Twelve weeks of combined physical and cognitive intradialytic training preserves alertness and improves gait speed: a randomized controlled trial.

BACKGROUND: Hemodialysis (HD) patients often experience cognitive deficits and reduced mobility. While studies have shown promising results of physical and/or cognitive training in older adults, their effects in HD patients remain understudied. AIMS: This study aimed to evaluate the impact of a 12-week intradialytic training program combining cognitive training with physical exercise on attention domains and spontaneous gait speed (SGS) in HD patients. METHODS: Forty-four HD patients were randomly assigned to either intradialytic cognitive and physical exercise training (EXP group; n = 22) or a standard care control group (CON group; n = 22). The EXP group performed intradialytic cycling and tablet-based cognitive training three days per week for 12 weeks. The primary outcome of the study was performance on the computerized test battery 'Test of Attentional Performance.' Secondary study outcome was patient mobility assessed by the four-meter SGS. Outcomes were assessed pre- and post-intervention. RESULTS: Significant group x time interaction was observed in alertness (F(1,41) = 6.15, p = 0.017) and SGS (F(1,41) = 18.33, p < 0.001) in favor of the EXP group. Within-group analysis revealed a significant pre-post decline in the CON group in alertness test (-26.7 s; p = 0.04) and an improvement of SGS in EXP group (+ 0.07 s; p < 0.001). DISCUSSION: This original study demonstrated that a combined physical and cognitive intradialytic training intervention led to improvements in SGS and preservation in alertness compared to a deterioration in the CON group. CONCLUSION: Findings suggest that the intervention may serve as an effective tool to prevent the physical and cognitive decline in this patient population.

Use of regional citrate anticoagulation with medium cut-off membrane: pilot report.

BACKGROUND: Regional citrate anticoagulation during hemodialysis provides an immediate and complete anticoagulant effect, which is limited to the extracorporeal circuit. Citrate has become the standard anticoagulant in acute renal replacement therapy and is widely used in various intermittent hemodialysis modalities, especially for patients with contraindications for heparin. With the increased adoption of medium cut-off membranes, experience with regional citrate anticoagulation is needed. To our knowledge, this is the first report to assess the feasibility of regional citrate anticoagulation in expanded hemodialysis. METHODS: We prospectively analyzed 5 expanded hemodialysis procedures in 5 patients in which a medium cut-off membrane (Theranova®) was used. We followed our standard citrate protocol developed and tested for high-flux membrane. Anticoagulation was performed with a continuous infusion of 8% trisodium citrate into the arterial line and supplementation of 1 M calcium chloride into the venous line. We monitored ionized calcium and magnesium, sodium and blood gas analysis. Anticoagulation effectiveness was assessed by post-filter ionized calcium and by visual inspection of the anticoagulation in the circuit. RESULTS: There were no prematurely terminated procedures due to anticoagulation-related complications. With a blood flow of 250 mL/min and a dialysate flow of 500 mL/min, we were able to maintain serum ionized calcium in the range of 0.89-1.29 mmol/L and serum sodium in the range of 136-144 mmol/L. The mean pre- and post-dialysis arterial circuit pH was 7.42 (± 0.04) and 7.53 (± 0.23), respectively. The mean pre- and post-dialysis serum ionized magnesium was 0.54 (± 0.04) mmol/L and 0.43 (± 0.03) mmol/L, respectively (measurements were done on a point-of-care ionometer with a lower normal range for ionized magnesium). CONCLUSION: We have shown that our standard citrate protocol for high-flux hemodialysis membrane could be successfully adopted for use in expanded hemodialysis with a medium cut-off membrane. Overall, electrolyte and acid-base balances were relatively well-controlled and anticoagulation effectiveness was excellent. TRIAL REGISTRATION: This is a pilot report with results taken from a larger ongoing trial (registered at ClinicalTrials.gov on October 25, 2019 under number NCT04139525) comparing citrate and heparin anticoagulation during expanded hemodialysis.

Nutrient and Food Intake of Participants in a Whole-Food Plant-Based Lifestyle Program.

OBJECTIVE: We evaluated the nutrient adequacy of a well-planned supplemented whole-food plant-based (WFPB) diet as a component of an ongoing community lifestyle optimization program. We investigated the contributions of nutrients from foods and supplements and plant-based meal replacement (SMR) separately (foods, SMR) and combined (vs recommendations) as well as food group intake, both according to sex. METHOD: Our cross-sectional study included 151 healthy, active participants (aged 39.6 years) who were on a Western-type diet when they voluntarily joined our WFPB lifestyle program (0.5-10 years ago). We assessed diet using 3-day weighed dietary records (foods, S, and MR). After we standardized nutrient intake to 2000 kcal/d, we calculated the contribution of macro- and micronutrients from foods and SMR separately and combined (foods + SMR) (vs central European Recommendations), as well as food group intake, both according to sex. RESULTS: All macro- and micronutrient intake (total: from foods plus SMR) exceeded the reference values, except for calcium (95% and 82% in females and males) and vitamin D (both sexes, in summertime). Compared with male participants, female participants consumed (i.e., from foods and SMR together) significantly larger amounts of 23 (/25) micronutrients (8 [/25] from foods and 22 [/25] from SMR). The diet was primarily composed of the following (by mass in descending order): unprocessed vegetables/fruits, whole grains, legumes, potatoes, nuts/seeds, MR, and spices/herbs. CONCLUSIONS: Participants in our WFPB lifestyle program ingested a nutrient-rich WFPB diet and targeted supplementation. The presented ongoing community WFPB lifestyle program ensures a healthy, balanced, and environment-friendly dietary pattern for participants who are compliant.

Functional training added to intradialytic cycling lowers low-density lipoprotein cholesterol and improves dialysis adequacy: a randomized controlled trial.

BACKGROUND: Exercise has various positive effects on hemodialysis patients. However, there is no clear evidence which type of exercise yields better results. This study aimed to determine the effects of guided functional training added to the intradialytic cycling on dialysis adequacy and biochemical parameters in hemodialysis patients. Additionally, we aimed to investigate if patients could transfer functional exercise to an unsupervised home environment and retain gained improvements. METHODS: Randomization was done to a functional training intervention group (INT) (n = 20) or intradialytic cycling control group (CON) (n = 20). The INT attended a pre-dialysis functional training in the first 8 weeks. In the second 8 weeks, they performed functional exercises at unsupervised home environment on non-dialysis days. During the whole study, both groups participated in the intradialytic cycling program. RESULTS: Both groups demonstrated a significant increase in dialysis adequacy (Kt/V) in the eight (0.15, 95% CI 0.06 to 0.24; p = 0.003 for INT and 0.21, 95% CI 0.11 to 0.3; p < 0.001 for CON) and the 16th study week (0.13, 95% CI 0.03 to 0.24; p = 0.017 for INT and 0.13, 95% CI 0.03 to 0.22; p = 0.013 for CON) compared to their baseline values with no significant between-group differences. At week eight, the total cholesterol was significantly lowered in the INT (- 0.34 mmol/L, 95% CI - 0.6 to - 0.07; p = 0.016) and remained lower at week 16 (- 0.32 mmol/L, 95% CI - 0.64 to - 0.01; p = 0.049) with no significant changes in the CON. Low-density lipoprotein levels in the INT were significantly reduced after 8 weeks (- 0.35 mmol/L, 95% CI - 0.64 to - 0.06; p = 0.022) and remained reduced after 16 weeks (- 0.28 mmol/L, 95% CI - 0.52 to - 0.03; p = 0.030). There were no significant differences found for albumin, high-density lipoprotein cholesterol, triglycerides, C-reactive protein, and hemoglobin in both groups. CONCLUSIONS: We demonstrated that functional training added to intradialytic cycling improved lipid profile and dialysis adequacy. Additionally, the effects of the unsupervised, home-based program were preserved during the second study phase. This study supports the assumption that combined training is more effective compared to solely intradialytic exercise. TRIAL REGISTRATION: ClinicalTrials.Gov, NCT03334123 . Registered 07 November 2017.

Physical function and 25-hydroxyvitamin D in dialysis patients - lessons learned from the Slovenian DIAGIB study.

AIMS: Vitamin D stores in dialysis patients may be associated with their muscle function and physical performance. We analyzed associations of 25-hydroxyvitamin D levels with functional test results in prevalent hemodialysis patients and healthy controls. METHODS: Study sample included 54 dialysis patients and 81 healthy controls who performed a 6-minute walk test, sit-to-stand test, handgrip strength measurement, and self-rated habitual adjusted activity score with Human Activity Profile questionnaire. Adjusted general linear models were used to analyze association of 25-hydroxyvitamin D levels with test results. RESULTS: Serum 25-hydroxyvitamin D concentration was 73.1 ± 35.4 nmol/L in dialysis patients and 64.6 ± 22 nmol/L in controls (p = 0.12). When adjusted for age, sex, body height, spontaneous gait speed, and dialysis dependence, 25-hydroxyitamin D was significantly positively associated with 6-minute walk test result, explaining 5% of variability in walked distance (B = 0.6 m/nmol/L, p = 0.008) and 12% of variability in adjusted activity score (B = 0.1 point/nmol/L, p < 0.001). There was no significant association with handgrip strength or sit-to-stand performance in adjusted models. CONCLUSIONS: Serum 25-hydroxyvitamin D levels are significantly positively associated with submaximal aerobic physical performance and habitual activity level in dialysis patients.
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The predictive value of urinary vascular endothelial growth factor (VEGF) on worsening kidney function in proteinuric chronic kidney disease.

OBJECTIVES: To evaluate the role of urinary vascular endothelial growth factor (VEGF) as an early predictor of chronic kidney disease (CKD) progression in patients with glomerular diseases. METHODS: We prospectively included patients with proteinuria and CKD grade 1 - 5 due to glomerular disease at the time of kidney biopsy. At baseline, we collected demographics, comorbidities, smoking history, serum creatinine (sCr), proteinuria, and urinary VEGF in collected 24-hour urine. The primary outcome was a 50% increase in sCr at last follow-up. Binary regression was used to explore the impact of urinary biomarkers adjusted for baseline patient characteristics on the outcome. RESULTS: From July 2011 to September 2012 we included 49 patients aged 45.2 ± 14.8 years, 43% female, with different glomerular diseases. We followed them for 29 ± 11 months. Twelve out of 49 (22%) patients met the primary outcome. The patients with a 50% increase in sCr at last follow-up had a significantly higher baseline sCr (193 ± 101 vs. 127 ± 84; p = 0.014) and higher urinary VEGF/creatinine in 24-hour urine (7.7 ± 6.4 vs. 3.0 ± 4.0; p = 0.005). When we added both sCr and urinary VEGF/creatinine to the binary regression model, the correlation with baseline sCr was not significant (OR 1.01; 95% CI 1.00 - 1.01; p = 0.184), while urinary VEGF/creatinine remained significant (OR 1.18; 95% CI 1.04 - 1.35; p = 0.008). Baseline patient characteristics, such as age, gender, body mass index, sCr, proteinuria, smoking status, histopathologic diagnosis, concomitant arterial hypertension, and time to last follow-up did not influence the primary outcome. CONCLUSIONS: The urinary VEGF/creatinine ratio in 24-hour urine seems to independently predict worsening of chronic kidney disease in patients with glomerular diseases.
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The impact of gene polymorphisms in angiotensin receptor 1 and aldosterone synthase in peritoneal dialysis patients.

AIM: Longevity of peritoneal membrane is an important issue in patients treated with peritoneal dialysis (PD). In our study, we studied the impact of angiotensin receptor 1 (AGT R1) and aldosterone synthase (CYP11B2) gene polymorphism on peritoneal concentrations of interleukin-6 (PI-IL-6), vascular endothelial growth factor (PI-VEGF), plasminogen activator inhibitor-1 (PI-PAI-1), transforming growth factor-ß (PI-TGF-ß), and cancer antigen-125 (PI-CA-125) as known markers of peritoneal fibrosis. The single nucleotide polymorphism rs5186 (A1166C) in AGT R1 gene is located in 3' untranslated region (UTR) of the gene, while polymorphism rs1799998 (T -344 C) in CYP11B2 gene is located in the promoter region of the gene. METHODS: We compared marker concentrations in patients with genotype DD vs. Dd and dd for AGT R1 and patients with genotype HH vs. Hh and hh for CYP11B2. RESULTS: The results show that polymorphism of CYP11B2 gene is associated with serum concentration of aldosterone. Patients with genotype HH had statistically significantly lower serum concentration of aldosterone (p = 0.04). These patients also showed a trend to a lower rate of production of I-IL-6 (p = 0.07), which correlated with lower concentrations of PAI-1 (p = 0.002) and VEGF (p = 0.005). AGT R1 gene polymorphism did not show any association with studied variables. CONCLUSIONS: Our findings suggest the possibility of genetic predisposition for development of peritoneal fibrosis that could be important for identification of patients with an "unfavorable" genotype, which could lead to customized prescription of appropriate therapy and personalized patient management.
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Tubular urinary indexes reliably distinguish between primary tubulointerstitial and primary glomerular diseases in patients referred for kidney biopsy.

AIMS: Kidney biopsy remains the gold standard for accurately diagnosing renal diseases. Urinalysis and assessment of renal function are the cornerstones for assessment of patients prior to biopsy. There is significant overlap in the results of routine urine parameters (proteinuria, erythrocyturia, leukocyturia) among different kidney diseases, which hinders the possibility of adequately estimating disease etiology prior to the biopsy. The aim of our study was to assess whether diverse markers of glomerular and tubular proteinuria - urinary albumin, IgG, α-1-microglobulin (α-1-m) and N-acetyl-ß-D-glucosaminidase (NAG) - are capable of distinguishing between patients with primary tubulointerstitial (TID) and primary glomerular disease (GLOM). METHODS: Our study is a retrospective, single-center, consecutive case series of patients referred for kidney biopsy. We analyzed routine urinalysis results performed on a second morning urine sample immediately prior to the biopsy. RESULTS: Patients with TID had significantly higher values of α-1-m and NAG, with lower values of albumin and IgG in the urine compared to patients with GLOM. Three tubular urinary indexes had high sensitivity and specificity for distinguishing TID from GLOM: NAG/albumin, α-1-m/proteinuria, and α-1-m/albumin, with the highest values in the latter index (96.6% and 98.2%, respectively, cut-off point ≥ 0.33). CONCLUSIONS: Prior to kidney biopsy, tubular urinary indexes may present a valuable tool in distinguishing patients with TID from patients with GLOM.
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Isolated Effects of Renal Failure, Anthropometric Indices, and Serum Total Iron-Binding Capacity as Determinants of Muscle Performance in Hemodialysis Patients.

OBJECTIVE: We quantified the isolated impact of end-stage renal disease (ESRD) on physical performance under contemporary hemodialysis treatment independent of comorbid diseases, characterized principal anthropometric components, and adjusted for their influence and compared associations of C-reactive protein (CRP), albumin, and serum total iron-binding capacity (TIBC) with muscle function. DESIGN: A case-control cross-sectional study. SETTING: University medical hospital and outpatient hemodialysis units. SUBJECTS: Ninety prevalent hemodialysis patients without important comorbidities and 140 controls. MAIN OUTCOME MEASURES: Handgrip strength (HGS) and 10-repetition sit-to-stand time (STS-10). RESULTS: Principal component analysis revealed 3 representative anthropometric measures to be included in explanatory models of muscle performance additional to body height: lean body mass, fat mass, and joint size. Controlling for these covariates, age, sex, and residual comorbidity, ESRD was associated with a modest 7.5% reduction in HGS (B = -2.57 kg; 95% confidence interval: -4.81 to -0.39; P = .005; model R(2) 0.74) and a relatively larger prolongation of 27% in STS-10 time (B = 4s; 95% confidence interval: 2.61 to 5.4; P < .001; model R(2) 0.53). Lean body mass and height significantly predicted both tests, fat mass, and wrist size predicted HGS. In the subgroup of dialysis patients, only TIBC showed a significant association with HGS independently from age, sex, wrist size, whereas CRP and albumin did not. STS-10 time was not associated with any of these biomarkers. Results remained stable in sensitivity analyses excluding patients with reported chronic regional motor difficulties and aches. CONCLUSIONS: ESRD with contemporary hemodialysis therapy has a relatively modest negative comorbidity-free association with HGS and a larger effect on STS-10 lower extremity performance. Nonmodifiable anthropometric indices (body height and for HGS wrist size) have a significant independent impact and should be consistently adjusted for in future studies. In low-comorbidity dialysis patients, TIBC is a superior predictor of HGS compared with albumin and CRP.

Serum with phospholipase A2 receptor autoantibodies interferes with podocyte adhesion to collagen.

BACKGROUND: The majority of sera from patients with primary membranous nephropathy have autoantibodies against the M-type phospholipase A2 receptor (PLA2R) which is expressed on human podocytes. The rabbit variant of PLA2R attaches to collagen type IV via the fibronectin type II domain, which is also present in the human variant of PLA2R. DESIGN: To assess whether the human PLA2R variant is also involved in attachment to collagen type IV, we conducted a cell adhesion assay on a collagen-coated surface using PLA2R-transfected and mock-transfected human embryonic kidney (HEK) cells. To test the hypothesis that sera from patients containing anti-PLA2R antibodies interfere with the adhesion of podocytes to collagen, we performed cell adhesion assays on a collagen type IV-coated surface using positive and negative serum samples from patients and cultured human podocytes in vitro expressing PLA2R. RESULTS: The HEK cell adhesion assay confirmed an enhanced attachment of PLA2R-transfected cells to collagen type IV. We confirmed diminished podocyte adhesion in the presence of serum with anti-PLA2R antibodies. The concentration of anti-PLA2R antibodies correlated with proteinuria and to the degree of diminished adhesion of podocytes. CONCLUSIONS: We demonstrated that serum of patients containing autoantibodies directed to PLA2R interferes with the ability of podocytes to attach to collagen type IV in vitro, providing evidence of a serum soluble pathogenic factor interfering with podocyte adhesion in membranous nephropathy.

Non-inferiority of creatinine excretion rate to urinary L-FABP and NGAL as predictors of early renal allograft function.

BACKGROUND: We evaluated accuracy of urinary liver type fatty acid-binding protein (L-FABP) for prediction of early allograft function and compared it to neutrophil gelatinase associated lipocalin (NGAL), diuresis and urinary creatinine excretion rate (UCr). METHODS: Urine samples from 71 consecutive patients were taken 4, 10, 24 and 48 h after transplantation. We classified recipients into two groups: immediate graft function (IGF), with more than 70% reduction of serum Cr at 7th day post-transplant, and delayed graft function (DGF)/slow graft function (SGF) group (DGF--the need for hemodialysis procedure in the first week, SGF--less than 70% reduction of serum Cr in the first week). RESULTS: Thirty-one recipients had IGF and 40 had DGF/SGF. L-FABP was only useful 48 h post-transplant with ROC AUC of 0.85 (95% C.I. 0.74-0.92); NGAL 24 h post-transplant had ROC AUC of 0.82 (0.7-0.91). Sensitivity, specificity, PPV and NPV for prediction of DGF/SGF with L-FABP > 9.5 mg/mmol Cr and NGAL > 33.1 µg/mmol Cr were: 86, 80, 83 and 83% (L-FABP), and 68, 93, 91, and 73% (NGAL). The difference in urine output between the groups was largest 4 h post-transplant (p = 0.001), later on the difference diminished. There were no significant differences in ROC AUC between L-FABP at 48 h, NGAL at 24 h, urine output at 4 h and UCr excretion rate at 10 h post-transplant. UCr < 0.56 mmol/h 10 h post-transplant predicted DGF/SGF with 94% sensitivity, 84% specificity, 89% PPV and 91% NPV, ROC AUC was 0.9. Classification tree with urine output 4 h and UCr 10 h post-transplant accurately predicted 89% of outcomes. When L-FABP or NGAL were added, the prediction was accurate in 92 or 90%, respectively. CONCLUSIONS: L-FABP is comparable to NGAL for prediction of first week allograft function, however UCr and diuresis were non-inferior.

Randomized Controlled Trial of Intradialytic Cognitive and Physical Training to Enhance Functional Capacity.

Introduction: Hemodialysis (HD) patients frequently experience cognitive and physical impairments due to various factors, including age, comorbidities, and the demanding nature of the treatment. This study explores the impact of a 12 week integrated cognitive and physical training program on the functional capacity of patients on HD. Methods: A single blind, randomized controlled trial was conducted with 44 patients on HD. Participants were divided into an experimental (EXP) group that received a combined intervention of intradialytic cycling and cognitive training, and a control (CON) group receiving standard HD treatment. The Trail Making Test (TMT), Timed Up and Go (TUG) test, and TUG dual task test (TUG-dual) were conducted before and after the intervention. Results: The EXP group demonstrated significant improvements in cognitive function, as evidenced by decreased TMT completion times (TMTA: -3.6 s, P = 0.006; TMTB: -14.0 s, P < 0.001; TMTB - TMTA: -10.4 s, P = 0.004). In contrast, the CON group experienced a significant decline in TMTA and TMTB. In addition, the EXP group exhibited enhanced mobility, with reduced TUG completion times (-0.8 s, P < 0.001) and improved cognitive motor performance in the TUG-dual (-1.0 s, P < 0.001), whereas the CON group showed no significant changes. Conclusion: This study demonstrates that a 12 week combined cognitive and physical training program during HD sessions significantly enhances cognitive function and mobility in patients on HD. These findings suggest that integrated interventions can mitigate functional declines in this population and improve their overall quality of life. Further research with larger samples and active control groups is warranted to confirm and expand upon these promising results.

Prevalence of Impaired Physical Mobility in Dialysis Patients: A Single-Centre Cross-Sectional Study.

Impaired physical mobility in hemodialysis (HD) patients is considered an important modifiable risk factor of increased all-cause morbidity and mortality. To our knowledge, no study to date has determined the overall burden of limited physical mobility in prevalent HD patients. The aim of this research is to investigate impaired physical mobility and its clinical correlates. We conducted a cross-sectional observational study in all patients of the Centre for Acute and Complicated Dialysis at the University Medical Centre of Ljubljana, where the most complex patients receive HD on average three times per week. The data were collected through interviews based on a prepared questionnaire and medical history review. A total of 205 patients were included in this study (63.9 ± 15.4 years). Sixty percent (122/205) of the patients had little or no physical mobility impairment, and others were categorized with a minor or severe mobility limitation. A minor mobility impairment was found in 21% (43/205) of patients: 10 patients (5%) used a mobility aid in the form of a crutch, 9 patients (4%) were dependent on two crutches or a walker, and 24 patients (12%) were temporarily dependent on the assistance of a third person. Severe mobility limitations were observed in 22% (40/205) of patients, ranging from being confined to bed (19/205, 9%), confined to bed but able to perform some movements (19/205, 9%), and ambulatory but dependent on the assistance of a third person for locomotion (2/205, 1%). The most common causes of the limitation of mobility were neurological (19/40, 47.5%), cardiovascular (9/40, 22.5%), musculoskeletal (8/40, 20%), and other causes (4/40, 10%). A significant, moderate positive correlation was observed between mobility problems and the age of the participants (r = 0.36, p < 0.001), while a significant, small positive correlation was obtained between the mobility problems and C-reactive protein (r = 0.15, p = 0.044). Moreover, mobility problems had a small but significant negative correlation with albumin levels (r = -0.15, p = 0.042). When controlling for age, results yield no significant correlations, and, in regression analysis, only the age (p < 0.001) and male gender (p = 0.007) of the participants were independent predictors of mobility impairment. We conclude that impaired mobility has a high overall prevalence among chronic HD patients. Strategies to prevent and improve mobility limitations are strongly needed.

Cognitive behavioral therapy for lifestyle changes in patients with obesity and type 2 diabetes: a systematic review and meta-analysis.

The aim of this systematic review and meta-analysis was to examine the contribution of cognitive behavioral therapy (CBT) to the implementation of lifestyle changes, considering health-related and behavioral outcomes. A systematic literature review was performed using multiple databases (PsycInfo, PubMed and MEDLINE). The inclusion criteria comprised randomised controlled trials of CBT for lifestyle changes in patients with obesity and/or type 2 diabetes. The quality of study reporting was assessed with the revised Cochrane Collaboration's risk of bias tool. A meta-analysis was conducted on studies with appropriate outcomes. Nine randomised controlled trials, with a total sample size of 902 participants, met the inclusion criteria. The meta-analysis has shown a medium, significant effect size of CBT interventions for weight loss and weight maintenance, and a low, non-significant effect size of CBT interventions for reducing glycated hemoglobin (HbA1c) levels. A separate, combined, meta-analysis for all nine calculated effect sizes has yielded a medium and significant overall effect size for the model. Our review of the studies about the effectiveness of CBT in implementing lifestyle changes has, in comparison to usual control groups, proven the efficacy of CBT interventions in implementing lifestyle changes, especially for weight loss and weight maintenance.

Cognitive behavioral therapy for managing obesity in patients with chronic kidney disease: Study protocol for a randomized controlled trial.

Obesity is one of the main risk factors for progression of chronic kidney disease (CKD). Weight loss interventions have limited efficacy in patients with pre-dialysis CKD. Our objective is to test the efficacy of a cognitive behavioral therapy program for obesity management in patients with CKD. We will conduct a randomized controlled intervention trial to evaluate the effects of cognitive behavioral therapy for obesity on weight loss, change in proteinuria, weight maintenance, quality of life, depression symptoms, and anxiety symptoms in patients with CKD. The duration of the intervention will be 16 weeks. The primary study outcomes will be body mass index (BMI) and proteinuria. CKD patients will be randomized into two groups: an intervention group with cognitive behavioral therapy, sessions with a dietitian and a kinesiologist, and a control group with sessions with a dietitian and a kinesiologist, without cognitive behavioral therapy. Study outcomes will be assessed at baseline, immediately after the 16-week intervention, 3 months after the end of the intervention, and 12 months after the end of the intervention. This study will be the first to evaluate the efficacy of cognitive behavioral therapy for obesity in patients with CKD. We expect that our results will contribute to new ways of non-pharmacological treatment of CKD. Clinical trial registration: ClinicalTrials.Gov, NCT05927337.

Effects of Intradialytic Cognitive and Physical Exercise Training on Cognitive and Physical Abilities in Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial.

The prevalence of cognitive impairment in hemodialysis (HD) patients is extremely high. Despite the well-documented benefits of interventions on cognitive function, there is a widespread call for effective strategies that will show the long-term consequences in patients undergoing dialysis. The aim of this research protocol was to investigate the effect of cognitive training combined with physical exercise on cognitive function, physical performance, and frailty indicators in the HD population. We will conduct a randomized controlled intervention trial to examine the effects of a combined non-pharmacological intervention in the form of intradialytic physical exercise and intradialytic cognitive training on cognitive function, indicators of frailty, and physical performance measures in HD patients. The group of patients receiving the study intervention will be compared to the control group receiving standard HD care. The duration of the intervention will be 12 weeks. We will use sensitive instruments (cognitive domain tests) to assess cognitive functions. The primary outcome of the study at 12 weeks will be performance on the Alertness subtest of the computerized Test of Attentional Performance. Secondary study outcomes are: Performance in other domains of cognitive function (executive function, psychomotor speed, information processing efficiency, working memory, and attention), physical fitness (10 repetition sit-to-stand test, timed up and go test, handgrip strength test, spontaneous gait speed, and stork balance test), and assessment of frailty (Edmonton Frail Scale). Study outcomes will be assessed at baseline, immediately after the 12-week intervention, and 6 months after the end of the study without specific further intervention (retention effect assessment). This study will be among the first to test the synergistic effects of a uniquely designed physical exercise and cognitive training intervention on functional status in HD patients. We believe our results will contribute to dementia prevention research by demonstrating the long-term efficacy of our combined intervention. Clinical Trial Registration: ClinicalTrials.Gov, NCT05150444.

Physical exercise and cognitive training interventions to improve cognition in hemodialysis patients: A systematic review.

Introduction: Patients with chronic kidney disease treated with hemodialysis (HD) have lower cognitive abilities compared to the age-matched healthy population. Recently, physical exercise and cognitive training have been presented as possible interventions to improve cognitive abilities both in the general population and in patients with chronic diseases. To date, there is no general overview of the current knowledge on how these interventions affect cognitive abilities in HD patients and what tests are used to measure these effects. Methods: Three electronic databases were searched for randomized controlled studies of physical exercise or cognitive training interventions that examined effects on cognitive abilities/performance in HD patients. Results: Six articles were included. All included studies used physical exercise as an intervention, with one study also including tablet-based cognitive training. Four studies included an intradialytic approach and two included a home-based intervention. Intervention lasted. A significant intervention effect was observed in three studies compared with the control condition. Conclusion: The present review suggests that physical exercise might improve or at least not worsen cognitive performance in HD patients, whereas the effect of cognitive training has not yet been adequately studied. There is a need for more sensitive and specific cognitive tests to adequately measure the effects of interventions in the HD population.

Whole-Food Plant-Based Lifestyle Program and Decreased Obesity.

Failure of weight-loss programs is high. We evaluated a whole-food plant-based (WFPB) lifestyle program. We investigated the obesity indices of 151 healthy adults who were on our ongoing, community-based program for the short (0.5 to ≤2 years), medium (2 to ≤5 years), or long term (5 to 10 years). Body composition indices were measured by medically approved bioimpedance. Body composition changes were favorable for all 3 groups and both genders. There were no differences in body composition between the males for all 3 groups, while there were lower body mass (BM), body mass index (BMI), and muscle mass in females on long-term versus short-term programs. All participants experienced a decrease in BMI (-2.5 kg/m2), BM (-7.1 kg), and body fat percentage (-6.4%; P < .001 for all). The reductions for those with a baseline BMI of obese, overweight, and normal were -5.6, -2.4, and -0.9 kg/m2 for BMI, -16.1, -7.1, and -2.5 kg for total BM, and -9.5%, -6.6%, and -4.8% for body fat percentage (baseline vs current; P < .001 for all). A total of 86% of parents of underage children introduced the WFPB lifestyle to children. Our WFPB lifestyle program provides a long-term reversal of obesity.

Medium Cut-Off Dialysis Membrane and Dietary Fiber Effects on Inflammation and Protein-Bound Uremic Toxins: A Systematic Review and Protocol for an Interventional Study.

The aim of this systematic review is to investigate the effects of the use of a medium cut-off membrane (MCO) and dietary fiber on the concentration of protein-bound uremic toxins (PBUTs) and inflammatory markers in hemodialysis (HD) patients. Of 11,397 papers originally found, eight met the criteria of randomized controlled trial design. No study examined the effects of MCO membranes on PBUTs. Three studies examined the reduction in inflammatory markers with MCO membranes compared to high-flux HD membranes and showed no significant differences. Five studies of dietary fiber supplementation showed an inconclusive positive effect on PBUT levels and a significant positive effect on the reduction in inflammatory markers (interleukin-6 reduction: standardized difference in means -1.18; 95% confidence interval -1.45 to -0.9 for dietary fiber supplementation vs. control; p < 0.001). To date, no study has combined the use of an MCO membrane and fiber supplementation to reduce PBUT levels and inflammation with online hemodiafiltration as a comparator. A rationale and protocol for an interventional trial using a combination of MCO membrane dialysis and fiber supplementation to lower inflammatory markers and PBUT concentrations are presented.