Lessons learned when innovations go awry: a baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study.
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2011-11
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Individuals diagnosed with impaired glucose tolerance (i.e., prediabetes) are at increased risk for developing diabetes. We proposed a clinical trial with a novel adaptive randomization designed to examine the impact of a home-based physical activity (PA) counseling intervention on metabolic risk in prediabetic elders. This manuscript details the lessons learned relative to recruitment, study design, and implementation of a 12-month randomized controlled PA counseling trial. A detailed discussion on how we responded to unforeseen challenges is provided. A total of 302 older patients with prediabetes were randomly assigned to either PA counseling or usual care. A novel adaptive design that reallocated counseling intensity based on self-report of adherence to PA was initiated but revised when rates of non-response were lower than projected. This study presents baseline participant characteristics and discusses unwelcome adaptations to a highly innovative study design to increase PA and enhance glucose metabolism when the best-laid plans went awry.
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Hall, KS, CF Pieper, DE Edelman, WS Yancy Jr, JB Green, H Lum, MJ Peterson, R Sloane, et al. (2011). Lessons learned when innovations go awry: a baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study. Translational behavioral medicine, 1(4). pp. 573–587. 10.1007/s13142-011-0075-6 Retrieved from https://hdl.handle.net/10161/30101.
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Scholars@Duke
Katherine Shepherd Hall
My research is focused on developing evidence-based physical activity interventions for older adults with an eye to preserving functional independence and quality of life. I am particularly interested in developing exercise programs to promote physical and psychological well-being among older veterans with posttraumatic stress disorder (PTSD).
David Edward Edelman
My general interests are in the improve quality of care for chronic illness, using diabetes as a model. While I have performed research on screening for, diagnosis of, and clinical severity of unrecognized diabetes in patient care settings, my current line of work is in using health systems interventions to prevent cardiovascular disease, and to improve outcomes from comorbid diabetes and hypertension.
Jennifer Brigitte Green
Diabetes Mellitus: Prevention strategies, predictors, treatment effects; kidney and other complications including cardiovascular outcomes. Utilization of EHR data to construct tools to improve the care of diabetes and comorbid conditions.
Matthew John Peterson
Dr. Peterson's broad research interests are in aging and functional decline. He has been an investigator on VA, NIH, and foundation funded clinical trials and clinical demonstration projects that examined the effect of physical activity on the mobility and function in older adults from both institutionalized and community dwelling populations. Currently Dr. Peterson is a tenured Associate Professor in the University of North Carolina Wilmington School of Nursing, where he teaches epidemiology, statistics, and advanced scientific writing. He also provides statistical support for UNCW nursing faculty on multiple federal and foundation funded projects.
Kim Marie Huffman
Determining the role of physical activity in modulating health outcomes (cardiovascular disease risk) in persons with rheumatologic diseases (rheumatoid arthritis, gout, osteoarthritis)
Integrating clinical rheumatology, basic immunology, metabolism, and exercise science in order to reduce morbidity in individuals with arthritis
Evaluating relationships between circulating and intra-muscular metabolic intermediates and insulin resistance in sedentary as well as individuals engaging in regular exercise
Addressing the role of physical activity in modulating inflammation, metabolism, and functional health in aging populations
Gregory Alan Taylor
My lab uses mouse genetic modeling and molecular and cellular techniques to study basic biochemical pathways of relevance to aging biology.
I. Aging is often accompanied by increases in inflammation. A major interest of the lab is how perturbations in the regulation of autophagy and mitochondrial dynamics in cells are linked to inflammation. One project in the lab focuses on a family of interferon-gamma and LPS regulated proteins, the Immunity Related GTPases (IRGs). The lab has shown that mice and cells lacking one of these proteins, Irgm1, have excessive inflammatory responses that are accompanied by decreases in autophagy and mitophagy, and altered cellular metabolism. IRG genes in human (IRGM) have been linked to several inflammatory diseases including Crohn’s disease and sepsis. Current work in the lab focuses on their role in those diseases using bacterial and relevant mouse models.
II. Altered expression of the cytokine Transforming Growth Factor beta (TGF-b) has been linked with a number of aging processes, including stem cell and neural function. TGF-b is consequently a therapeutic target for a number of age-related diseases. The lab is studying a novel regulator of TGF-b expression called P311, which drives TGF-b translation. Mice have been created that lack P311 and are being used to address the role of P311 in a number of physiological processes.
Miriam C. Morey
The general focus of Dr. Morey's work is exercise and aging. All of her research examines how physical activity, exercise training, or physical fitness influence the physical functioning and/or pyschosocial quality of life of older adults. She directs a supervised hospital-based program for older adults, which is used to examine longitudinally the effects of exercise training on the musculoskeletal, articular, and cardiorespiratory systems. Furthermore, she has a number of studies that examine how system-wide impairments serve as preclinical indicators of disability and overall decline in the quality of life of older adults. Ongoing studies examine the role of exercise training in attenuation or reversal of functional decline and examination of the effectivenes of different methods of physical activity counseling for home-based exercise.
Dr. Morey's research evolves directly from three sources: (1) primary analyses of clinical trials regarding the impact of exercise on a specific outcome, (2) longitudinal analyses of participants in ongoing clinical exercise programs, and (3) secondary analyses of clinical trials which involve exercise or physical activity.
Although physical activity and exercise are the interventions of interest in all of these studies, the outcomes of interest vary considerably. Within the broad domain of aging, Dr. Morey has examined the impact of exercise on physical performance, well-being, sleep quality, disability, and functional limitations. More recently, Dr. Morey has several studies focusing on the effect of tailored telephone physical activity counseling to improve function in elders. Specific studies are targeted to newly diagnosed cancer survivors, long-term cancer survivors, and frail elders in geriatric and primary care settings.
Dr. Morey's expertise is in the area of exercise physiology and aging. She has specific knowledge in age-related changes in cardiorespiratory functioning, the effects of habitual exercise (longitudinal) on performance, and exercise programming for older adults.
Key Words: Exercise, maximal oxygen uptake, cardiorespiratory fitness, aging, disability,
functional limitations, longitudinal
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