand up from a chair
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline usual gait speed assessed by a 4 meters gait speed test at 12 weeks
Speed in m/s to cover 4 meters at normal speed. An increase in speed to perform the test means better gait speed
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline handgrip strength assessed by a handgrip dinamometer at 12 weeks
Bilateral handgrip strength measured in kilograms. An increase in handgrip strength means better strength
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline lower limbs strength assessed by a dinamometer at 12 weeks
Bilateral lower limbs muscle strength measured in kilograms. An increase in strength means better strength
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline physical activity level assessed by the human activity profile questionnaire, average activity score at 12 weeks
The average activity score of the human activity profile questionnaire ranges from 0 to 94. . A higher score means a higher physical activity level
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline physical activity level assessed by the international physical activity questionnaire at 12 weeks
The score of the international physical activity questionnaire will be recorded in MET-minutes/week. A higher score means a higher physical activity level
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Percentage of sessions performed from te sessions offered to measure adherence to the educational program
Calculation will be the result of sessions performed/sessions offered
Measured: After 12 weeks of intervention
Healthcare resources expenditure and costs
Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline lean body mass assessed by the bioimpedance spectroscopy at 12 weeks
Lean body mass is a surrogate of muscle mass in kilograms. Increase in lean body mass means increase in muscle mass
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline qualitative assessment in food intake assessed by the Short form food questionnaire at 12 weeks
Qualitative assessment of food intake Short form food questionnaire. Improvement in the dietary quality
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline nutritional status assessed by the 7 point Subjective Global Assessment at 12 weeks
7 point subjective global assessment scores from 1 to 7, the higher the score the better nutritional status
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline cognitive function assessed by the Mini-mental State at 12 weeks
The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline Anxiety assessed by the Hospital Anxiety and Depression Scale at 12 weeks
Scores obtained between 0 and 21. The higher the score obtained, the higher the level of anxiety and depression.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline positive and negative emotions assessed by Positive and Negative Affect Schedule Scale (PANAS) at 12 weeks
It includes 2 subscales (positive affect and negative affect) with 10 items each. Each subscale can contain scores between 10 and 50. The higher the score obtained, the greater the presence of a particular affect.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline depression assessed by the Beck Depression Inventory (BDI) at 12 weeks
The scores range from 0 to 63 points. The higher the score, the greater the severity of depressive symptoms. Four groups are established according to the total score: 0-13, minimal depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline anxiety assessed by the State Trait Anxiety Inventory (STAI) at 12 weeks
Scale composed of 2 subscales. The range of scores for both subscales is between 0 and 60 points so that higher scores reflect greater anxiety.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline perceived stress assessed by the Perceived Stress Scale (PSS) at 12 weeks
Scores obtained in a range of 0 to 56 points. The higher the score obtained, the higher the level of perceived stress.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline cognitive state assessed by the Montreal Cognitive Assessment (MoCA)at 12 weeks
Scores on the MoCA assessment range from 0 to 30. A score of 26 and above is considered normal.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline attention level assessed by the Trail Making Test (TMT) at 12 weeks
Scoring is based on time taken to complete the test, with lower scores being better.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline memory assessed by the Wechsler-IV Memory Scale at 12 weeks
The correction system allows obtaining scalar scores, indices, centiles and confidence intervals, in order to achieve a more flexible interpretation. It is interpreted on the basis of scales. The Spanish scales have been elaborated from a sample of almost 900 subjects aged between16 and 90 years.
Measured: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start31 Mar 2021
- Primary completion31 Jul 2023
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of two groups, intradialysis virtual reality platform or usual care
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Manises, Universitat Politècnica de València, University of Valencia, Karolinska Institutet, Skane University Hospital, KU Leuven, Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Eva SEGURA-ORTÍ, Principal investigator, Universidad CEU Cardenal Herrera, UCH CEU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823286
- Sponsor's protocol ID
- 2020-064-1
- Acronym
- GoodRENal
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2021
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23.
PubMed 28114792Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
PubMed 21719637Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
PubMed 20701722Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
PubMed 20098466Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527.
PubMed 19473613Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.
PubMed 18336134
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVID +: Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform (GoodRENal.eu)
- ClinicalTrials.gov ID
- NCT04823286
- Acronym / sponsor ID
- GoodRENal / 2020-064-1
- Keywords
- exercise, physical function, health related quality of life, nutrition, psychological wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital de Manises, Universitat Politècnica de València, University of Valencia, Karolinska Institutet, Skane University Hospital, KU Leuven, Aristotle University Of Thessaloniki
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is wide evidence regarding the weak points of end-stage Chronic kidney disease (CKD) patients in hemodialysis, and they include three intervention aspects: exercise, nutrition and psychological support. Evidence shows that exercise for patients in hemodialysis results in increased survival rate, functional capacity, strength and health-related quality of life.
Additionally, different studies have shown the benefits of psychological interventions and the positive effect of educational programs on nutritional care for patients in hemodialysis.
Despite the well-known benefits of exercise, this kind of programs are not being implemented in the routine clinical care of hemodialysis patients.
Thus, the GoodRENal project aims to promote healthy lifestyles among dialysis patients in a holistic approach that combines exercise, nutrition and psychological wellbeing plus cognitive functioning addressing adult learners. The project will, in phase 1, explore barriers and facilitators of patients, carers and health professionals towards healthy lifestyle (physical activity, nutrition and psychological well being). In phase 2, the project will develop a health virtual platform including these three dimensions of cares. In summary, the project outputs will be:
- A didactic content in a modular platform to create an educational program for integrated treatments in patients with dialysis
- A guideline to promote healthy lifestyles among dialysis patients for health care providers
- A guideline to promote e healthy lifestyles among dialysis patients for patients and formal - nonformal carers
Detailed description
CKD stage 5D, has a high incidence, 100-200 people per million, and high prevalence, 750-1500 per million. More than 40-50% are above 65 years old, with a lower rate in women but with higher frailty than men. This cohort presents high comorbidity, malnutrition, sedentary behavior, low health-related quality of life, frailty and high dependency levels. Mortality risk is close to 15% per year. Cardiovascular disease is the main cause of death in end-stage CKD. It is also a high risk factor for peripheral artery disease and lower limbs amputation.
Supporting this cohort results in high direct and indirect costs. Additionally, these patients present high anxiety and depression rates. Comorbidity between depression and somatic illness leads to a significant increase of the illness load since there is higher symptomatology, higher morbidity, higher health costs, and worse functioning and quality of life. Current evidence suggests a bidirectional relationship between depression and medical illness. Mechanisms suggested explaining this complex relationship would include both biological and behavioral aspects. Depression is also associated with the worst adherence to treatment of comorbid patients.
There is wide evidence regarding the weak points of end-stage CKD patients in hemodialysis, and they include three intervention aspects: exercise, nutrition and psychological support. Evidence shows that exercise for patients in hemodialysis results in increased survival rate, functional capacity, strength, and health-related quality of life. Additionally, different studies have shown the benefits of psychological interventions and the positive effect of educational programs on nutritional care for patients in hemodialysis. Several combined interventions have been implemented leading to heterogeneous results.
Despite the well-known benefits of exercise, this kind of programs are not being implemented in the routine clinical care of hemodialysis patients. Patients' lack of interest regarding participation in exercise programs, time constraints, and lack of knowledge by health professionals at the hemodialysis units, are some of the factors underpinning the low implementation rate of intradialysis exercise programs.
Virtual reality (VR) refers to computer-generated interactive simulation that offers users the opportunity to participate in environments that look like objects and events of the real world.
VR exercise has been successfully implemented in neuro-rehabilitation, resulting in better balance, gait, and mobility in cerebrovascular accidents, multiple sclerosis, Guillain-Barre syndrome, and Parkinson's disease. Few studies have explored the impact of VR exercise in renal rehabilitation. Three of the partners (Universidad Cardenal Herrera-CEU, Universitat Politècnica de Valéncia, and Hospital de Manises) have implemented two randomized trials of non-immersive VR exercise intradialysis. Currently, those partners are developing a third trial with this technology and they have verified that this type of exercise has good tolerance and high adherence rates. Additionally, it has a positive impact on strength, functional capacity, physical activity level, and health-related quality of life.
Until now, the most traditional way to assess and implement psychological and psycho-educative treatments has been 'face to face'. Nevertheless, more than 50% of people suffering from depression are not being treated appropriately. This is why alternative treatment models to assess and treat are being implemented, and technology (as the internet) is an option to increase the number of patients that can be treated. Additionally, few studies have explored technology as a means to educate renal patients regarding nutrition or psychological health.
Thus, the hypothesis of the present study is that a health virtual platform designed for holistic treatment of patients undertaking hemodialysis will result in health benefits for this cohort, regarding physical activity, nutritional and psychological health. The platform will be designed according to the aims highlighted by experts, barriers, and needs of end-stage CKD patients and their caregivers. As mentioned above, end-stage chronic kidney disease patients have high comorbidity, malnutrition, sedentarism, low health-related quality of life, low physical function, frailty, and high dependency levels. So they rely on non-formal caregivers for their activities of daily living. This cohort presents high anxiety and depression levels and the combination of somatic disease plus depression results in higher symptoms, higher comorbidity, higher health resources, and worst quality of life. Besides, there is a bidirectional relationship between depression and disease, and depression is associated with lower adherence to medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two groups, intradialysis virtual reality platform or usual care
| Arm | Type | Receives |
|---|---|---|
| Virtual reality health platform during hemodialysis | Experimental | Other: Virtual reality health platform during hemodialysisDuring 12 weeks subjects will use a VR platform during hemodialysis. The intervention will be virtual reality exercise, nutritional advice and psychological wellbeing support plus cognitive training. |
| Control group-usual care | No intervention | –During 12 weeks subjects will carry on with the usual care in the hemodialysis unit |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients on hemodialysis medically stable
- Ability to walk to walk at least a few steps, even if walking aids like canes or a walker ar needed
- Life expectancy greater than 6 months
Key exclusion criteria (7 listed)
- Myocardial infarction in the previous 6 weeks
- Angina unstable on exercise or at rest
- Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia.
- Life expectancy less than 6 months
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality health platform during hemodialysisSubjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis. The game will also aim at providing nutritional advice, and improving psychological wellbeing and cognitive function. | Other | Virtual reality health platform during hemodialysis |
Primary outcome
Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
More meters walked in 6 minutes mean a better walking capacity
21 secondary outcomes
Change from baseline health-related quality of life assessed by the Short Form 36 questionnaire at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline stance from a chair capacity assessed by the sit to stand 10 at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline usual gait speed assessed by a 4 meters gait speed test at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline handgrip strength assessed by a handgrip dinamometer at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline lower limbs strength assessed by a dinamometer at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline physical activity level assessed by the human activity profile questionnaire, average activity score at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline physical activity level assessed by the international physical activity questionnaire at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Percentage of sessions performed from te sessions offered to measure adherence to the educational program
Time frame: After 12 weeks of intervention
Healthcare resources expenditure and costs
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline lean body mass assessed by the bioimpedance spectroscopy at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline qualitative assessment in food intake assessed by the Short form food questionnaire at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline nutritional status assessed by the 7 point Subjective Global Assessment at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline cognitive function assessed by the Mini-mental State at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline Anxiety assessed by the Hospital Anxiety and Depression Scale at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline positive and negative emotions assessed by Positive and Negative Affect Schedule Scale (PANAS) at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline depression assessed by the Beck Depression Inventory (BDI) at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline anxiety assessed by the State Trait Anxiety Inventory (STAI) at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline perceived stress assessed by the Perceived Stress Scale (PSS) at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline cognitive state assessed by the Montreal Cognitive Assessment (MoCA)at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline attention level assessed by the Trail Making Test (TMT) at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Change from baseline memory assessed by the Wechsler-IV Memory Scale at 12 weeks
Time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 28114792Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23.
- Background: PubMed 21719637Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
- Background: PubMed 20701722Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
- Background: PubMed 20098466Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
- Background: PubMed 19473613Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527.
- Background: PubMed 18336134Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva SEGURA-ORTÍ principal investigator
Universidad CEU Cardenal Herrera, UCH CEU
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality health platform during hemodialysis in people with End Stage Renal Disease and Hemodialysis-Induced Symptom, run by Cardenal Herrera University at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Sweden, Belgium, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks (time frame: Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823286, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.