Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform (GoodRENal)

January 21, 2026 updated by: Eva Segura Ortí, Cardenal Herrera University

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.

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:

  1. A didactic content in a modular platform to create an educational program for integrated treatments in patients with dialysis
  2. A guideline to promote healthy lifestyles among dialysis patients for health care providers
  3. A guideline to promote e healthy lifestyles among dialysis patients for patients and formal - nonformal carers

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KU Leuven
  • Greece
      • Thessaloniki, Greece, 57001
        • Aristotle University Of Thessaloniki
  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain
        • Consorci Sanitari de Terrassa
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises
      • Valencia, Valencia, Spain, 46010
        • Universitat de Valencia
      • Valencia, Valencia, Spain, 46022
        • Universitat Politécnica de Valéncia
  • Sweden
      • Lund, Sweden
        • Skane Univeristy Hospital
      • Stockholm, Sweden, 14186
        • Karolinska Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual reality health platform during hemodialysis
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.
Other: Virtual reality health platform during hemodialysis
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.
No Intervention: Control group-usual care
During 12 weeks subjects will carry on with the usual care in the hemodialysis unit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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
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
Speed in m/s to cover 4 meters at normal speed. An increase in speed to perform the test means better gait speed
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
Bilateral handgrip strength measured in kilograms. An increase in handgrip strength means better strength
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
Bilateral lower limbs muscle strength measured in kilograms. An increase in strength means better strength
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
The average activity score of the human activity profile questionnaire ranges from 0 to 94. . A higher score means a higher physical activity level
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
The score of the international physical activity questionnaire will be recorded in MET-minutes/week. A higher score means a higher physical activity level
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
Calculation will be the result of sessions performed/sessions offered
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
Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.
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
Lean body mass is a surrogate of muscle mass in kilograms. Increase in lean body mass means increase in muscle mass
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
Qualitative assessment of food intake Short form food questionnaire. Improvement in the dietary quality
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
7 point subjective global assessment scores from 1 to 7, the higher the score the better nutritional status
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
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.
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
Scores obtained between 0 and 21. The higher the score obtained, the higher the level of anxiety and depression.
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
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.
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
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.
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
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.
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
Scores obtained in a range of 0 to 56 points. The higher the score obtained, the higher the level of perceived stress.
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
Scores on the MoCA assessment range from 0 to 30. A score of 26 and above is considered normal.
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
Scoring is based on time taken to complete the test, with lower scores being better.
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
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.
Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardenal Herrera University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet
KU Leuven
Aristotle University Of Thessaloniki
University of Valencia
Skane University Hospital
Hospital de Manises
Universitat Politècnica de València

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eva SEGURA-ORTÍ, Universidad CEU Cardenal Herrera, UCH CEU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-064-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Virtual reality health platform during hemodialysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings