Feasibility of a Home-Based Exercise Program for Managing Posttransplant Metabolic Syndrome in Lung and Liver Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Posttransplant metabolic syndrome (PTMS) is a common contributor to morbidity and mortality among solid organ transplant recipients in the late posttransplant period (≥1 year). Patients diagnosed with PTMS are at a higher risk of cardiovascular disease and frequently experience decreased physical function and health-related quality of life (HRQL). Studies in the early posttransplant period (<1 year) have shown the benefits of facility-based exercise training on physical function and HRQL, but have not evaluated the effects on metabolic risk factors. It remains unclear whether home-based exercise programs are feasible and can be delivered at a sufficient exercise dose to have effects on PTMS. This protocol outlines the methodology of a randomized controlled trial of a partly supervised home-based exercise program in lung transplant (LTx) and orthotopic liver transplant (OLT) recipients. OBJECTIVE: This study aims to evaluate the feasibility (ie, recruitment rate, program adherence, attrition, safety, and participant satisfaction) of a 12-week individualized, home-based aerobic and resistance training program in LTx and OLT recipients initiated 12 to 18 months after transplantation, and to assess estimates of intervention efficacy on metabolic risk factors, exercise self-efficacy, and HRQL. METHODS: In total, 20 LTx and 20 OLT recipients with ≥2 cardiometabolic risk factors at 12 to 18 months after transplantation will be randomized to an intervention (home-based exercise training) or control group. The intervention group will receive an individualized exercise prescription comprising aerobic and resistance training, 3 to 5 times a week for 12 weeks. Participants will meet on a weekly basis (via videoconference) with a qualified exercise professional who will supervise exercise progression, provide support, and support exercise self-efficacy. Participants in both study groups will receive a counseling session on healthy eating with a dietitian at the beginning of the intervention. For the primary aim, feasibility will be assessed through recruitment rate, program adherence, satisfaction, attrition, and safety parameters. Secondary outcomes will be measured at baseline and 12 weeks, including assessments of metabolic risk factors (ie, insulin resistance, abdominal obesity, blood pressure, and cholesterol), HRQL, and exercise self-efficacy. Descriptive statistics will be used to summarize program feasibility and effect estimates (means and 95% CIs) for sample size calculations in future trials. RESULTS: Enrollment started in July 2021. It is estimated that the study period will be 18 months, with data collection to be completed by December 2022. CONCLUSIONS: A partly supervised home-based, individually tailored exercise program that promotes aerobic and resistance training and exercise self-efficacy may be an important intervention for improving the metabolic profile of LTx and OLT recipients with cardiometabolic risk factors. Thus, characterizing the feasibility and effect estimates of home-based exercise constitutes the first step in developing future clinical trials designed to reduce the high morbidity associated with PTMS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04965142; https://clinicaltrials.gov/ct2/show/NCT04965142. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35700.

Disparities in Clinical Trial Participation: Multilevel Opportunities for Improvement.

Current data demonstrate ongoing inequities in surgical oncology clinical trials and understanding these disparities is vital to creating a more just and equitable health care system. Analysis of participatory patterns in cooperative group surgical oncology trials demonstrates complex relationships between race, socioeconomic status, and participation in these trials at the patient level. Further analysis reveals that provider-level implicit bias plays a significant role in access to clinical trials by minority populations. Holistic approaches to addressing disparities in clinical trial participation include creating a more robust pipeline of minority surgeon-scientists, engaging in partnerships with community advocates, and promoting public policy.

Climate change in the human environment: Indicators and impacts from the Fourth National Climate Assessment.

The Fourth National Climate Assessment (NCA4) is the most comprehensive report to date assessing climate change science, impacts, risks, and adaptation in the United States. The 1,500 page report covers a breadth of topics, ranging from foundational physical science to climate change response options. Here we present information on indicators and impacts of climate change in the human environment featured in NCA4 Volume II, focusing on: air quality, forest disturbance and wildfire, energy systems, and water resources. Observations, trends, and impacts of these aspects of our changing climate will be discussed, along with implications for the future. Implications: People of the United States are already being affected by our changing climate. Information on observed changes and impacts that affect human welfare and society, along with projections for the future, is highly valuable for informing decision-makers, including utility managers, emergency planners, and other stakeholders, about climate risk assessment, adaptation, and mitigation options.

Evaluation of Malnutrition Risk in Lung Transplant Candidates Using the Nutritional Risk Index.

BACKGROUND: Malnutrition in lung transplant (LTx) candidates is an important risk factor for adverse outcomes. We sought to evaluate the Nutritional Risk Index (NRI) in LTx candidates, a validated measure of malnutrition risk in chronic disease. We aimed to characterize malnutrition risk using NRI, evaluate change in body weight between nutritional risk groups, and assess association of malnutrition risk with pretransplant and posttransplant outcomes. METHODS: Retrospective, single-center cohort study of LTx candidates (2014-2015) evaluated by a dietitian before listing. Nutritional parameters, weight change pretransplant and posttransplant, and clinical outcomes were abstracted up to 1-year posttransplant. NRI was calculated as follows: (1.519 × albumin) + (41.7 × current weight/ideal weight) with high malnutrition risk defined as the lowest quartile of NRI for cystic fibrosis (CF) and non-CF patients. RESULTS: The cohort comprises 247 LTx candidates (57% male; median age 59 y; non-CF 88%). Non-CF candidates had a greater mean NRI compared with CF patients (109 ± 11 versus 95 ± 12; P < 0.0001). 86% with high malnutrition risk maintained/gained weight (≥5%) pretransplant. In 196 LTx recipients, malnutrition risk was not associated with hospital stay, discharge disposition, or 1-year mortality. The median percent weight gain for LTx recipients in the first year was 10.5% (4.0-20.1), with high malnutrition risk recipients having comparable or greater weight gain to the low-risk group (mean difference for non CF: 6.8%; P = 0.02 and CF: -3.8%; P = 0.65). CONCLUSIONS: Malnutrition risk assessed with NRI was not prognostic of posttransplant outcomes in this retrospective cohort. LTx candidates with high malnutrition risk were able to maintain their weight pretransplant and demonstrated considerable weight gain in the first-year posttransplant.

Validation of a calcium assessment tool in postmenopausal Canadian women.

UNLABELLED: Adequate calcium intake is important for optimal bone health. Assessing dietary calcium intake, however, is neither widely done nor standardized in North American clinical practices. OBJECTIVE: Our goal was to validate a calcium assessment tool (CAT), a modified version of the Calcium Calculator™, against the 3-day food record. METHODS: Data were obtained from 348 participants in the ECKO (Evaluation of the Clinical use of vitamin K supplementation in postmenopausal women with Osteopenia) trial. In this study, CAT data was collected at baseline and 3-day food records (FRs) were collected at baseline and 3 months by trained study coordinators. CAT and 3-day FR data were compared using correlations and Bland-Altman plots. Additionally, receiver operator characteristic (ROC) curves of CAT were constructed to identify subjects with low calcium intake at thresholds of 500 mg/day and 1000 mg/day on the 3-day FR curves. RESULTS: Mean calcium intake values per day were 902 mg for the 3-day FRs and 781 mg for the CAT. The Pearson correlation was 0.57 (95% CI: 0.50-0.64). Areas under the ROC curves at thresholds of 500 and 1000 mg calcium were 0.81 (95% CI: 0.73-0.89) and 0.82 (95% CI: 0.78-0.86), respectively. CONCLUSIONS: The CAT is a valid tool for the measurement of dietary calcium intake using cut-off values of 500 mg and 1000 mg in postmenopausal women, even though there is only moderate correlation between the CAT and 3-day FR. This tool may facilitate the determination of whether calcium supplements are needed in the clinical setting.