Positive Psychological Intervention Delivered Using Virtual Reality in Patients on Hemodialysis With Comorbid Depression: Protocol and Design for the Joviality Randomized Controlled Trial.

BACKGROUND: Depression is highly prevalent in individuals on hemodialysis, but it is infrequently identified and remains undertreated. In this paper, we present details of the methodology of a randomized controlled trial (RCT) aimed at testing the feasibility and preliminary efficacy of a 5-week positive psychological intervention in individuals on hemodialysis with comorbid depression delivered using immersive virtual reality (VR) technology. OBJECTIVE: We aim to describe the protocol and design of the Joviality trial whose main objectives are 2-fold: determine the feasibility of the Joviality VR software through metrics capturing rates of recruitment, refusal, retention, noncompliance, and adherence, as well as end-user feedback; and assess preliminary efficacy for outcomes measures of depressive symptoms, psychological well-being and distress, quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalizations. METHODS: This 2-arm RCT is scheduled to enroll 84 individuals on hemodialysis with comorbid depression from multiple outpatient centers in Chicago, Illinois, United States. Enrollees will be randomized to the following groups: VR-based Joviality positive psychological intervention or sham VR (2D wildlife footage and nature-based settings with inert music presented using a head-mounted display). To be eligible, individuals must be on hemodialysis for at least 3 months, have Beck Depression Inventory-II scores of ≥11 (ie, indicative of mild-to-severe depressive symptoms), be aged ≥21 years, and be fluent in English or Spanish. The Joviality VR software was built using agile design principles and incorporates fully immersive content, digital avatars, and multiplex features of interactability. Targeted skills of the intervention include noticing positive events, positive reappraisal, gratitude, acts of kindness, and mindful or nonjudgmental awareness. The primary outcomes include metrics of feasibility and acceptability, along with preliminary efficacy focused on decreasing symptoms of depression. The secondary and tertiary outcomes include quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalization rates. There are 4 assessment time points: baseline, immediately after the intervention, 3 months after the intervention, and 6 months after the intervention. We hypothesize that depressive symptoms and hemodialysis-related markers of disease will substantially improve in participants randomized to the VR-based Joviality positive psychology treatment arm compared with those in the attention control condition. RESULTS: This RCT is funded by the National Institute of Diabetes and Digestive and Kidney Diseases and is scheduled to commence participant recruitment in June 2023. CONCLUSIONS: This trial will be the first to test custom-built VR software to deliver a positive psychological intervention, chairside, in individuals on hemodialysis to reduce symptoms of depression. Within the context of an RCT using an active control arm, if proven effective, VR technology may become a potent tool to deliver mental health programming in clinical populations during their outpatient treatment sessions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05642364; https://clinicaltrials.gov/ct2/show/NCT05642364. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45100.

Effect of the combination of bumetanide plus chlorthalidone on hypertension and volume overload in patients with chronic kidney disease stage 4-5 KDIGO without renal replacement therapy: a double-blind randomized HEBE-CKD trial.

BACKGROUND: The co-administration of loop diuretics with thiazide diuretics is a therapeutic strategy in patients with hypertension and volume overload. The aim of this study was to assess the efficacy and safety of treatment with bumetanide plus chlorthalidone in patients with chronic kidney disease (CKD) stage 4-5 KDIGO. METHODS: A double-blind randomized study was conducted. Patients were randomized into two groups: bumetanide plus chlorthalidone group (intervention) and the bumetanide plus placebo group (control) to evaluate differences in TBW, ECW and ECW/TBW between baseline and 30 Days of follow-up. Volume overload was defined as 'bioelectrical impedance analysis as fluid volume above the 90th percentile of a presumed healthy reference population. The study's registration number was NCT03923933. RESULTS: Thirty-two patients with a mean age of 57.2 ± 9.34 years and a median estimated glomerular filtration rate (eGFR) of 16.7 ml/min/1.73 m2 (2.2-29) were included. There was decreased volume overload in the liters of total body water (TBW) on Day 7 (intervention: -2.5 vs. control: -0.59, p = 0.003) and Day 30 (intervention: -5.3 vs. control: -0.07, p = 0.016); and in liters of extracellular water (ECW) on Day 7 (intervention: -1.58 vs. control: -0.43, p < 0.001) and Day 30 (intervention: -3.05 vs. control: -0.15, p < 0.000). There was also a decrease in systolic blood pressure on Day 7 (intervention: -18 vs. control: -7.5, p = 0.073) and Day 30 (intervention: -26.1 vs. control: -10, p = 0.028) and in diastolic blood pressure on Day 7 (intervention: -8.5 vs. control: -2.25, p = 0.059) and Day 30 (intervention: -13.5 vs. control: -3.4, p = 0.018). CONCLUSION: In CKD stage 4-5 KDIGO without renal replacement therapy, bumetanide in combination with chlorthalidone is more effective in treating volume overload and hypertension than bumetanide with placebo.

Effect of Intradialytic Oral Nutritional Supplementation with or without Exercise Improves Muscle Mass Quality and Physical Function in Hemodialysis Patients: A Pilot Study.

BACKGROUND: Oral nutritional supplementation (ONS) with or without exercise (EX) could improve muscle mass (MM) in chronic kidney disease. METHODS: Patients were randomized into two groups: (1) ONS and (2) ONS + EX. Thigh muscle area (cm2) and intramuscular lipid content via attenuation were evaluated at baseline and 6 months with computed tomography (CT) to measure MM quantity and quality. Physical function was measured by six-minute walk test (6 MWT), gait speed, handgrip strength (HGS), and Time Up and Go test (TUG) at baseline and 3 and 6 months. RESULTS: The ONS group (n= 14) showed statistically significant improvement in gait speed and HGS; ONS + EX group (n = 10) showed differences in gait speed, in 6 MWT, and HGS. In the ANOVA (3 times × 2 groups), no differences were observed between groups. Greater effect sizes in favor to ONS + EX group were observed in the 6 MWT (d = 1.02) and TUG test (d = 0.63). Muscle quality at six months revealed a significant trend in favor of the EX-group (p = 0.054). CONCLUSIONS: Both groups had improved physical function, and greater effect sizes were seen in the ONS + EX group for the 6 MWT and TUG test. Neither MM quantity or quality was improved in either group.

Changes in cardiometabolic risk factors and metabolic syndrome over time in living kidney donors: a retrospective cohort study / Cambios en los factores de riesgo cardiometabólico y el síndrome metabólico a través del tiempo en los donantes renales vivos: estudio de cohortes retrospectivo

Background: permissibility in the selection of living kidney donors (LKD) with one or more cardiometabolic risk factors (CMRFs) and/or metabolic syndrome (MS) is an increasingly frequent practice worldwide. These factors, together with kidney donation specifically, are known to be associated with an increased risk of chronic kidney disease (CKD). Methods: we analyzed the frequency of CMRFs and MS before and after kidney donation in LKD. In the secondary analysis, we associated CMRFs and MS with renal function. The SPSS V22.0 software was used. Results: we analyzed 110 LKD patients, with a mean age of 35.05 ± 10.5 years: 63 (57.3 %) men and 47 (42.7 %) women. Patients were followed for 25 ± 17.48 months after nephrectomy. Prior to donation, 62 patients (56.4 %) had MS, and the presence of one to six CMRFs was 19.1 %, 32 %, 18.2 %, 17.3 %, 3.6 %, and 0.9 %, respectively. During follow-up, in donors, the incidence of overweight increased from 48.2 % to 52.7 %, (p < 0.01); that of obesity increased from 11.8 % to 20.9 % (p < 0.01); that of hyperuricemia increased from 17.3 % to 26.4 %, (p < 0.01); that of hypercholesterolemia increased from 24.5 % to 33.6 % (p < 0.01); and that of hypertriglyceridemia increased from 47.3 % to 50.9 % (p < 0.01), while the incidence of MS decreased from 56.4 % to 51.8 % (p < 0.01). A logistic regression analysis showed that the presence of CMRFs did not show any association with glomerular filtration rates below 60 mL/min/1.73 m2. (AU)

Introducción: la permisibilidad en la selección de los donantes renales vivos (DRV) con uno o más factores de riesgo cardiometabólico (FRCM) y/o síndrome metabólico (SM) es una práctica cada vez más frecuente en todo el mundo. Se sabe que estos factores, junto con la donación de riñón, específicamente, están asociados con un mayor riesgo de enfermedad renal crónica (ERC). Métodos: analizamos la frecuencia de los FRCM y SM antes y después de la donación renal en DRV. En el análisis secundario, asociamos los FRCM y la SM con la función renal. Se utilizó el programa SPSS V22.0. Resultados: se analizaron 110 DRV con una edad media de 35,05 ± 10,5 años: 63 (57,3 %) hombres y 47 (42,7 %) mujeres. Los pacientes fueron seguidos durante 25 ± 17,48 meses después de la nefrectomía. Antes de la donación, 62 pacientes (56,4 %) tenían SM y la presencia de uno a seis FRCM era del 19,1 %, 32 %, 18,2 %, 17,3 %, 3,6 % y 0,9 %, respectivamente. Durante el seguimiento, en los donantes, la incidencia del sobrepeso aumentó del 48,2 % al 52,7 % (p < 0,01); la de la obesidad pasó del 11,8 % al 20,9 % (p < 0,01); la de la hiperuricemia aumentó del 17,3 % al 26,4 % (p < 0,01); la de la hipercolesterolemia aumentó del 24,5 % al 33,6 % (p < 0,01); y la de la hipertrigliceridemia aumentó del 47,3 % al 50,9 % (p < 0,01), mientras que la incidencia del SM disminuyó del 56,4 % al 51,8 % (p < 0,01). El análisis de regresión logística mostró que la presencia de FRCM no presentaba ninguna asociación con las tasas de filtración glomerular por debajo de 60 ml/min/1,73 m2. (AU)

Changes in cardiometabolic risk factors and metabolic syndrome over time in living kidney donors: a retrospective cohort study.

INTRODUCTION: Background: permissibility in the selection of living kidney donors (LKD) with one or more cardiometabolic risk factors (CMRFs) and/or metabolic syndrome (MS) is an increasingly frequent practice worldwide. These factors, together with kidney donation specifically, are known to be associated with an increased risk of chronic kidney disease (CKD). Methods: we analyzed the frequency of CMRFs and MS before and after kidney donation in LKD. In the secondary analysis, we associated CMRFs and MS with renal function. The SPSS V22.0 software was used. Results: we analyzed 110 LKD patients, with a mean age of 35.05 ± 10.5 years: 63 (57.3 %) men and 47 (42.7 %) women. Patients were followed for 25 ± 17.48 months after nephrectomy. Prior to donation, 62 patients (56.4 %) had MS, and the presence of one to six CMRFs was 19.1 %, 32 %, 18.2 %, 17.3 %, 3.6 %, and 0.9 %, respectively. During follow-up, in donors, the incidence of overweight increased from 48.2 % to 52.7 %, (p < 0.01); that of obesity increased from 11.8 % to 20.9 % (p < 0.01); that of hyperuricemia increased from 17.3 % to 26.4 %, (p < 0.01); that of hypercholesterolemia increased from 24.5 % to 33.6 % (p < 0.01); and that of hypertriglyceridemia increased from 47.3 % to 50.9 % (p < 0.01), while the incidence of MS decreased from 56.4 % to 51.8 % (p < 0.01). A logistic regression analysis showed that the presence of CMRFs did not show any association with glomerular filtration rates below 60 mL/min/1.73 m2. Conclusion: LKD had a high frequency of CMRFs and MS at the time of donation, and over time, the incidence of CMRFs significantly increased. Because these factors, together with kidney donation, could be associated with an increased risk of CKD, we must evaluate protocols for LKD and consider stricter criteria in the selection of LKD, with an emphasis on follow-up protocols to address CMRFs and MS.

INTRODUCCIÓN: Introducción: la permisibilidad en la selección de los donantes renales vivos (DRV) con uno o más factores de riesgo cardiometabólico (FRCM) y/o síndrome metabólico (SM) es una práctica cada vez más frecuente en todo el mundo. Se sabe que estos factores, junto con la donación de riñón, específicamente, están asociados con un mayor riesgo de enfermedad renal crónica (ERC). Métodos: analizamos la frecuencia de los FRCM y SM antes y después de la donación renal en DRV. En el análisis secundario, asociamos los FRCM y la SM con la función renal. Se utilizó el programa SPSS V22.0. Resultados: se analizaron 110 DRV con una edad media de 35,05 ± 10,5 años: 63 (57,3 %) hombres y 47 (42,7 %) mujeres. Los pacientes fueron seguidos durante 25 ± 17,48 meses después de la nefrectomía. Antes de la donación, 62 pacientes (56,4 %) tenían SM y la presencia de uno a seis FRCM era del 19,1 %, 32 %, 18,2 %, 17,3 %, 3,6 % y 0,9 %, respectivamente. Durante el seguimiento, en los donantes, la incidencia del sobrepeso aumentó del 48,2 % al 52,7 % (p < 0,01); la de la obesidad pasó del 11,8 % al 20,9 % (p < 0,01); la de la hiperuricemia aumentó del 17,3 % al 26,4 % (p < 0,01); la de la hipercolesterolemia aumentó del 24,5 % al 33,6 % (p < 0,01); y la de la hipertrigliceridemia aumentó del 47,3 % al 50,9 % (p < 0,01), mientras que la incidencia del SM disminuyó del 56,4 % al 51,8 % (p < 0,01). El análisis de regresión logística mostró que la presencia de FRCM no presentaba ninguna asociación con las tasas de filtración glomerular por debajo de 60 ml/min/1,73 m2. Conclusión: los DRV tuvieron una alta frecuencia de FRCM y SM en el momento de la donación y, con el tiempo, la incidencia aumentó significativamente. Debido a que estos factores, junto con la donación de riñón, podrían estar asociados a un mayor riesgo de ERC, debemos evaluar los protocolos de los DRV y considerar criterios más estrictos en la selección de estos donantes, haciendo énfasis en los protocolos de seguimiento para tratar los FRCM y el SM.

Effect of Oral Nutritional Supplementation With and Without Exercise on Nutritional Status and Physical Function of Adult Hemodialysis Patients: A Parallel Controlled Clinical Trial (AVANTE-HEMO Study).

OBJECTIVE: Protein energy wasting affects the nutritional status (NS) and physical function (PF) of dialysis patients. Among the different anabolic strategies to improve NS and PF, oral nutritional supplementation (ONS) and resistance exercise (RE) or aerobic exercise (AE) have been shown to be effective. Nevertheless, the combination of both anabolic strategies has not been completely evaluated. The aim of this study is to assess the effect of exercise combined with ONS versus ONS without exercise during hemodialysis sessions on PF and NS indicators. METHODS: Young hemodialysis patients (29 ± 9.3 years) with predominantly unknown causes of renal disease (80%) were divided into the following 3 groups during a period of 12 weeks: (1) ONS (n = 15), (2) ONS + RE (n = 15), and (3) ONS + AE (n = 15). Anthropometric, biochemical, PF, and quality of life measurements were recorded at baseline and after 3 months. Repeated measures analysis of variance and effect sizes (Cohen's d) were used to assess the effect of exercise and nutrition (ISRCTN registry 10251828). RESULTS: At the completion of the study, the ONS and ONS + RE groups exhibited statistically significant increases in body weight, body mass index, and in the percentage of fat mass (P < .05); the greatest effect sizes were observed in the ONS + RE group (d = 0.30 for body weight, d = 0.63 for body mass index, and d = 0.90 for the percentage of fat mass). Groups with RE and AE had statistically significant increases and large effect sizes in the six-minute walk test (RE: d = 0.94, P = .02; AE: d = 1.11, P = .03), sit-to-stand test (RE: d = 0.81, P = .041; AE: d = 1.20, P = .002), timed up and go test (RE: d = 1.04, P = .036; AE: d = 1.6, P = .000), and muscle strength (RE: d = 1.01, P = .000; AE: d = 0.60, P = .003). Regarding quality of life, the ONS + RE group had more areas of improvement at the end of the study, followed by the ONS + AE group. No statistically significant differences were found in the repeated measures ANOVA. CONCLUSIONS: The combination of exercise with ONS had larger effects on PF than on ONS alone. Further studies to examine the impact of exercise on the effect of oral nutritional supplementation in dialysis patients are indicated.

Mortality in Patients With Chronic Renal Disease Without Health Insurance in Mexico: Opportunities for a National Renal Health Policy.

INTRODUCTION: Despite a systematic increase in the coverage of patients with end-stage renal disease (ESRD) who have received dialytic therapies and transplantation over the past 2 decades, the Mexican health system currently still does not have a program to provide full coverage of ESRD. Our aim was to analyze mortality in patients with ESRD without health insurance. METHODS: This was a prospective cohort study of 850 patients with advanced chronic kidney disease (CKD). Risk factors associated with death were calculated using a Cox's proportional hazards model. We used the statistical package SPSS version 22.0 for data analysis. RESULTS: The mean age of patients was 44.8 ± 17.2 years old. At the time of hospital admission, 87.6% of the population did not have a social security program to cover the cost of renal replacement treatment, and 91.3% of families had an income below US$300 per month. During the 3 years of the study, 28.8% of the cohort patients were enrolled in 1 of Mexico's social security programs. The 3-year mortality rate was of 56.7% among patients without access to health insurance, in contrast to 38.2% of patients who had access to a social security program that provided access to renal replacement therapy (P < 0.001). Risk factor analysis revealed that not having health insurance increased mortality (risk ratio: 2.64, 95% confidence intervals: 1.84-3.79; P = 0.001). CONCLUSION: Mexico needs a coordinated National Kidney Health and Treatment Program. A program of this nature should provide the basis for an appropriate educational and intervention strategy for early detection, prevention, and treatment of patients with advanced chronic kidney disease.

The effects of resistance exercise and oral nutritional supplementation during hemodialysis on indicators of nutritional status and quality of life.

BACKGROUND: Protein-energy wasting (PEW) is common in patients undergoing hemodialysis (HD). Studies have assessed the positive effect of oral nutritional supplementation (ONS) or resistance exercise (RE) on nutritional status (NS) markers in patients undergoing HD. METHODS: The aim of this study was to assess the effect of ONS and RE on NS and the quality of life (QOL) of 36 patients undergoing HD. In a randomized clinical trial, patients were divided into the following two groups: a control group (ONS) that received a can of ONS during their HD sessions and an intervention group (ONS + RE) that received a can of ONS and underwent a 40-min session of RE during their HD sessions. Both interventions lasted 12 weeks. The patients' anthropometric, biochemical, dietetic and bioelectrical impedance measurements as well as their QOL, evaluated using the Kidney Disease Quality of Life Short Form, were recorded. RESULTS: At baseline, 55.5% of patients presented with PEW according to International Society of Renal Nutrition and Metabolism criteria (20 patients). We found statistically significant changes from baseline in both groups, such as increases in body weight, body mass index, midarm circumference, midarm muscle circumference, triceps skinfold thickness, fat mass percentage, handgrip strength, phase angle and serum albumin. A decrease in the prevalence of PEW was observed in both groups at the end of the intervention. A delta comparison between groups showed no statistically significant differences in the anthropometric and biochemical parameters. No significant improvement was observed in QOL and body composition measured by bioimpedance vector analysis. Dietary energy and protein intake increased significantly during the study period for all patients. CONCLUSION: Oral nutritional supplementation during HD improves NS. The addition of RE during HD does not seem to augment the acute anabolic effects of intradialytic ONS on NS.