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Clinical Trials in Belgium / NCT04823286
Active, not recruiting Not applicable

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

NCT04823286 · tracked via the Priya Life Science Belgium tracker
Sponsor
Cardenal Herrera University
Phase
Not applicable
Started
2021-03-31
Last updated
2026-01-23

Condition(s) studied

End Stage Renal DiseaseHemodialysis-Induced SymptomChronic Kidney Diseases

Investigational drug(s) / intervention(s)

Virtual reality health platform during hemodialysis

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks — 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

Trial sites (8)

FacilityCityRegionStatus
KU Leuven Leuven Belgium
Aristotle University of Thessaloniki Thessaloniki Greece
Consorci Sanitari de Terrassa Terrassa Barcelona
Hospital de Manises Manises Valencia
Universitat de Valencia Valencia Valencia
Universitat Politécnica de Valéncia Valencia Valencia
Skane Univeristy Hospital Lund Sweden
Karolinska Institute Stockholm Sweden

Other trials for the same condition

Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term) Active, not recruiting
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN Active, not recruiting
CKD Cachexia and Gut Microbiome Recruiting
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension Recruiting
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04823286 on ClinicalTrials.gov ↗ ← All trials in Belgium