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

• ClinicalTrials.gov Identifier: NCT04823286
• Recruitment Status: Recruiting
• First Posted: March 30, 2021
• Last Update Posted: February 13, 2023
• Sponsor: Cardenal Herrera University
• Collaborators: Hospital de Manises; Universitat Politècnica de València; University of Valencia; Karolinska Institutet; Skane University Hospital; KU Leuven; Aristotle University Of Thessaloniki
• Information provided by (Responsible Party): Eva Segura Ortí, Cardenal Herrera University

Study Description

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

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease; Hemodialysis-Induced Symptom; Chronic Kidney Diseases	Other: Virtual reality health platform during hemodialysis	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomized into one of two groups, intradialysis virtual reality platform or usual care
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: A team of assessors, different to the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
• Primary Purpose: Treatment
• Official Title: REVID +: Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform (GoodRENal.eu)
• Actual Study Start Date: March 31, 2021
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: August 31, 2023

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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.
10. 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
11. 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
12. 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
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Eva SEGURA-ORTÍ, PhD; 00 34 671580094; eva.segura@gmail.com

Locations

Belgium

KU Leuven; Not yet recruiting

Leuven, Belgium, 3000

Contact: Amaryllis H Van Craenenbroeck, PhD Amaryllis.vancraenenbroeck@kuleuven.be

Greece

Aristotle University of Thessaloniki; Recruiting

Thessaloníki, Greece, 57001

Contact: Evangelia Kouidi, PhD kouidi@phed.auth.gr

Spain

Hospital de Manises; Recruiting

Manises, Valencia, Spain, 46940

Contact: Eva SEGURA-ORTÍ, PhD 00 34 671580094 eva.segura@gmail.com

Universitat de Valencia; Enrolling by invitation

Valencia, Spain, 46010

Universitat Politécnica de Valéncia; Enrolling by invitation

Valencia, Spain, 46022

Sweden

Skane Univeristy Hospital; Not yet recruiting

Lund, Sweden

Contact: Naomi Clyne, PhD Naomi.Clyne@med.lu.se

Karolinska Institute; Enrolling by invitation

Stockholm, Sweden, 14186

Sponsors and Collaborators

Cardenal Herrera University

Hospital de Manises

Universitat Politècnica de València

University of Valencia

Karolinska Institutet

Skane University Hospital

KU Leuven

Aristotle University Of Thessaloniki

Investigators

• Principal Investigator: Eva SEGURA-ORTÍ; Universidad CEU Cardenal Herrera, UCH CEU

More Information

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.

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.

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.

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.

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.

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.

• Responsible Party: Eva Segura Ortí, Professor, Cardenal Herrera University
• ClinicalTrials.gov Identifier: NCT04823286
• Other Study ID Numbers: 2020-064-1
• First Posted: March 30, 2021
• Last Update Posted: February 13, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eva Segura Ortí, Cardenal Herrera University:

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

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes