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

NCT04823286 | Active Not Recruiting

• 1 other identifier: 2020-064-1
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 8

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

Conditions

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

Keywords

exercise; physical function; health related quality of life; nutrition; psychological wellbeing

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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

  Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention

Study Arms (2)

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.

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

Interventions

Virtual reality health platform during hemodialysis 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.

Virtual reality health platform during hemodialysis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Manises: collaborator
• Universitat Politècnica de València: collaborator
• University of Valencia: collaborator
• Karolinska Institutet: collaborator
• KU Leuven: collaborator
• Aristotle University Of Thessaloniki: collaborator
• Cardenal Herrera University: lead
• Skane University Hospital: collaborator

Study Sites (8)

KU Leuven

Leuven, 3000, Belgium

Location

Aristotle University of Thessaloniki

Thessaloniki, 57001, Greece

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Location

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Universitat de Valencia

Valencia, Valencia, 46010, Spain

Location

Universitat Politécnica de Valéncia

Valencia, Valencia, 46022, Spain

Location

Skane Univeristy Hospital

Lund, Sweden

Location

Karolinska Institute

Stockholm, 14186, Sweden

Location

Related Publications (6)

• 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.

  PMID: 28114792 BACKGROUND

• 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.

  PMID: 21719637 BACKGROUND

• 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.

  PMID: 20701722 BACKGROUND

• 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.

  PMID: 20098466 BACKGROUND

• 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.

  PMID: 19473613 BACKGROUND

• 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.

  PMID: 18336134 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Eva SEGURA-ORTÍ

  Universidad CEU Cardenal Herrera, UCH CEU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A team of assessors, different to the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized into one of two groups, intradialysis virtual reality platform or usual care

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: March 30, 2021
• Study Start: March 31, 2021
• Primary Completion: July 31, 2023
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); BE (1); ES (4); GR (1)