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1.
Front Health Serv ; 4: 1210166, 2024.
Article in English | MEDLINE | ID: mdl-38590731

ABSTRACT

Introduction: To support rigorous evaluation across a national portfolio of grants, the United States Department of Veterans Affairs (VA) Office of Rural Health (ORH) adopted an analytic framework to guide their grantees' evaluation of initiatives that reach rural veterans and to standardize the reporting of outcomes and impacts. Advance Care Planning via Group Visits (ACP-GV), one of ORH's Enterprise-Wide Initiatives, also followed the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. ACP-GV is a national patient-centered intervention delivered in a large, veterans integrated healthcare system. This manuscript describes how RE-AIM was used to evaluate this national program and lessons learned from ORH's annual reporting feedback to ACP-GV on their use of the framework to describe evaluation impacts. Methods: We used patient, provider, and site-level administrative health care data from the VA Corporate Data Warehouse and national program management databases for federal fiscal years (FY) spanning October 1, 2018-September 30, 2023. Measures included cumulative and past FY metrics developed to assess program impacts. Results: RE-AIM constructs included the following cumulative and annual program evaluation results. ACP-GV reached 54,167 unique veterans, including 19,032 unique rural veterans between FY 2018 to FY 2023. During FY 2023, implementation adherence to the ACP-GV model was noted in 91.7% of program completers, with 55% of these completers reporting a knowledge increase and 14% reporting a substantial knowledge increase (effectiveness). As of FY 2023, 66 ACP-GV sites were active, and 1,556 VA staff were trained in the intervention (adoption). Of the 66 active sites in FY 2023, 27 were sites previously funded by ORH and continued to offer ACP-GV after the conclusion of three years of seed funding (maintenance). Discussion: Lessons learned developing RE-AIM metrics collaboratively with program developers, implementers, and evaluators allowed for a balance of clinical and scientific input in decision-making, while the ORH annual reporting feedback provided specificity and emphasis for including both cumulative, annual, and rural specific metrics. ACP-GV's use of RE-AIM metrics is a key step towards improving rural veteran health outcomes and describing real world program impacts.

2.
Eval Program Plann ; 103: 102398, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38183893

ABSTRACT

BACKGROUND: Availability of evidence-based practices (EBPs) is critical for improving health care outcomes, but diffusion can be challenging. Implementation activities increase the adoption of EBPs and support sustainability. However, when implementation activities are a part of quality improvement processes, evaluation of the time and cost associated with these activities is challenged by the need for a correct classification of these activities to a known taxonomy of implementation strategies by implementation actors. DESIGN: Observational study of a four-stage, stakeholder-engaged process for identifying implementation activities and estimating the associated costs. RESULTS: A national initiative in the Veterans Health Administration (VHA) to improve Advance Care Planning (ACP) via Group Visits (ACP-GV) for rural veterans identified 49 potential implementation activities. Evaluators translated and reduced these to 14 strategies used across three groups with the aid of implementation actors. Data were collected to determine the total implementation effort and applied cost estimates to estimate the budget impact of implementation for VHA. LIMITATIONS: Recall bias may influence the identification of potential implementation activities. CONCLUSIONS: This process improved understanding of the implementation effort and allowed estimation of ACP-GV 's budget impact. IMPLICATIONS: A four-stage, stakeholder-engaged methodology can be applied to other initiatives when a pragmatic evaluation of implementation efforts is needed.


Subject(s)
Evidence-Based Practice , Veterans , Humans , Retrospective Studies , Program Evaluation , Evidence-Based Practice/methods , Quality Improvement
3.
Patient Educ Couns ; 120: 108116, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38150951

ABSTRACT

OBJECTIVE: Advance Care Planning (ACP) via Group Visits (ACP-GV) is an innovative patient-centered intervention used in the United States Department of Veterans Affairs (VA) healthcare system. The goal of ACP-GV is to spread ACP to veterans and caregivers in medically underserved rural areas. Veterans, caregivers and those they trust participate in a group led by clinicians in Veterans Health Administration healthcare and/or community-based settings. To learn how to facilitate ACP-GV, clinicians attend ACP-GV training. The training teaches the ACP-GV group model and the theoretical components of Motivational Interviewing (MI) (Rollnick & Miller, 1995), which are used to empower participants to have conversations about their healthcare values and preferences. Therefore, the aim is to describe the specific MI techniques utilized by group facilitators in the innovative ACP-GV intervention. DISCUSSION: We provide exemplars for how group facilitators apply the MI techniques to the group discussion with participants. Lastly, we provide a scripted case example of a coded MI-concordant session of ACP-GV delivered with veterans in a healthcare setting that can be used in future training and education for clinicians interested in facilitating ACP using a group modality. CONCLUSION: MI is a key aspect of delivering ACP-GV, a high-quality, patient-centered intervention for veterans, caregivers and those they trust.


Subject(s)
Advance Care Planning , Motivational Interviewing , Veterans , United States , Humans , Motivational Interviewing/methods , Educational Status , United States Department of Veterans Affairs
5.
Mil Med ; 188(3-4): 786-791, 2023 03 20.
Article in English | MEDLINE | ID: mdl-35801841

ABSTRACT

INTRODUCTION: The completion rate of Advance Directive (ADs) in the Veterans Health Administration (VHA) is unknown. There is substantial literature on the need for effective Advance Care Planning (ACP) that leads to an AD to ensure that health care preferences for patients are known. Advance Directive are essential to consider since ACP, which explains and plans Advance Directive, does not reach all individuals. Health inequities, such as those experienced in rural areas, continue to exist. While ACP may disproportionately affect rural-residing veterans and their providers, a VHA program was specifically designed to increase ACP engagement with rural veterans and to address several systemic barriers to ACP. MATERIALS AND METHODS: This descriptive analysis seeks to identify patient, provider, and geographic characteristics associated with higher rates of ACP participation in VHA. An observational examination of the profile of veterans and the types of ACP (e.g., individual or in groups) using administrative data for all beneficiaries receiving VHA health care services in federal fiscal year (FY) 2020 was conducted as part of a national program evaluation. The measures include patient-level data on demographics (e.g., race, ethnicity, gender), unique patient identifiers (e.g., name, social security number), geographic characteristics of patient's location (e.g., rurality defined as Rural-Urban Commuting Areas [RUCA]), VHA priority group; provider-level data (e.g., type of document definition, clinic stop codes, visit date used to verify Advance Care Planning via Group Visits [ACP-GV] attendance; data not shown), and electronic health record note titles that indicated the presence of ACP in VHA (e.g., "Advance Directive [AD] Discussion" note title, "ACP-GV CHAR 4 code"). Pearson's chi-square statistics were used for between-group comparisons based on a two-sided test with a significance level of 0.05. RESULTS: The overall rate of AD discussions among unique VHA users in FY2020 was 5.2% (95% CI: 5.2%-5.2%) and for Advance Care Planning via Group Visits, which targets rural veterans using groups, it was 1.8% (95% CI: 1.8%-1.9%). Advance Directive discussions in VHA are more successful at reaching middle age (M = 64; SD = 16), African Americans, males, veterans living in urban areas, and veterans with a VA disability (Priority Group 1-4). Advance Care Planning delivered in groups is reaching slightly younger veterans under the age of 75 years (M = 62; SD = 15), African Americans, females, disabled veterans (e.g., Priority Group 1-4), and more veterans residing in rural communities compared to the national population of VHA users. CONCLUSION: Advance Directive discussion rates are low across VHA, yet intentional efforts with ACP via group visits are reaching veterans who are considered underserved owing to residing in rural areas. Advance Care Planning needs to be a well-informed clinical priority for VHA to engage with the entire veteran population and to support the completion of ADs.


Subject(s)
Advance Care Planning , Veterans , Male , Middle Aged , Female , Humans , Aged , Veterans Health , Advance Directives , Surveys and Questionnaires
6.
Epidemiol Infect ; 150: e154, 2022 08 04.
Article in English | MEDLINE | ID: mdl-35923078

ABSTRACT

In March 2018, the US Food and Drug Administration (FDA), US Centers for Disease Control and Prevention, California Department of Public Health, Los Angeles County Department of Public Health and Pennsylvania Department of Health initiated an investigation of an outbreak of Burkholderia cepacia complex (Bcc) infections. Sixty infections were identified in California, New Jersey, Pennsylvania, Maine, Nevada and Ohio. The infections were linked to a no-rinse cleansing foam product (NRCFP), produced by Manufacturer A, used for skin care of patients in healthcare settings. FDA inspected Manufacturer A's production facility (manufacturing site of over-the-counter drugs and cosmetics), reviewed production records and collected product and environmental samples for analysis. FDA's inspection found poor manufacturing practices. Analysis by pulsed-field gel electrophoresis confirmed a match between NRCFP samples and clinical isolates. Manufacturer A conducted extensive recalls, FDA issued a warning letter citing the manufacturer's inadequate manufacturing practices, and federal, state and local partners issued public communications to advise patients, pharmacies, other healthcare providers and healthcare facilities to stop using the recalled NRCFP. This investigation highlighted the importance of following appropriate manufacturing practices to minimize microbial contamination of cosmetic products, especially if intended for use in healthcare settings.


Subject(s)
Burkholderia Infections , Burkholderia cepacia complex , Cross Infection , Aerosols , Burkholderia Infections/epidemiology , Cross Infection/epidemiology , Disease Outbreaks , Electrophoresis, Gel, Pulsed-Field , Humans , United States/epidemiology
8.
J Food Prot ; 84(6): 962-972, 2021 Jun 01.
Article in English | MEDLINE | ID: mdl-33428741

ABSTRACT

ABSTRACT: Scombrotoxin fish poisoning (SFP) is caused by the ingestion of certain fish species with elevated concentrations of histamine due to decomposition. In fall 2019, the U.S. Food and Drug Administration (FDA) was notified of 51 SFP cases including two hospitalizations from 11 states through the FDA consumer complaint system or directly from state partners. A case patient was defined as an individual who experienced a histamine-type reaction after consumption of tuna imported from Vietnam and an illness onset between 14 August and 24 November 2019. A traceback investigation was initiated at 19 points of service to identify a common tuna source. The FDA and state partners collected 34 product samples throughout the distribution chain, including from a case patient's home, points of service, distributors, and the port of entry. Samples were analyzed for histamine by sensory evaluation and/or chemical testing. Case patients reported exposure to tuna imported from Vietnam. The traceback investigation identified two Vietnamese manufacturers as the sources of the tuna. Twenty-nine samples were confirmed as decomposed by sensory evaluation and/or were positive for elevated histamine concentrations by chemical testing. Both Vietnamese companies were placed on an import alert. Seven U.S. companies and one Vietnamese company initiated voluntary recalls. The FDA released public communication naming the U.S. importers to help suppliers and distributors identify the product and effectuate the foreign company's recall. This SFP outbreak investigation highlights the complexities of the federal outbreak response, specifically related to imported food. Cultural considerations regarding imported foods should be addressed during outbreak responses when timing is critical. Collaboration with countries where confidentiality agreements are not in place can limit information sharing and the speed of public health responses.


Subject(s)
Foodborne Diseases , Tuna , Animals , Disease Outbreaks , Foodborne Diseases/epidemiology , Histamine , Humans , Marine Toxins , United States/epidemiology , Vietnam/epidemiology
9.
Medicine (Baltimore) ; 99(33): e21497, 2020 Aug 14.
Article in English | MEDLINE | ID: mdl-32871995

ABSTRACT

Selective serotonin reuptake inhibitors (SSRIs), commonly used to treat depression, are associated with loss of motivation, anergy, and lack of curiosity often referred collectively as apathy. However, this association has not been systematically assessed using a specific rating scale for measuring apathy syndrome. Our objective was to study the association between SSRI use and apathy syndrome.We conducted a retrospective chart review of 125 patients enrolled in an outpatient psychiatry clinic. The prevalence of apathy syndrome and its clinical significance (based on standardized assessment) were compared between patients treated and not treated with SSRIs. Apathy was assessed using the Apathy Evaluation Scale-clinician version with a score ranging 18-72 with higher score for worse apathy. A score of greater than 30 is considered clinically significant apathy.Among 119 patients, the mean apathy scores were significantly higher in those treated with SSRIs compared to those not treated with SSRIs (42.5 ±â€Š9.2 vs 31.3 ±â€Š6, P < .0001). The SSRI group also had a significantly higher percentage of patients with clinically significant apathy (92% vs 61%, P < .0001). Use of all SSRIs was associated with the presence of apathy. Apathy was seen in all mental health diagnostic categories with highest Apathy evaluation scale-clinician version scores in those with dementia.SSRI use may be associated with higher rates of apathy syndrome. Clinicians should specifically inquire about iatrogenic apathy syndrome when evaluating patients on an SSRI if there is suspicion of loss of motivation. Limitations of this study included retrospective nature of this study, and that majority of the sample was males. Prospective studies are needed to elucidate information regarding the prevalence, etiology, and treatment response for SSRI-associated apathy syndrome.


Subject(s)
Apathy/drug effects , Depressive Disorder/drug therapy , Selective Serotonin Reuptake Inhibitors/adverse effects , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Retrospective Studies , Syndrome
10.
Implement Sci Commun ; 1: 19, 2020.
Article in English | MEDLINE | ID: mdl-32885180

ABSTRACT

BACKGROUND: Traditionally, system leaders, service line managers, researchers, and program evaluators hire specifically dedicated implementation staff to ensure that a healthcare quality improvement effort can "go to scale." However, little is known about the impact of hiring dedicated staff and whether funded positions, amid a host of other delivered implementation strategies, are the main difference among sites with and without funding used to execute the program, on implementation effectiveness and cost outcomes. METHODS/DESIGN: In this mixed methods program evaluation, we will determine the impact of funding staff positions to implement, sustain, and spread a program, Advance Care Planning (ACP) via Group Visits (ACP-GV), nationally across the entire United States Department of Veterans Affairs (VA) healthcare system. In ACP-GV, veterans, their families, and trained clinical staff with expertise in ACP meet in a group setting to engage in discussions about ACP and the benefits to veterans and their trusted others of having an advance directive (AD) in place. To determine the impact of the ACP-GV National Program, we will use a propensity score-matched control design to compare ACP-GV and non-ACP-GV sites on the proportion of ACP discussions in VHA facilities. To account for variation in funding status, we will document and compare funded and unfunded sites on the effectiveness of implementation strategies (individual and combinations) used by sites in the National Program on ACP discussion and AD completion rates across the VHA. In order to determine the fiscal impact of the National Program and to help inform future dissemination across VHA, we will use a budget impact analysis. Finally, we will purposively select, recruit, and interview key stakeholders, who are clinicians and clinical managers in the VHA who offer ACP discussions to veterans, to identify the characteristics of high-performing (e.g., high rates or sustainers) and innovative sites (e.g., unique local program design or implementation of ACP) to inform sustainability and further spread. DISCUSSION: As an observational evaluation, this protocol will contribute to our understanding of implementation science and practice by examining the natural variation in implementation and spread of ACP-GV with or without funded staff positions.

11.
J Intellect Disabil ; 24(3): 309-325, 2020 Sep.
Article in English | MEDLINE | ID: mdl-30101664

ABSTRACT

People with intellectual disability experience disproportionately high rates of interpersonal violence (IPV) due, in part, to disability-related risks that often can be minimized through targeted intervention. In this article, we describe using an academic and community participatory research approach to develop and test the feasibility of an accessible IPV prevention program for people with intellectual disability. The Safety Class, which is an interactive, structured, eight-session, weekly face-to-face group program, was found feasible for implementation in an efficacy study. Working in partnership with the intellectual disability community through all phases of the project helps ensure the relevance, inclusion, and accessibility of The Safety Class.


Subject(s)
Community-Based Participatory Research , Crime Victims , Intellectual Disability , Patient Education as Topic , Patient Safety , Violence/prevention & control , Adult , Feasibility Studies , Health Services Accessibility , Humans , Process Assessment, Health Care , Program Development
13.
PLoS One ; 13(10): e0204529, 2018.
Article in English | MEDLINE | ID: mdl-30278056

ABSTRACT

OBJECTIVE: Area of muscle, fat, and bone is often measured in thigh CT scans when tissue composition is a key outcome. SliceOmatic software is commonly referenced for such analysis but published methods may be insufficient for new users. Thus, a quick start guide to calculating thigh composition using SliceOmatic has been developed. METHODS: CT images of the thigh were collected from older (69 ± 4 yrs, N = 24) adults before and after 12-weeks of resistance training. SliceOmatic was used to segment images into seven density regions encompassing fat, muscle, and bone from -190 to +2000 Hounsfield Units [HU]. The relative contributions to thigh area and the effects of tissue density overlap for skin and marrow with muscle and fat were determined. RESULTS: The largest contributors to the thigh were normal fat (-190 to -30 HU, 29.1 ± 7.4%) and muscle (35 to 100 HU, 48.9 ± 8.2%) while the smallest were high density (101 to 150 HU, 0.79 ± 0.50%) and very high density muscle (151 to 200 HU, 0.07 ± 0.02%). Training significantly (P<0.05) increased area for muscle in the very low (-29 to -1 HU, 5.5 ± 7.9%), low (0 to 34 HU, 9.6 ± 16.8%), normal (35 to 100 HU, 4.2 ± 7.9%), and high (100 to 150 HU, 70.9 ± 80.6%) density ranges for muscle. Normal fat, very high density muscle and bone did not change (P>0.05). Contributions to area were altered by ~1% or less and the results of training were not affected by accounting for skin and marrow. CONCLUSIONS: When using SliceOmatic to calculate thigh composition, accounting for skin and marrow may not be necessary. We recommend defining muscle as -29 to +200 HU but that smaller ranges (e.g. low density muscle, 0 to 34 HU) can easily be examined for relationships with the health condition and intervention of interest. TRIAL REGISTRATION: Clinicaltrials.gov NCT02261961.


Subject(s)
Image Interpretation, Computer-Assisted/methods , Thigh/diagnostic imaging , Tomography, X-Ray Computed/methods , User-Computer Interface , Adipose Tissue/anatomy & histology , Adipose Tissue/diagnostic imaging , Aged , Bone and Bones/anatomy & histology , Bone and Bones/diagnostic imaging , Humans , Male , Middle Aged , Muscle, Skeletal/anatomy & histology , Muscle, Skeletal/diagnostic imaging , Organ Size , Resistance Training , Thigh/anatomy & histology , Treatment Outcome , Veterans
14.
Psychol Serv ; 14(2): 214-220, 2017 05.
Article in English | MEDLINE | ID: mdl-28481607

ABSTRACT

Communicating health care preferences in advance, so that wishes can be honored if the person becomes unable to participate in decision-making, is especially important for vulnerable populations such as homeless veterans. Hospitals are required to inform patients of their rights to document their preferences, but completion rates for advance directives are low. Conceptualizing advance health care planning as a series of health behavior steps emphasizing communication is recommended for improving engagement in advance health care planning. The authors used program evaluation data from psychoeducational groups with 288 homeless veterans to learn about their previous experience with different steps of advance health care planning and their personal goals for future steps. Results revealed a significant discrepancy between what these veterans reported they have done and information available to health care providers in the medical record: Only 26% had an advance directive in the medical record, but 70% reported they had thought about the care they would want, and almost half reported they had talked with a trusted other or named someone to make decisions for them. The most frequent goal endorsed by veterans attending groups was discussing advance health care planning with family or trusted others and/or naming someone to be a decision maker. These findings indicate a need for improved communication and documentation of veteran preferences about emergency and end of life care. Results are also consistent with interventions tailored to varying readiness for different steps of advance health care planning. (PsycINFO Database Record


Subject(s)
Advance Care Planning , Advance Directives , Ill-Housed Persons , Physician-Patient Relations , Veterans , Adult , Aged , Female , Health Behavior , Humans , Male , Middle Aged , Surveys and Questionnaires
15.
J Pain Symptom Manage ; 53(1): 1-4, 2017 01.
Article in English | MEDLINE | ID: mdl-27876636

ABSTRACT

CONTEXT: The Measuring What Matters initiative of the American Academy of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association identified documentation of a surrogate decision maker as one of the top 10 quality indicators in the acute hospital and hospice settings. OBJECTIVES: To better understand the potential implementation of this Measuring What Matters quality measure #8, Documentation of Surrogate in outpatient primary care settings by describing primary care patients' self-reported identification and documentation of a surrogate decision maker. METHODS: Examination of patient responses to self-assessment questions from advance health care planning educational groups conducted in one medical center primary care clinic and seven community-based outpatient primary care clinics. We assessed the concordance between patient reports of identifying and naming a surrogate decision maker and having completed an advance directive (AD) with presence of an AD in the electronic medical record. RESULTS: Of veterans without a documented AD on file, more than half (66%) reported that they had talked with someone they trusted and nearly half (52%) reported that they had named someone to communicate their preferences. CONCLUSIONS: Our clinical project data suggest that many more veterans may have initiated communications with surrogate decision makers than is evident in the electronic medical record. System changes are needed to close the gap between veterans' plans for a surrogate decision maker and the documentation available to acute care health care providers.


Subject(s)
Advance Care Planning , Decision Making , Electronic Health Records , Veterans , Advance Directives , Aged , Female , Humans , Male , Middle Aged , Quality Indicators, Health Care , Self Report
16.
J Am Geriatr Soc ; 64(11): 2343-2348, 2016 11.
Article in English | MEDLINE | ID: mdl-27696341

ABSTRACT

The Veterans Affairs Geriatric Scholars Program (GSP) is a continuing professional development program to integrate geriatrics into the clinical practices of primary care providers and select associated health professions that support primary care teams. GSP uses a blended program educational format, and the minimal requirements are to attend an intensive course in geriatrics, participate in an interactive workshop on quality improvement (QI), and initiate a local QI project to demonstrate application of new knowledge to benefit older veterans. Using a retrospective post/pre survey design, the effect of GSP on clinical practices and behaviors and variation of that effect on clinicians working in rural and nonrural settings were evaluated. Significant improvement was found in the frequency of using evidence-based brief standardized assessments, clinical decision-making, and standards of care. Significant subgroup differences were observed in peer-to-peer information sharing between rural and nonrural clinicians. Overall, 77% of the sample reported greater job satisfaction after participating in GSP. The program is a successful model for advancing postgraduate education in geriatrics and a model that might be replicated to increase access to quality health care, particularly in rural areas.


Subject(s)
Education, Medical, Continuing/standards , Geriatrics/education , Health Services for the Aged/standards , Primary Health Care/standards , Quality Improvement , Veterans , Aged , Curriculum , Humans , Models, Educational , Retrospective Studies , United States , United States Department of Veterans Affairs
19.
J Pain Symptom Manage ; 51(2): 150-4, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26596879

ABSTRACT

CONTEXT: As endorsed by the palliative care "Measuring What Matters" initiative, capturing patients' direct assessment of their care is essential for ongoing quality reporting and improvement. Fostering an environment where seriously ill patients feel heard and understood is of crucial importance to modern health care. OBJECTIVES: To describe the development and performance of a self-report field measure for seriously ill patients to report how well they feel heard and understood in the hospital environment. METHODS: As part of a larger ongoing cohort study of inpatient palliative care, we developed and administered the following point-of-care item: "Over the past two days, how much have you felt heard and understood by the doctors, nurses and hospital staff?" (completely, quite a bit, moderately, slightly, not at all). Participants completed the measure before and the day after palliative care consultation. For the postconsultation version, we changed the time frame from "past two days" to "today." RESULTS: One hundred sixty patients with advanced cancer completed the preconsultation assessment, and 87% of them completed the postconsultation version. Responses encompassed full use of the ordinal scale, did not exhibit ceiling or floor effects, and showed improvement from preassessment to postassessment. The item was quick to administer and easy for patients to complete. CONCLUSION: The "Heard & Understood" item is a promising self-report quality measure for the inpatient palliative care setting.


Subject(s)
Inpatients/psychology , Palliative Care/psychology , Patient Satisfaction , Professional-Patient Relations , Quality Assurance, Health Care/methods , Self Report , Cohort Studies , Communication , Humans , Neoplasms/psychology , Neoplasms/therapy , Palliative Care/methods , United States
20.
Trials ; 16: 121, 2015 Mar 27.
Article in English | MEDLINE | ID: mdl-25872570

ABSTRACT

BACKGROUND: Immune function may influence the ability of older adults to maintain or improve muscle mass, strength, and function during aging. Thus, nutritional supplementation that supports the immune system could complement resistance exercise as an intervention for age-associated muscle loss. The current study will determine the relationship between immune function and exercise training outcomes for older adults who consume a nutritional supplement or placebo during resistance training and post-training follow-up. The supplement was chosen due to evidence suggesting its ingredients [arginine (Arg), glutamine (Gln), and ß-hydroxy ß-methylbutyrate (HMB)] can improve immune function, promote muscle growth, and counteract muscle loss. METHODS/DESIGN: Veterans (age 60 to 80 yrs, N = 50) of the United States military will participate in a randomized double-blind placebo-controlled trial of consumption of a nutritional supplement or placebo during completion of three study objectives: 1) determine if 2 weeks of supplementation improve immune function measured as the response to vaccination and systemic and cellular responses to acute resistance exercise; 2) determine if supplementation during 36 sessions of resistance training boosts gains in muscle size, strength, and function; and 3) determine if continued supplementation for 26 weeks post-training promotes retention of training-induced gains in muscle size, strength, and function. Analyses of the results for these objectives will determine the relationship between immune function and the training outcomes. Participants will undergo nine blood draws and five muscle (vastus lateralis) biopsies so that the effects of the supplement on immune function and the systemic and cellular responses to exercise can be measured. DISCUSSION: Exercise has known effects on immune function. However, the study will attempt to modulate immune function using a nutritional supplement and determine the effects on training outcomes. The study will also examine post-training benefit retention, an important issue for older adults, usually omitted from exercise studies. The study will potentially advance our understanding of the mechanisms of muscle gain and loss in older adults, but more importantly, a nutritional intervention will be evaluated as a complement to exercise for supporting muscle health during aging. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02261961, registration date 10 June 2014, recruitment active.


Subject(s)
Adaptation, Physiological , Clinical Protocols , Dietary Supplements , Immune System/physiology , Muscle, Skeletal/physiology , Resistance Training , Aged , Aged, 80 and over , Humans , Middle Aged
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