Physical Activity Adherence Rates in Older Kidney Transplant Recipients: A Pilot Randomized Controlled Trial

Abstract Daily walking activities are associated with improving cardiovascular and well-being in older kidney transplant recipients. Multicomponent interventions using technology and goal setting holds promise for sustaining daily walking activity among this population. The purpose of this randomized controlled trial pilot study was to evaluate the feasibility of a multicomponent intervention called SystemCHANGE™ + activity tracker for daily walking activity in older (age 60 and over) kidney recipients from baseline to 12 months. The intervention group implement a personal-system solution and wore a mobile activity tracker daily for 12 months. The attention-control group received educational information on healthy living as a transplant recipient and was asked to wear a mobile activity tracker daily for 12 months. Participants were randomized 1:1 to the intervention or control group. The sample consisted of 53 participants (n = 27 intervention, and n = 26 control). At the 12-month follow-up visit, the total study attrition rate was 23%. The adherence rates at 12 months were 96.5% in the intervention group and 80.8% in the attention- control group. The intervention group increased their steps from baseline to 12 months by 334 steps per day. The attention-control group demonstrated a decrease in steps by 563 steps per day. We found a mean difference of 1041± 2440 (Cohen’s d = 0.43) in daily steps between the groups from baseline to 12 months. The data suggests SystemCHANGE™ in combination with activity trackers may be feasible for older kidney transplant recipients to enhance and sustain physical activity with daily walking.

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INCREASING PHYSICAL ACTIVITY POST-KIDNEY TRANSPLANT: A PILOT RANDOMIZED CONTROLLED TRIAL

Innovation in Aging ◽

10.1093/geroni/igz038.1919 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S521-S521

Author(s):

Tara O’Brien ◽

Cynthia Russell ◽

Donna Hathaway

Keyword(s):

Physical Activity ◽

Kidney Transplant ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Randomized Controlled ◽

Activity Trackers ◽

Pilot Randomized Controlled Trial

Abstract Older kidney transplant recipients are at risk for graft failure and death due to lack of physical activity. Physical activity after transplant is the most modifiable non-pharmacological factor for improving physical function. One personal system intervention called, SystemCHANGE™ in combination with activity trackers, holds promise for increasing physical activity among this population. The purpose of this pilot randomized controlled trial was to evaluate the efficacy of SystemCHANGE™ on increasing average daily steps in older (age 60 and over) kidney transplant recipients from baseline to 6 months. The intervention group met monthly to implement a successful personal system solution based on their daily routines and step-data collected from the activity tracker. The control group received monthly educational information on healthy living with a transplant. Participants were randomized 1:1 to the intervention or control group. The sample consisted of 31 participants (n = 15 intervention, and n = 16 control). No significant differences were found at baseline among the groups for demographics, self-efficacy and health outcomes (blood pressure, weight, waist circumference, 6 minute Walk Test). However, the intervention group had greater increase in the average daily steps from baseline to 6 months (mean ± SD: 1511 ± 2320) as compared to the control group (181 ± 2419). The between-group difference was of medium effect size (d = .56).The data suggests SystemCHANGE™ in combination with activity trackers may be feasible for older kidney transplant recipients to enhance daily steps.

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A Pilot Randomized Controlled Trial Using SystemCHANGE™ Approach to Increase Physical Activity in Older Kidney Transplant Recipients

Progress in Transplantation ◽

10.1177/1526924820958148 ◽

2020 ◽

Vol 30 (4) ◽

pp. 306-314

Author(s):

Tara O’Brien ◽

Cynthia L. Russell ◽

Alai Tan ◽

Lorraine Mion ◽

Karen Rose ◽

...

Keyword(s):

Physical Activity ◽

Heart Rate ◽

Health Outcomes ◽

Kidney Transplant ◽

Intervention Group ◽

Control Group ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Activity Tracker ◽

Kidney Recipients

Background: Cardiovascular disease is the leading cause of death in kidney transplant recipients. Physical activity after transplant is the most modifiable nonpharmacological factor for improving cardiovascular outcomes. Few studies have tested walking interventions to enhance daily steps and health outcomes in older kidney recipients. Methods: Using a pilot feasibility randomized clinical trial design, we tested the feasibility and efficacy of a 6-month SystemCHANGE™ (Change Habits by Applying New Goals and Experience) + Activity Tracker intervention for recruitment, retention, daily steps, and health outcomes (blood pressure, heart rate, body mass index, waist circumference, and physical function). The SystemCHANGE™ + Activity Tracker intervention taught participants to use a multicomponent intervention that connects person-centered systems solutions combined with visual feedback from a mobile activity tracker to achieve daily step goals. Results: Fifty-three participants (mean age 65 years, 66% male, and 57% white) participated with 27 in the intervention and 26 in the control group. The study protocol was feasible to deliver with high adherence to the protocol in both groups. The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283, P = .03) compared to the control group. The secondary outcome of heart rate decreased for the intervention group (baseline [mean] 74.4+ 10.8 [standard deviation, SD;] vs 6 months [mean] 67.6+ 11.3 [SD]; P = .002) compared to the control group (baseline [mean] 70.67+ 10.4 [SD]; vs 6 months [mean] 70.2 + 11.1 [SD]; P = .83). Conclusions: SystemCHANGE™ + Activity Tracker intervention appears to be feasible and efficacious for increasing daily steps in older kidney recipients.

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Consumption of Dietary Guidelines for Americans Types and Amounts of Vegetables Increases Subjective Happiness: A Randomized Controlled Trial

Current Developments in Nutrition ◽

10.1093/cdn/nzab056_004 ◽

2021 ◽

Vol 5 (Supplement_2) ◽

pp. 1266-1266

Author(s):

Angela De Leon ◽

Lisa Jahns ◽

James Roemmich ◽

Shanon Casperson

Keyword(s):

Vegetable Consumption ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Dietary Guidelines ◽

Attention Control ◽

Control Group ◽

Subjective Happiness ◽

Dietary Guidelines For Americans ◽

Attention Control Group

Abstract Objectives The health benefits of diets rich in fruits and vegetables (FV) are well established and form the basis of the Dietary Guidelines for Americans (DGA). Furthermore, FV consumption may also exert a positive effect on psychological well-being. This study aimed to assess changes in global subjective happiness when consuming DGA recommended types and amounts of vegetables. It was hypothesized that increased vegetable consumption would increase happiness. Methods This study investigated secondary outcomes of a randomized, parallel, non-blinded controlled trial with a 1:1 allocation ratio to a provided vegetable intervention or attention control group. Men and women aged 18–65 yr, body mass index ≥ 25 kg/m,2 with low habitual vegetable consumption (<1 serving/day) were recruited for this community-based study. The vegetable intervention consisted of an 8-week feeding phase during which participants were provided with vegetables in DGA recommended types and amounts. The attention control group was not provided vegetables but completed the same testing schedule as the vegetable intervention group. The Subjective Happiness Scale (SHS) was used to assess individual perceived happiness before and after the intervention. SHS scores were analyzed using a mixed model analysis of variance both with and without baseline SHS scores as a covariate. Results A significant interaction between treatment and visit (P = 0.005) revealed greater happiness at week 8 than at baseline in the vegetable intervention group but no change in the attention control group. When adjusted for baseline scores, a significant effect of treatment (P = 0.005) was found with greater happiness scores in the vegetable intervention group compared to the attention control group post intervention (P < 0.001). Conclusions Greater subjective happiness was observed after increasing vegetable consumption to meet DGA recommendations. Funding Sources USDA-ARS #5450–51,530-057–00D.

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Using informatics and mobile health to improve medication safety monitoring in kidney transplant recipients

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxz115 ◽

2019 ◽

Vol 76 (15) ◽

pp. 1143-1149 ◽

Cited By ~ 3

Author(s):

David J Taber ◽

Nicole A Pilch ◽

John W McGillicuddy ◽

Caitlin Mardis ◽

Frank Treiber ◽

...

Keyword(s):

Kidney Transplant ◽

Medication Safety ◽

Retention Rate ◽

Controlled Trial ◽

Intervention Group ◽

Safety Monitoring ◽

Controlled Clinical Trial ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Randomized Controlled

Abstract Purpose The development, testing, and preliminary validation of a technology-enabled, pharmacist-led intervention aimed at improving medication safety and outcomes in kidney transplant recipients are described. Summary Medication safety issues, encompassing medication errors (MEs), medication nonadherence, and adverse drug events (ADEs), are a predominant cause of poor outcomes after kidney transplantation. However, a limited number of clinical trials assessing the effectiveness of technology in improving medication safety and outcomes in transplant recipients have been conducted. Through an iterative, evidence-based approach, a technology-enabled intervention aimed at improving posttransplant medication safety outcomes was developed, tested, and preliminarily validated. Early acceptability and feasibility results from a prospective, randomized controlled trial assessing the effectiveness of this system are reported here. Of the 120 patients enrolled into the trial at the time of writing, 60 were randomly assigned to receive the intervention. At a mean ± S.D. follow-up of 5.8 ± 4.0 months, there were 2 patient dropouts in the intervention group, resulting in a retention rate of 98%, which was higher than the expected 90% retention rate. Conclusion The development and deployment of a comprehensive medication safety monitoring dashboard for kidney transplant recipients is feasible and acceptable to patients in the current healthcare environment. An ongoing randomized controlled clinical trial is assessing whether such a system reduces MEs and ADRs, leading to improved patient outcomes.

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Impact of a pharmacist-led, mHealth-based intervention on tacrolimus trough variability in kidney transplant recipients: A report from the TRANSAFE Rx randomized controlled trial

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxab157 ◽

2021 ◽

Author(s):

James N Fleming ◽

M Gebregziabher ◽

A Posadas ◽

Z Su ◽

J W McGillicuddy ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Kidney Transplant ◽

Controlled Trial ◽

Intervention Group ◽

Complex Problem ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Ischemic Time ◽

Randomized Controlled ◽

Allograft Loss

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Nonadherence is a leading cause of death-censored allograft loss in kidney transplant recipients. Strong associations have tied tacrolimus intrapatient variability (IPV) to degree of nonadherence and high tacrolimus IPV to clinical endpoints such as rejection and allograft loss. Nonadherence is a dynamic, complex problem best targeted by multidimensional interventions, including mobile health (mHealth) technologies. Methods This was a secondary planned analysis of a 12-month, parallel, 2-arm, semiblind, 1:1 randomized controlled trial involving 136 adult kidney transplant recipients. The primary aims of the TRANSAFE Rx study were to assess the efficacy of a pharmacist-led, mHealth-based intervention in improving medication safety and health outcomes for kidney transplant recipients as compared to usual care. Results Patients were randomized equally to 68 patients per arm. The intervention arm demonstrated a statistically significant decrease in tacrolimus IPV over time as compared to the control arm (P = 0.0133). When analyzing a clinical goal of tacrolimus IPV of less than 30%, the 2 groups were comparable at baseline (P = 0.765), but significantly more patients in the intervention group met this criterion at month 12 (P = 0.033). In multivariable modeling, variables that independently impacted tacrolimus IPV included time, treatment effect, age, and warm ischemic time. Conclusion This secondary planned analysis of an mHealth-based, pharmacist-led intervention demonstrated an association between the active intervention in the trial and improved tacrolimus IPV. Further prospective studies are required to confirm the mutability of tacrolimus IPV and impact of reducing tacrolimus IPV on long-term clinical outcomes.

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CONTROLLED TRIAL OF IL2R ANTIBODY BASILIXIMAB (SIMULECT) VS LOW DOSE OKT3 IN CADAVER KIDNEY TRANSPLANT RECIPIENTS.

Transplantation Journal ◽

10.1097/00007890-200004271-00164 ◽

2000 ◽

Vol 69 (Supplement) ◽

pp. S156 ◽

Cited By ~ 6

Author(s):

Hamid Shidban ◽

M. Sabawi ◽

S. Aswad ◽

G. Chambers ◽

I. Castillon ◽

...

Keyword(s):

Kidney Transplant ◽

Low Dose ◽

Controlled Trial ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Cadaver Kidney

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Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05253-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aziza Ajlan ◽

Hassan Aleid ◽

Tariq Zulfiquar Ali ◽

Hala Joharji ◽

Khalid Almeshari ◽

...

Keyword(s):

Kidney Transplant ◽

De Novo ◽

Controlled Trial ◽

Controlled Clinical Trial ◽

First Year ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Double Blind ◽

Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

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Alendronate as an Effective Treatment for Bone Loss and Vascular Calcification in Kidney Transplant Recipients

Journal of Transplantation ◽

10.1155/2014/269613 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 14

Author(s):

Masanori Okamoto ◽

Shintaro Yamanaka ◽

Wataru Yoshimoto ◽

Takashi Shigematsu

Keyword(s):

Bone Loss ◽

Effective Treatment ◽

Kidney Transplant ◽

Vascular Calcification ◽

Secondary Osteoporosis ◽

Control Group ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Mineral Density ◽

Group A

Kidney transplant recipients develop secondary osteoporosis induced by immunosuppressive medication, with a high risk of fracture, and abdominal aortic calcification (AC) is a known predictor of cardiovascular mortality. In this study of 12 stable kidney recipients, we estimated the preventive effect of bisphosphonate treatment on bone loss and progression of AC. We randomly divided the subjects into a treatment group with alendronate (group A: 5 subjects) and a control group (group C: 7 subjects). Group A patients received 35 mg/week of alendronate over 24 months, while group C patients were not administered with any bisphosphonates. Two major endpoints were established: (1) the time-dependent change in bone mineral density (BMD) estimated with DEXA and (2) progression of abdominal AC, calculated twice as an index (ACI) using computed tomography data. Over the 2-year study period, group A patients showed significantly increased BMD of 1.86 ± 0.85% (P=0.015versus baseline), and almost complete inhibition of ACI progression (38.2 ± 24.2% to 39.6 ± 24.3%), but group C patients showed a decrease in BMD decline with bone loss and progression of ACI (32.8 ± 25.0% to 37.8 ± 29.2%,P=0.061). In conclusion, alendronate therapy was an effective treatment in kidney transplant recipients for secondary osteoporosis and vascular calcification as ectopic calcification. This clinical trial is registered with number JMA-IIA00155 of JMACCT CTR.

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A Prospective Controlled Trial to Evaluate Safety and Efficacy of in vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-Mismatched Living Donor Kidney Transplant Recipients (Trex001)

Frontiers in Medicine ◽

10.3389/fmed.2020.634260 ◽

2021 ◽

Vol 7 ◽

Author(s):

Rainer Oberbauer ◽

Matthias Edinger ◽

Gabriela Berlakovich ◽

Peter Kalhs ◽

Nina Worel ◽

...

Keyword(s):

Bone Marrow ◽

Kidney Transplant ◽

Graft Function ◽

Control Group ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Post Transplant ◽

Donor Bone Marrow ◽

Living Donor Kidney Transplant

Background: The induction of donor-specific immunological tolerance could improve outcome after kidney transplantation. However, no tolerance protocol is available for routine clinical use. Chimerism-based regimens hold promise, but their widespread application is impeded in part by unresolved safety issues. This study tests the hypothesis that therapy with polyclonal recipient regulatory T cells (Tregs) and anti-IL6R (tocilizumab) leads to transient chimerism and achieves pro-tolerogenic immunomodulation in kidney transplant recipients also receiving donor bone marrow (BM) without myelosuppressive conditioning of the recipient.Methods/design: A prospective, open-label, controlled, single-center, phase I/IIa academic study is performed in HLA-mismatched living donor kidney transplant recipients.Study group: Recipients of the study group receive in vitro expanded recipient Tregs and a donor bone marrow cell infusion within 3 days after transplantation and tocilizumab for the first 3 weeks post-transplant. In addition they are treated with thymoglobulin, belatacept, sirolimus, and steroids as immunosuppression. Starting 6 months post-transplant, sirolimus and steroids are withdrawn in a step-wise manner in stable patients.Control group: Recipients of the control group are treated with thymoglobulin, belatacept, sirolimus, and steroids as immunosuppression. Co-primary endpoints of safety (impaired graft function [eGFR <35 mL/min/1.73 m2], graft-vs.-host disease or patient death by 12 months) and efficacy (total leukocyte donor chimerism within 28 days post-transplant) are assessed. Secondary endpoints include frequency of biopsy-proven acute rejection episodes and subclinical rejection episodes on surveillance biopsies, assessment of kidney graft function, and the evaluation whether the study protocol leads to detectable changes in the immune system indicative of pro-tolerogenic immune modulation.Discussion: The results of this trial will provide evidence whether treatment with recipient Tregs and donor BM is feasible, safe and efficacious in leading to transient chimerism. If successful, this combination cell therapy has the potential to become a novel treatment option for immunomodulation in organ transplantation without the toxicities associated with myelosuppressive recipient conditioning.Trial registration: European Clinical Trials Database EudraCT Nr 2018-003142-16 and clinicaltrials.gov NCT03867617.

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THE STATE OF THE CARDIOVASCULAR SYSTEM IN CHILDREN OF KIDNEY TRANSPLANT RECIPIENTS

Medical Journal ◽

10.51922/1818-426x.2021.3.65 ◽

2021 ◽

pp. 65-70

Author(s):

I.A. Kozyro ◽

◽

А.V. Sukalo ◽

О.A. Kondratenko ◽

Keyword(s):

Kidney Disease ◽

Cardiovascular System ◽

Kidney Transplant ◽

Clinical Laboratory ◽

Pediatric Nephrology ◽

Control Group ◽

Healthy Children ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Activation Markers

Damage of the cardiovascular system (cardiovascular disease, CVD) is the main cause of reduced life expectancy in children with chronic kidney disease (CKD). In the development of damage of the heart and blood vessels, both traditional factors and caused by impaired renal function, which appear already in the early stages of kidney disease, play a role. Purpose of the study: assessment of markers of the structure, function and metabolism of the heart and study of their changes in children, kidney transplant recipients. Materials and methods. 54 children, a kidney transplant recipients (Tx), who were under observation and treatment at the National Center for Pediatric Nephrology and Renal Replacement Therapy, Minsk 2nd Children's City Clinical Hospital, aged 3 to 17 years, were included in the study. The analysis of the data of the Tx group and conditionally divided subgroups: 1) with glomerular disease leading to the end stage of CKD (ESRD), n = 26; 2) with non-glomerular pathology, n = 27, in one patient the cause of ESRD was not specified. The control group consisted of healthy children from cardiology department without kidney pathology (n = 86). Results. Anamnestic, clinical, laboratory, immunological (serum concentration of T- and B-lymphocyte activation markers (RANTES and BAFF), proinflammatory (caspase 1, IL1fi and TNFa), vascular (VEGF) and tissue (TGF1p) growth factors), metabolic status (adyponectin, leptin, obestatin, vitamin D 25(OH)D), cardiospecific molecules (highly sensitive C-reactive protein (hsCRP), proBNP, transferrin, TSAT index), instrumental changes. Conclusion. Changes in the cardiovascular system in Tx are ambiguous. On the one hand, there is a significant improvement in the geometry of the myocardium and arterial hypertension, on the other hand, the atherogenic direction of metabolic changes and biochemical markers of CVD remains.

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