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

NCT ID: NCT04823286

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2026-08-31

Brief 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. 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

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.

Conditions

End Stage Renal Disease; Hemodialysis-Induced Symptom; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual reality health platform during hemodialysis

Intervention Type: OTHER

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.

Control group-usual care

During 12 weeks subjects will carry on with the usual care in the hemodialysis unit

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Manises

OTHER

Sponsor Role: collaborator

Universitat Politècnica de València

OTHER

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: collaborator

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Eva Segura Ortí

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva SEGURA-ORTÍ

Role: PRINCIPAL_INVESTIGATOR

Universidad CEU Cardenal Herrera, UCH CEU

Locations

KU Leuven

Leuven, , Belgium

Aristotle University of Thessaloniki

Thessaloniki, , Greece

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Hospital de Manises

Manises, Valencia, Spain

Universitat de Valencia

Valencia, Valencia, Spain

Universitat Politécnica de Valéncia

Valencia, Valencia, Spain

Skane Univeristy Hospital

Lund, , Sweden

Karolinska Institute

Stockholm, , Sweden

Countries

Belgium; Greece; Spain; Sweden

References

Segura-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.

Reference Type: BACKGROUND

PMID: 19473613 (View on PubMed)

Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.

Reference Type: BACKGROUND

PMID: 18336134 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28114792 (View on PubMed)

Segura-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.

Reference Type: BACKGROUND

PMID: 21719637 (View on PubMed)

Segura-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.

Reference Type: BACKGROUND

PMID: 20701722 (View on PubMed)

Segura-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.

Reference Type: BACKGROUND

PMID: 20098466 (View on PubMed)

Other Identifiers

2020-064-1

Identifier Type: -

Identifier Source: org_study_id