Health and Exercise Science

Kristen Beavers

TRANSLATIONAL SCIENCE CENTER

Effect of exercise modality during weight loss on bone health in older adults

Awarded: $116,075 for the period 8/15/15 to 5/31/16

Source: National Institutes of Health (NIH)

Weight loss improves many clinical consequences of obesity; yet it is not routinely recommended for older adults partly due to the potential for bone-mass loss and age-related osteoporosis and fracture. Through this K01 Mentored Research Scientist Development Award, Dr. Beavers receives training and support to conduct a clinical study clarifying which weight-loss therapies maximize health benefits and minimize loss of bone mass and quality.

Awarded $169,007 for the period 6/16/15 to 6/30/18

Source: private sponsor

Old age and obesity are prevalent risk factors for disability, morbidity, and mortality, yet recommending intentional weight loss to older adults remains controversial due, at least in part, to the accompanying loss of fat-free mass, which may exacerbate age-related functional decline. The amount of dietary protein consumed during caloric restriction may solve this problem, but the clinical benefit to functional outcomes has not been tested. This study aims to determine whether a high-protein (≥1.0 g/kg/d) weight-loss program results in improved physical function compared to weight stability in obese, older adults at risk for mobility disability.

Pepper Center Research Career Development Core Award: Effects of Exercise Modality during Weight Loss on Bone Health in Older Adults

Awarded $1,928 for the period 7/1/14 to 8/31/14

Source: NIH / Wake Forest Baptist Health (WFBH)

The main goal of this award is to provide Dr. Beavers essential training. She will begin baseline data analysis for a clinical study to clarify which weight-loss therapies provide maximal health benefits to older adults, while minimizing loss of bone mass and quality.

Intentional weight reduction and physical and cognitive function

Awarded $16,381 for the period 7/1/14 to 8/31/14

Funding: NIH

The project examines the effect of intentional weight loss on physical and cognitive function in an ancillary study to the Look AHEAD (Action for Health in Diabetes) trial. Dr. Beavers is leading two writing groups using Look AHEAD M&M data.

Michael J. Berry

Early ICU Mobility in the Critically Injured Burn Patient

Awarded $163,494 for the period 9/20/12 to 9/19/17

Source: US Department of Defense

As a co-investigator, Dr. Berry will train exercise physiologists at the various study sites on data collection procedures and design and implement quality-control procedures addressing participant safety and burden.

Standardized Rehabilitation for ICU patients with Acute Respiratory Failure

Awarded $88,100 for the period 4/1/13 to 3/31/14

Source: NIH/WFBH

Acute respiratory failure (ARF) requiring mechanical ventilation affects 1.1 million of the 4.4 million admitted to US Intensive Care Units (ICUs) every year. Patients have an average ICU and hospital stay of 8 and 15 days, respectively, at a median cost over $30,000, and experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and impaired quality of life. While research shows that rehabilitation therapy can improve functional outcomes and lower inflammation biomarkers in the frail aged and other clinical populations, whether it can do the same for ARF patients is not known. This two-arm, randomized trial of 326 ARF patients will demonstrate that standardized rehabilitation therapy, initiated in the ICU, can reduce their hospital stay, with immediate and sustained improvement in function and quality of life. Results will inform recommendations to US hospitals to prioritize and budget for their rehabilitation.

Reconditioning Exercise and Chronic Obstructive Pulmonary Disease III-P

Awarded $4,208.53 for the period 1/2/08 to 3/31/08

Source: NIH/WFBH

No abstract.

Exercise and Regional Fat Metabolism after Menopause

Awarded $5,282.71 for the period 7/1/06 to 6/30/07

Source: NIH

The study aims to determine the cellular mechanisms by which aerobic exercise intensity affects abdominal fat loss in postmenopausal women with abdominal obesity. Specifically, it will examine the effects of low-calorie diet alone or combined with low- or high-intensity aerobic exercise on (1) region-specific fat loss, by measuring changes in abdominal and gluteal adipose tissue lipoprotein lipase activity; and 2) lipoprotein lipids, glucose tolerance, and insulin levels. Identifying how different intensities of aerobic exercise and diet affect regional uptake and mobilization of triglyceride to alter body fat distribution will enable clinicians to develop the most effective treatment to improve cardiovascular health in older women with abdominal obesity.

Exercise and Disability in COPD Patients

Awarded $460,570 for the period 9/1/05 to 8/31/06

Source: NIH

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality in the United States. The primary symptoms are shortness of breath and exercise intolerance, leading to decreased physical activity and, hence, decreased physical function and health-related quality of life and increased self-reported disability. Evidence shows that exercise therapy can improve the condition and that, if the therapy is stopped, the improvements are lost. Unfortunately, compliance rates with exercise programs are dismally low. The project’s primary goal is to determine if COPD patients randomly assigned to a lifestyle activity program will exercise more at 18 months than patients randomly assigned to a traditional exercise therapy program. The lifestyle intervention program phases out center-based activity over an initial 3-month period, while teaching using both groups and individuals to self-regulate their daily level of physical activity. We expect that this lifestyle intervention program will result in higher levels of physical activity at the end of 18 months as compared to the traditional 3-month program. The project also aims to determine the impact of these two interventions on physical function, self-reported disability, health-related quality of life, and exercise capacity.

Claude D. Pepper Older Americans Independence Centers

Awarded $10,739 for the period 7/1/06 to 6/30/07

Source: NIH

The mission of the Wake Forest University School of Medicine’s Older Americans Independence Center is to assess the risk factors of physical disability in older adults; to develop and to test effective prevention therapies; and to train new investigators with leadership qualities in research on aging and disability. Its theme, “a muscular approach to disability and its prevention,” is pursued using an interdisciplinary strategy that includes molecular biology, in vitro and animal studies, clinical research, behavioral and social sciences, and epidemiology.

Peter H. Brubaker

Transition from risk factors to heart failure: Prevalence, pathogenesis, and phenomics

Awarded $9,727 for the period 3/1/16 to 6/30/16

Source: NIH/WFHS

This study is designed to determine the prevalence of early heart failure (HF); elucidate its pathogenesis; and define the critical antecedent risk-factor combinations driving the transition from Stage B to Stage C in 3,500 older adults attending the year-15 examination as part of the Multi-Ethnic Study of Atherosclerosis (MESA).

Understanding and predicting fatigue, CV decline, and events after breast cancer treatment

Awarded $37,084 for the period 9/1/15 to 8/31/16

Source: NIH/ WFBH

In this trial, Dr. Brubaker will co-direct, with Dr. Kitzman, the cardiopulmonary testing (CPX) laboratory, processing, managing, and analyzing outcome data for each participant; performing the initial validation of each CPX laboratory; and ensuring quality control of the CPX laboratories throughout the trial.

Exercise intolerance in older HFPEF patients (SECRET II)

Awarded $41,024 for the period 4/15/15 to 3/31/16

Source: NIH/WFHS

This randomized, single-blinded, 24-week intervention trial examines the effects of adding resistance training to caloric restriction (CR) and aerobic exercise training (AT) in 100 overweight/obese patients over 60 years old and diagnosed with heart failure with preserved ejection fraction (HFpEF).

Project SEARCH

Awarded $3,750 for the period 7/14/13 to 7/20/13

Source: Northwest North Carolina Area Health Education Center (NWAHEC)

Project SEARCH is a one-week program designed to increase high school students’ interest in biomedical careers. Lecture and laboratory experiences explore topics in applied anatomy and physiology.

Neural Cardiac Therapy for Heart Failure

Awarded $76,250 for the period 4/25/11 to 12/31/14

Source: Guidant Europe NV

The NECTAR-HF feasibility trial is designed to evaluate the application of right-sided vagal nerve stimulation, also called NeuroCardiac Therapy (NCT), to test the hypothesis that it will attenuate cardiac remodeling, improve cardiac function, and increase exercise capacity. Results may be used to support future NCT development and a pivotal trial.

Restoration of Chronotopic Competence in Heart Failure Patients with Normal Ejection Fraction

Awarded $76,000 for the period 3/1/08-12/31/11

Source: Boston Scientific CRM

No abstract.

with Paul Ribisl

Physical Exercise to Prevent Disability, Pilot Study (LIFE)

Awarded $55,393 for the period 9/1/06 to 10/31/07

Source: NIH

As Americans’ life expectancy increases, preventing decline in physical function and disabilities associated with age has emerged as a major clinical and public health priority. Older people who lose mobility are less likely to remain in the community; have higher rates of hospitalization, morbidity, and mortality; and experience a poorer quality of life. While studies suggest that physical exercise may prevent disability, only a Phase 3 randomized controlled trial (RCT) can provide the evidence. Before such a trial can be effectively designed and implemented, feasibility data must be gathered. This single-blind, pilot RCT compares the value of a moderately intense physical exercise program with a health education control. Five hundred sedentary persons aged 70-85 who are at risk of disability will be followed at 6 sites for approximately 1 year. This study is the first to assess the combined outcome of major mobility disability, defined as the incapacity to walk 400m, or death. Secondary outcomes include activities of daily living (ADL) disability, major fall injuries, and cardiovascular events. Effects of the intervention on physical performance measures, cognitive function, health-related quality of life, and use of health care services will be explored as well as cost-effectiveness. This pilot study will yield the necessary preliminary data to design a definitive Phase 3 RCT. By providing a conclusive answer about whether physical exercise is effective for preventing major mobility disability or death, the results of the full-scale trial will have major clinical and public health relevance.

ACTION: A Congestive Heart Failure Patient Trial Investigating Outcomes of Exercise Training

Awarded $3,171 for the period 8/1/06 to 7/31/07

Source: NIH

The ACTION trial’s primary aim is to determine the long-term safety and efficacy of adding exercise training to standard care for congestive heart failure patients. The secondary objective is to determine the incidence and significance of exercise-related complications; specifically, what characteristics increase benefits or risks from exercise. The trial will take place over 5 years, with an initial 3 months for planning, training, and implementation; 3 years of enrollment; 6 months of follow-up; and 1 year for close-out, analysis, and presentation.

Jeff Katula

The Community-Based Therapy for Fibromyalgia Project

Awarded $9,784 for the period 12/1/13 to 12/31/15

Source: Northwest Community Care Network (NWCCN)/WFHS

Dr. Katula will design, implement, and manage a structured exercise program and be responsible for training exercise interventionists, developing intervention materials, managing participants, ensuring intervention fidelity, and collecting and managing intervention-related data.

Maya Angelou Center for Health Project 1

Awarded Awarded $17,985 for the period 3/1/15 to 2/29/16

Source: NIH/WFBH

Healthy Living Partnerships to Control Diabetes (HELP Diabetes) tests an intervention designed to achieve 7% weight loss and increase physical activity to >175 minutes per week among minority and lower income diabetes patients. The 12-month, primarily group-based lifestyle intervention, modeled on Look AHEAD, is delivered by a partnership of diabetes educators and community health workers in community settings. The primary hypothesis holds that the community-based intervention will result in a 10% reduction in CVD risk compared to the enhanced usual care condition. Translating evidence-based lifestyle strategies to target underserved patients will yield a model for addressing the burden of health disparities.

HELP PD II

Awarded $17,695 for the period 8/1/15 to 7/31/16

Source: NIH/WFBH

The Healthy Living Partnership to Prevent Diabetes (HELP PD) trial randomized 300 overweight and obese people with prediabetes to usual care or a group-based lifestyle intervention facilitated by community health workers and diabetes care center staff. Recruitment, retention, intervention, and assessment have been excellent, and 6-month weight loss averaged 6.4%. This competitive renewal tests the long-term glucose-lowering effects of the HELP PD intervention by randomizing the lifestyle intervention group to continued group or self-directed maintenance and following the usual care group for comparison.

Maya Angelou Center for Health, Project 2 (WFBH PI: Calles)

Awarded $22,391 for the period 8/1/12 to 2/28/13

The current social environment promotes negative behavioral patterns related to physical activity and diet, producing epidemics of obesity, metabolic syndrome, and Type 2 diabetes mellitus (T2DM). The toll of these conditions is staggering, especially in ethnic groups that are disproportionately affected. The Diabetes Prevention Program (DPP) demonstrated T2DM prevention through lifestyle interventions that promote weight loss. This project translates its findings into practice for Latinos by identifying those at risk based on HbA1c measurement, rather than an oral glucose tolerance test and delivering a group-based, rather than an individual-based, intensive behavioral intervention using a church partners network and bilingual Latino lay health advisors. Combining proven diet and exercise strategies with the accountability and structure of Latino church communities will enhance health-related behaviors to reduce T2DM incidence. Moreover, because many chronic diseases are influenced by activity and diet, this approach should yield public health benefits in other areas and provide a model for Latino community-based health promotion programs.

Translating Research in Practice (TRIP)

Awarded $61,524 for the period 8/1/09 to 7/31/10

Source: NIH/WFBH

The Diabetes Prevention Program and other trials have shown that lifestyle interventions can prevent type-2 diabetes mellitus (DM). This 480-participant, randomized trial tests the hypothesis that administering a lifestyle intervention through a community-based diabetes prevention program will have a clinically meaningful, beneficial impact on fasting glucose (primary outcome); physical activity, dietary intake, weight, and waist circumference (secondary outcomes); and cost-effectiveness (tertiary outcome). A group-based lifestyle intervention that promotes healthy eating, increased physical activity, and modest yet achievable (5-7%) weight loss is delivered in a 6-month intensive phase followed by an 18-month maintenance phase. Lay health counselors lead the intensive intervention; an individual educational intervention incorporating community resources to guide healthier lifestyle choices is the control. If the intensive intervention proves cost-effective, it could be disseminated to the thousands of US communities with diabetes education programs and translate to other conditions that benefit from activity and diet, such as obesity, hypertension, cardiovascular health, and cancer prevention.

see also W. Jack Rejeski

Anthony P. Marsh

Physical Exercise to Prevent Disability, Pilot Study – LIFE Field Center

Awarded $106,238 + $4000 + $234,843 + $243,063 + $84,133 + $13,239.02 + $13,102 for the period 9/30/09 to 11/30/15

Source: NIH/WFBH

This Phase 3, single-masked, multicenter randomized controlled trial compares the effects of a moderate-intensity physical activity program to a health education program in sedentary older persons at risk of disability. The primary aim is to assess the interventions’ long-term effects on the ability to walk 400m. Secondary aims assess their effects on cognitive function; serious fall injuries; persistent mobility disability; major mobility disability or death; disability in daily living activities; and cost-effectiveness. Tertiary aims assess their effects on mild cognitive impairment or dementia within subgroups defined on the basis of ethnicity/race, gender, and baseline physical performance. Results will demonstrate whether physical activity is effective and practical for preventing major mobility disability and lead to new clinical guidelines.

Trial of Vitamin D supplementation and neuromuscular function in older adults

Awarded $26,077 for the period 5/1/13 to 4/30/16
Source: NIH/WFBH

Dr. Marsh will develop and implement strength assessment protocols and procedures for collecting postural sway data and collaborate extensively with other study investigators and personnel regarding biomechanics data collection, management, reduction, and analysis.

with W. Jack Rejeski

Cooperative Lifestyle Intervention Project (CLIP II)

Awarded $632,564 for the period 3/1/15 to 2/29/16

Source: NIH

In a recent position statement, the American Heart Association identified weight management as crucial to secondary prevention programs for cardiovascular disease (CVD). Obesity also affects metabolic syndrome (MetS), a common condition in CVD patients, and a known risk factor for physical disability. CLIP, funded by the National Heart, Lung, and Blood Institute, randomized 288 obese older adults with CVD or MetS to a successful aging control treatment (SA), aerobic exercise training (AT), or AT+diet-induced weight loss (WL) for 18 months. Mobility improved significantly in the AT group compared to the SA group, but the overall improvement observed with AT+WL was superior and clinically significant. This follow-up project is the first large-scale, randomized, controlled clinical trial comparing the efficacy of WL to WL+physical activity in obese, older adults with CVD or MetS, and its translational significance is increased by delivering the interventions at YMCAs. The design also permits comparison of WL+AT and WL+resistance exercise training (RT) on muscle strength.

Co-Core Leader for Pepper Center Clinical Research

Awarded $10,313 for the period 7/1/15 to 6/30/16

Source: NIH/WFBH

The Clinical Research Core of the Wake Forest University Older Americans Independence Center provides the infrastructure and resources essential to successful studies. It is well integrated with other cores in bio-imaging, molecular science, biostatistics, and data management to support externally funded projects on the pathways affecting physical function in the elderly. Resources include: 1) expertise in experimental study design and conduct; 2) highly efficient and effective participant recruitment, including women and minorities; 3) a standardized physical function assessment battery; 4) procurement, storage, and analysis of muscle and adipose tissue and blood samples; 5) maintenance of a uniform outcomes database; and 6) assistance with IRB and other regulatory filings for junior investigators.

Demo II: Loss of adipose tissue and physical function responses to exercises

Awarded $96,483 for the period 7/1/12 to 6/30/13

Source: NIH

Evidence that excess fat mass, independent of muscle mass, is a risk factor for decline in physical function with aging is conclusive. While chronic resistance exercise improves function in normal-weight older adults, obese individuals may not experience the same benefit. Since specific inflammatory factors secreted by adipose tissue have direct effects on the morphologic and metabolic properties of skeletal muscle, this randomized, clinical trial in 130 older (65-79 yrs), obese (BMI=30-34.9 kg/m2), sedentary women and men with low physical function is designed to determine whether adding caloric restriction to a standardized, progressive resistance training program improves skeletal muscle and overall physical function. It will also clarify in vitro the effects on specific biological factors, including single muscle fiber strength, fat storage in muscle fibers, and inflammation in muscle and fat tissue.

Gene therapy in canine X-linked myotubular myopathy

Awarded $3,508 for the period 4/1/11 to 3/31/12

Source: AFM

Dr. Marsh’s laboratory will perform gait analysis in XLMTM dogs using his published methods.

PFO: Powered-Ankle Foot Orthoses for Gait

Awarded $41,564 for the period 1/1/06 to 12/31/06

Sarcopenia, the progressive loss of muscle mass with advanced age, affects approximately 45% of the older US population. To counteract functional limitations, a number of studies have shown the efficacy of resistance training programs. However, they are difficult to implement as part of traditional clinical care or research protocols, because they are expensive, time-consuming, and pose problems for adherence. They also do not provide systematic control of the variable of interest: muscle power. This project uses powered-ankle foot orthoses (PAFOs) to understand how changes in ankle power influence preferred gait speed and economy. A secondary goal is to assess the influence of changes in ankle muscle power on spatio-temporal gait parameters (stride length, stride rate), gait stability, and lower extremity electromyography. The study hypothesizes that increases or decreases in ankle muscle power will lead to increases or decreases in preferred gait speed and economy.

Stephen P. Messier

Strength Training And Running Study (STARS)

Awarded $497,930 for the period 12/15/15 to 12/14/16

Source: US Department of Defense

Running reduces the incidence of some chronic diseases, decreases disability and pain, enhances perceptions of health-related quality of life, and lowers healthcare costs. Unfortunately, these benefits can be offset by the risk of injury: up to 65 percent of runners sustain an overuse injury each year, and a high proportion of military recruits are discharged due to injuries suffered during training. Female soldiers tend to incur lower extremity injuries at a higher rate than their male counterparts. This study compares the incidence of overuse, lower extremity running injuries in female adult recreational and competitive runners during and 9 months after a 9-month strength training program as compared to a control group. Its effects on strength, pain, and performance self-efficacy will also be assessed.

Strength Training and Arthritis Trial (START)

Awarded $817,475 for the period 9/1/15 to 8/31/16

Source: NIH

Muscle loss and fat gain contribute to the disability, pain, and morbidity associated with knee osteoarthritis (OA). Thigh muscle weakness is an independent and modifiable risk factor. Treatment guidelines recommend strengthening, but studies lasting just 6-to-24 weeks have used intensities below recommended levels. This 19-month, high-intensity strength-training intervention for older adults with knee OA focuses on improving thigh composition sufficiently to change knee-joint forces, decrease inflammation and pain, and slow disease progression over the long-term.

Weight loss and exercise for communities with arthritis in North Carolina (WE CAN)

Awarded $1,160,852 for the period 9/1/15 to 8/31/16

Source: NIH

Obesity is a modifiable risk factor for knee osteoarthritis (OA), and weight loss is an effective nonpharmacologic treatment to reduce pain. Under ideal, highly controlled circumstances, the WFU research team determined that 10% diet-induced weight loss combined with exercise was twice as effective at relieving pain as either intervention alone. This pragmatic community-based trial will determine if these benefits can be translated to real-world settings. Results will provide a blueprint for clinicians and public health officials in urban and rural communities to implement a much-needed weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese adults with knee OA.

with Shannon Mihalko

The Runner’s and Injury Longitudinal Study (TRAILS): Injury Recovery Supplement

Awarded $364,001 for the period 8/15/14 to 7/14/15

Source: United States Army Medical Research and Materiel Command (USAMRMC)

The supplement to this 2-year prospective observational study focuses on injury recovery. It enhances the parent project by determining whether the severity of an overuse running injury affects the duration of recovery, magnitude of chronic changes in strength and gait mechanics, and psychological well being and pain. Determining whether the effects of a significant overuse injury are evident after the symptoms subside has important public health implications, helping clinicians to determine whether return to pre-injury activity is appropriate, further treatment is required, or the injured runner exhibits chronic biomechanical and strength abnormalities that increase the risk of early onset osteoarthritis and disability.

Strength Training and Arthritis Trial (BIRT)

Awarded $137,703 for the period 9/1/13 to 8/31/14

Source: NIH

Loss of quadriceps muscle strength contributes directly to the pain, disability, and morbidity associated with knee osteoarthritis (OA) and may actually precede disease development. The parent BIRT study brings together for the first time experts in muscle biology and joint biology/ biomechanics to assess muscle adaptations that may contribute to the strength loss seen in knee OA. Biopsies from the vastus lateralis muscle of healthy control subjects and patients with knee OA will be assessed for fiber morphology, size, and type, as well as markers of immune cell infiltration. Aim 1 will test the hypothesis that knee OA is associated with neutrophil and pro-inflammatory microphage infiltration in the quadriceps muscle. Aim 2 will determine whether knee OA is associated with alterations in muscle progenitor populations that result in fat accumulation and fibrosis rather than repair, maintenance, and growth. Results will inform future studies to identify those most at risk for strength loss early in the disease process; the characteristics of those who do or do not respond to exercise; and the optimal exercise prescription to target the identified adaptations.

Pain management in osteoarthritis: Clinical benefits and cost effectiveness

Awarded $48,744 for the period 5/1/15 to 4/30/16

Source: NIH/Brigham & Women’s Hospital

The WFU team’s body of work has advanced understanding of nonpharmacologic treatment for knee osteoarthritis (OA) in three large-scale clinical trials. Data from these trials will support a computer simulation model for the delivery of nonpharmacologic pain management in OA patients.

Intensive Diet and Exercise in Arthritis (IDEA) Follow-up Study

Awarded $25,000 for the period 6/1/11 to 5/31/12

Source: NIH/WFBH

Arthritis is the leading cause of disability in the United States, affecting about one-third of adults. Osteoarthritis (OA) is the most common form, with a prevalence conservatively estimated at 12.1% of the adult population. Weight loss is the most modifiable risk factor for knee OA; this study could make intensive weight loss the standard-of-care for overweight and obese adults with knee OA, as it enhances our understanding of the OA disease process and weight-loss recommendations for older people generally. In this follow-up, investigators will see if early participants in the study have maintained their weight loss and the status of their OA.

Toward Reduction of Knee Injuries in the Military

Awarded $598,844 for the period 6/1/10 to 5/31/12

Source: Army Research Office (ARO)

This prospective observational study aims to determine the biomechanical, behavioral, and physiologic risk factors for runners who sustain an anterior knee pain overuse injury, the most common runners’ overuse injury. It will test 100 noninjured runners and monitor their training and injury status during an 18-month training period. The sample will include some who have never been injured as well as previously injured runners who have been free of discomfort attributable to the injury for 6 months. A variety of biomechanical, physiologic, and behavioral primary and secondary outcomes will be measured at baseline, 6, 12, and 18 months. The ultimate goal is to design interventions to reduce these injuries and to rehabilitate injured runners.

Intensive Dietary Restriction with Exercise in Arthritis

Awarded $588,938 for the period 7/1/10 to 6/30/11

Source: NIH

Arthritis has reached epidemic proportions in the United States; the leading cause of disability, it affects about one-third of adults. Osteoarthritis (OA) is the most common form, with a prevalence conservatively estimated at 21 million, or 12.1 percent of the US adult population. Dr. Messier’s group has shown the modest effect of 5% weight loss on clinical outcomes in obese adults with knee OA; however, participants remained obese at the end of the intervention, so their risk of disease progression was not altered, and the relationships between weight loss and disease progression remained undetermined. This project hypothesizes that more intensive weight loss—2-3 times any previously achieved in this population—will reduce inflammation and joint loads and alter disease progression. It could make intensive weight loss the standard-of-care for overweight and obese adults with knee OA, as it elucidates the OA disease process and weight-loss recommendations for older people generally.

Fatty Acids Arthritis and Inflammation in the Elderly (FAME)

Awarded $20,000 for the period 11/1/08 to 11/1/09

Source: Gene Smart Ingredients, LLC

Osteoarthritis (OA) is the most common rheumatic disease, and the knee is the most affected weight-bearing joint. Obesity is a major risk factor. This project will test the hypothesis that supplementing the polyunsaturated fatty acids eicosapentaenoic acid (EPA) and gamma-linolenic acid (GLA) will significantly decrease the level of inflammatory cytokines in the blood compared to a placebo. Even levels at the high end of normal can negatively affect cartilage and bone metabolism. Due to their small size (less than 15kDa), cytokines can readily diffuse from the systemic circulation into the joint space to act on joint tissues. Primary outcomes will be measures of the inflammatory cytokines CRP, IL-6, TNFa, and the soluble receptor sTNFR1. Secondary measures will include mobility, self-reported physical function, and pain. Results will be used to propose a randomized clinical trial of the effects of EPA and GLA on inflammation and disease progression in older, obese adults with knee OA.

Shannon L. Bozoian Mihalko

Understanding and predicting fatigue, CV decline, and events after breast cancer treatment

Awarded $37,084 for the period 9/1/15 to 8/31/16

Source: NIH/ WFBH

Dr. Mihalko will participate in the design and implementation of the protocol; training staff across study sites in techniques to enhance retention; and data analysis and interpretation.

Research on Optimal Recovery Practices: A Pilot Study in Women with Ductal Carcinoma in Situ (DCIS)

Awarded $49,998.45 for the period 4/1/04 to 3/31/05

Source: WFBH

Ductal carcinoma in situ (DCIS) is a noninvasive form of breast cancer, with a survival rate as high as 95 percent. Although its incidence is rising, little is known about how its diagnosis and treatment affect psychological and physical function or how these outcomes compare to those for women diagnosed with more advanced stages of breast cancer. The proposed study will assess the physical and psychological function of women treated for DCIS and test the impact of a behaviorally based exercise intervention on function and health-related quality of life over time. These data will be used to formulate recommendations for the rehabilitation of women with DCIS and to support a federally funded study.

Recovery Strategies Following Breast Cancer Treatment

Awarded a $137,506 for the period 10/1/04 to 12/31/05

Source: United States Army

Breast cancer is one of the most prevalent and feared diseases among women. Although treatment advances have increased survival, health care programs to improve the quality-of-life for survivors have not kept pace. Ample data on fatigue and emotional distress resulting from the diagnosis and treatment of cancer indicate that, for at least some women, significant and lasting psychosocial problems pose additional barriers to recovery. Further, most women with breast cancer now receive axillary node dissection (AND), which increases the risk of lymphedema (swelling of the arm), causing pain, psychological distress, and physical, vocational, social, and sexual impairment. This project tests whether an intervention combining a tailored exercise program, which includes lymphedema prevention, and patient education can improve the health-related quality-of-life and physical functioning for women newly diagnosed with breast cancer. Results will be used to recommend postoperative cancer care strategies.

Gary D. Miller

Policy and environmental supports for healthy eating and exercise on college campuses

Awarded $3,000 for the period 2/1/5 to 1/31/16

Source: NIH/Gramercy Research Group

Serving as the primary contact at Wake Forest University, Dr. Miller will devote effort toward the study aims; manage the IRB process; assist Drs. Price and Whitt-Glover in identifying campus dining and recreational facilities for observational assessments; and work with them to administer the NCHA-II survey on campus.

Exercise in the work place: Effect of an exercise desk in an office setting on workers’ physical and mental health

Awarded $2,500 for the period 5/1/15 to 4/30/16

Funding: Northwest AHEC

Employees with unhealthy lifestyle behaviors are less productive and capable at work and take more sick days than their counterparts with healthy lifestyles. This study will examine the effect of access to work desks that allow mild-to-moderate levels of physical activity during the day on the mental and physical health of Wake Forest Baptist Health office employees. Office administrators in two departments will be selected to participate. They will all receive an activity monitor (FitBit) and an activity wellness program. In one department, active desks will be available up to 60 minutes per day over a 6-month period. Variables of mental health (including job stress, work satisfaction, quality of life), physical health (resting blood pressure, blood lipids), and health behaviors (physical activity levels, dietary intake) will be collected at baseline, 3 months, and 6 months. Comparisons between the two departments will determine the effect of access to the active desks on physical and mental health and health behaviors.

Dietary nitrate to augment exercise benefits

Awarded $2,806 for the period 2/1/14 to 1/31/15

Source: NIH/Duke Health

Dr. Miller designed the protocol to deliver a high-nitrate supplement to participants and advised on necessary diet changes and how to improve adherence to the intervention. He is also involved in data interpretation and developing manuscripts for publication.

Increased plasma nitrite, tissue oxygenation, and functional changes in PAD

Awarded $2,820 for the period 2/1/13 to 1/31/14

Source: NIH/Duke Health

Dr. Miller advised on overall study design, particularly the diet protocol, necessary dietary changes, and how to improve adherence to the dietary intervention.

Dietary nitrate to augment exercise benefits

Awarded $2,806 for the period 2/1/13 to 1/31/14

Source: NIH/Duke Health

Dr. Miller designed the diet protocol to deliver a high-nitrate supplement to participants and advised on necessary diet changes and how to improve adherence to the intervention. He is involved in data interpretation and developing manuscripts for publication.

Parents and Children Together Preventing Diabetes (PACT PD)

Awarded $31,174 for period 9/4/12 to 8/31/13

Source: NIH/WFHS

This 4-month, 2-arm randomized clinical trial provides critical information on the early effectiveness of an innovative, family-based, behavioral intervention to prevent type-2 diabetes mellitus (T2DM). Targeting overweight/obese African American parents and their overweight/ obese 8-10-year-old children, all at risk for T2DM, it trains YMCA fitness staff to serve as family health coaches and evaluates the effects on anthropometric measures of BMI (primary outcome), waist circumference, physical activity, dietary intake, family functioning (secondary outcomes), as well as intervention fidelity, feasibility, and acceptability to participants. It will also assess the feasibility and acceptance of booster interventions to sustain motivation and the potential for retention and success in a subsequent longer term intervention.

Intentional weight reduction and physical cognitive function

Awarded $16,297 for the period 9/1/11 to 8/31/12

Source: NIH/WFBH

Diabetes is associated with increased risk of disability and accelerated decline in physical and cognitive function. This ancillary study to the on-going Look AHEAD (Action for Health in Diabetes) trial will add validated and well-established measures of physical and cognitive performance to the year-8 follow-up visit – during the trial’s weight maintenance phase – in 1,002 participants at 4 of the 16 Look AHEAD field sites. Results will provide the first direct evidence of the role of long-term intentional weight loss on the maintenance of physical and cognitive function in older obese adults with diabetes. As an ancillary study to an on-going trial, they will be achieved in a timely, cost-efficient manner.

Hydration Performance Plus (HPP)R: Acceptance, Tolerance, and Effectiveness Studies

Awarded $5,999 for the period 7/1/09 to 9/30/09

Source: NutraFood Nutrients, Inc. (Nutra3)

The market for nutrition supplements geared to improving sports performance is enormous. A product developed by Nutra3 Complex aims to improve hydration status, electrolyte balance, energy, the immune response, mental focus, and muscle fatigue in athletes and military personnel working in extreme conditions. It contains no artificial flavors, wheat, corn, gluten, nuts, or diary products, avoiding the most common sources of food allergies and intolerance. This project will investigate its acceptance, tolerance, and effectiveness in well-trained and recreational athletes in two separate studies. The first examines its acceptance in their normal dietary and training program over a 2-week period. The second will examine how individuals respond to the nutrition bar in laboratory testing with controlled exercise programs. For both studies, participants will answer questionnaires about the product, provide a history of previous diet and supplement use, and record recent exercise training. Results from these trials will provide information about the product’s tolerability, acceptability, and effectiveness.

Does Weight Loss Following Laparoscopic Roux-en-Y Gastric Bypass Improve Physical Function?

Awarded $17,401 for the period 7/1/06 to 6/30/07

Source: NIH

Nearly one in six adults in the United States report limitations in physical function, and nearly one-third are obese. Physical impairments and the comorbidities associated with obesity impose a tremendous burden to the health care economy of the nation and the individual’s quality of life. The purpose of this observational pilot study is to examine physical function in obese individuals following treatment using laparoscopic Roux-en-Y gastric bypass surgery. It hypothesizes that the intensive weight loss associated with bariatric surgery will improve physical function over a 12-month follow-up period. Secondary aims will examine the effects of the surgery and follow-up on: 1) body composition (including visceral fat volume); 2) nutrient intake; 3) biomarkers of obesity and inflammation; 4) health parameters, such as blood pressure and circulating levels of lipids, glucose, and insulin; and 5) the association of biomarkers secreted from adipose tissue with clinical measures of metabolic syndrome and physical function. Patients undergoing laparoscopic bariatric surgery with self-reported difficulty in performing mobility-associated activities will be tested presurgery and at 2 weeks and 3, 6, and 12 months postsurgery. The profound effect of intensive weight loss achieved with bariatric surgery on physical function is not well described. This study will examine the surgery’s safety and benefits in terms of metabolic measures and physical function.

Physical Activity Monitoring in the LIFE Study using the Actigraph Accelerometer

Awarded $10,685 for the period 2/14/05 to 11/15/05

Source: NIH

LIFE is a collaborative study to establish whether physical exercise effectively prevents major mobility disability or death in older people. In the pilot study, walking is the major intervention assigned to exercise group participants. During the first six months, as much as half of their increased walking will be carried out in an unsupervised setting, and at least 75% will be unsupervised for most participants during the second six months. LIFE investigators need a way to document that exercise participants significantly increased their walking compared to the healthy aging class participants. The main goal of this project is to determine if a movement sensor, the Actigraph accelerometer, can document the amount of physical activity, especially walking, among the exercise group participants after 6 months in the LIFE study. Two clinical intervention sites will collect physical activity data using the Actigraphs. If the data are acceptable, they will be sent electronically to the accelerometer data coordinating center at Wake Forest University for analysis comparing total counts per day and minutes per day of walking and similar intensity activities in participants assigned to the exercise group and the control group.

Patricia A. Nixon

Prenatal events, postnatal consequences II (competitive renewal)

Awarded $56,649 for the period 9/1/14 to 8/31/15

Source: NIH/WFBH

A significant development in prenatal care over the last 30 years is treating pregnant women at risk for premature delivery with synthetic corticosteroids to facilitate fetal lung maturation. However, data from experimental animals and epidemiological studies have raised concerns. Over the past five years, this group studied the programming effects of antenatal steroid therapy in a widely used sheep model and a cohort of adolescents. In the former, it found increases in blood pressure, reductions in nephron number, alterations in the intrarenal renin-angiotensin system (RAS), including decreased angiotensin converting enzyme 2 (ACE2), increased angiotensin type 1 receptor expression, and increased Ang II to Ang(1-7) ratio, all of which favor increased tone from Ang II stimulation of its type 1 receptor. Altered RAS was associated with ability to excrete a sodium load, decreases in baroreflex sensitivity (BRS) and heart rate variability (HRV), and increases in insulin resistance. The steroid-exposed adolescents have lower urinary ACE2, an increased ratio of urinary Ang II to Ang(1-7), and higher levels of urinary albumin. To further establish these programming effects and their consequences, the next series of studies will focus on the mechanisms of the steroid-induced alterations in renal function, BRS, insulin resistance, and the possibility that obesity exacerbates the effects of antenatal steroid exposure in both the animal model and adolescents. The work may promote identification of new, early intervention strategies to reduce the risk of hypertension and renal and metabolic abnormalities in individuals exposed to antenatal steroids.

Prenatal events, postnatal consequences

Awarded $107,792 for the period 7/1/09 to 6/30/10

Source: NIH

This supplemental project aims to compare the development and expression of blood pressure regulation systems in a group of adolescents born full-term with normal birth weight (NBW) and 200 adolescents born prematurely with very low birth weight (VLBW) and a 50% rate of exposure to antenatal steroids. Specifically, it examines alterations in the reninangiotensin system (RAS), the sympatho-adrenal system, and HPA axis. Many of these mechanisms have not been studied in children born full-term, so the impact of prematurity cannot be determined. The significance lies in the 20% increase in preterm birth since 1990 (9% since 2000) and this population’s enhanced risk of developing hypertension as well as cardiovascular and metabolic diseases in adulthood. Increasing blood pressure levels in the general adolescent population may also reflect increasing obesity and sedentary lifestyles. The data will clarify the consequences of premature birth and the underlying mechanisms of blood pressure regulation in both premature and term-born adolescents to develop early interventions to prevent hypertension and its associated cardiovascular and renal sequelae.

Prenatal Events, Postnatal Consequences

Awarded $74,844 for the period 3/15/09 to 6/30/09

Source: National Institute of Child Health and Human Development (NICHD)

Antenatal steroids and blood pressure in childhood

Awarded $48,812 for the period 7/1/09 to 6/30/10

Source: NIH

Antenatal steroids (ANS) are frequently given to mothers who are expected to deliver prematurely to improve their infants’ survival. However, ANS exposure has been associated with elevated blood pressure in these children at 14 years of age. Animal studies indicate that they alter the developing kidney and brain, possibly by depressing the renninangiotensin system (RAS), leading to lifelong changes in kidney structure and function and altered cardiovascular control, predisposing the adult to hypertension. This project studies very low birthweight (VLBW) children who were in WFUHS intensive-care nurseries and followed in the out-patient clinic. The frequency of ANS exposure is 47 percent. The project will measure resting blood pressure, blood pressure response to exercise and cold stressors, ambulatory blood pressure, RAS peptide and enzyme levels, heart-rate variability, salivary cortisol, sodium intake, body composition, and renal function to gain insight into the mechanisms of elevated blood pressure. Such modifiable factors as fitness will be analyzed as strategies for improving the adult health of VLBW children.

W. Jack Rejeski

Intervening on sedentary behavior to prevent weight regain in older adults

Awarded $46,246 for the period 10/1/15 to 9/30/16

Source: NIH/WFBH

Obesity treatment guidelines for all ages recommend an intensive lifestyle intervention involving behavioral counseling, caloric restriction, and regular exercise to achieve weight loss. However, when treatment ceases, weight regain is very common, especially among older adults. A key factor is an increase in sedentary behavior (SB): older adults spend 65-80% of their waking day sitting or prone. This study tests the efficacy of a novel, highly acceptable behavioral intervention, SitLess, which focuses on increasing awareness of SB and accelerometry-based self-monitoring throughout the day for long-term weight-loss maintenance. Results will provide the first randomized, controlled trial data on the efficacy of such self-monitoring, leading to an effective, safe, nonpharmacologic, sustainable strategy to prevent weight regain in older adults.

Low-intensity exercise intervention in peripheral artery disease

Awarded $13,205 for the period 2/1/16 to 1/31/17

Source: NIH/Northwestern University

Dr. Rejeski will serve as a co-investigator for all four study years of the LITE trial, overseeing the intervention as a whole and training and certifying the study coach. He will work with Dr. McDermott to develop behavioral components that will help participants to adhere to home-based walking exercise and assist in reviewing and interpreting the data and manuscript writing.

Patient-Centered Home Exercise Intervention to Improve Outcomes in PAD

Awarded $13,580 for the period 9/1/15 to 8/31/16

Source: Patient Centered Outcomes Research Institute/Northwestern University

Lower extremity peripheral arterial disease (PAD) is a chronic condition that adversely affects health outcomes for 8 million Americans. First, in conjunction with PAD patients and healthcare providers, we will develop, pilot test, and refine a home-based patient-centered exercise program. Second, we will conduct a randomized controlled trial to determine whether it significantly improves patient walking performance, reduces ischemia-related leg pain, and improves other selected outcomes. Results will have major implications, as current clinical practice guidelines state that there is insufficient evidence to recommend home-based walking exercise for patients with PAD.

LookAhead Extension

Awarded $15,346 for the period 8/1/14 to 1/31/16

Source: NIH/WFBH

In this long-running study, Dr. Rejeski oversees data collection on physical measures. He assists the Coordinating Center in annual training on procedures and protocols and interpretation of physical measures data; participates in assessment committee meetings and conference calls; and contributes to the resulting scientific papers.

with Anthony P. Marsh

Cooperative Lifestyle Intervention Project (CLIP II)

Awarded $577,723 for the period 3/1/16 to 2/28/17

Source: NIH

In a recent position statement, the American Heart Association identified weight management as crucial to secondary prevention programs for cardiovascular disease (CVD). Obesity also affects metabolic syndrome (MetS), a common condition in CVD patients, and a known risk factor for physical disability. The Cooperative Lifestyle Intervention Program (CLIP), funded by the National Heart, Lung, and Blood Institute, randomized 288 obese older adults with CVD or MetS to a successful aging control treatment (SA), aerobic exercise training (AT), or AT+diet-induced weight loss (WL) for 18 months. Mobility improved significantly in the AT group compared to the SA group, but the overall improvement observed with AT+WL was superior and clinically significant. This follow-up project is the first large-scale, randomized-control clinical trial comparing the efficacy of WL to WL+physical activity in obese older adults with CVD or MetS, and the translational significance is increased by its delivery at YMCAs. The design also compares the effects of WL+AT or WL+resistance exercise training (RT) on muscle strength.

Life DMAQC (Data Management, Analysis, and Quality Control Center)

Awarded $16,086 for the period 12/1/14 to 11/30/15

Source: NIH/WFHS

As life expectancy rises, older Americans’ independence has emerged as a major public health priority. Older people who lose mobility are less likely to remain in the county; have higher rates of morbidity, mortality, and hospitalization; and experience poorer quality of life. Several studies have shown that regular physical activity improves physical performance, but evidence that mobility disability can be prevented is lacking. This Phase 3, single-masked, multicenter, randomized controlled trial compares a moderate-intensity physical activity program to a health education program in sedentary older persons at risk for disability. The primary aim is to assess the long-term effects of the interventions on the ability to walk 400m. Secondary aims assess the interventions’ effects on cognitive function; serious fall injuries; persistent mobility disability; major mobility disability or death; disability in daily living activities; and cost-effectiveness. Results will have crucial implications for prevention or delay of major mobility disability and yield valuable information on the efficacy of physical activity for other health outcomes.

with Gary D. Miller and Paul Ribisl

Look Ahead

Awarded $64,720 for the period 8/1/12 to 7/31/13

Source:NIH/WFBH

This clinical trial’s primary objective is to assess the long-term (up to 11.5 years) effects of an intensive weight-loss program delivered over 4 years to overweight or obese individuals with type-2 diabetes. Approximately 5,000 men and women, 45-74 years old, are randomized to one of two groups. The intensive-lifestyle intervention is designed to achieve and to maintain weight loss through decreased caloric intake and increased physical activity. The diabetes support and education program is the control condition. The primary criterion will be time-to-incidence of major cardiovascular disease (CVD). Secondary outcomes include mortality factors related to CVD risk, cost and cost-effectiveness, diabetes control and complications, hospitalizations, intervention process, and quality of life.

Co-Core Leader for Pepper Center Clinical Research

Awarded $16,851 for the period 7/1/15 to 6/30/16

Source: NIH/WFBH

The Clinical Research Core of the Wake Forest University Older Americans Independence Center provides the infrastructure and resources essential to successful studies. It is well integrated with other cores in bio-imaging, molecular science, biostatistics, and data management to support externally funded projects on the pathways affecting physical function in the elderly. Resources include: 1) expertise in experimental study design and conduct; 2) highly efficient and effective participant recruitment, including women and minorities; 3) a standardized physical function assessment battery; 4) procurement, storage, and analysis of muscle and adipose tissue and blood samples; 5) maintenance of a uniform outcomes database; and 6) assistance with IRB and other regulatory filings for junior investigators.

Intervening on spontaneous physical activity to prevent weight regain in women

Awarded $33,130 for the period 8/1/11 to 7/31/12

Source: NIH

Weight-loss programs using caloric restriction and regular, structured exercise can lead to a reduction in physical activity performed outside the planned exercise session. This study tests whether or not women reduce their spontaneous daily physical activity more than men with weight loss and whether self-monitoring can prevent it. Results will establish whether recommendations for weight-loss maintenance in women should promote spontaneous physical activity, rather than structured exercise, during and following a period of intensive weight loss.

Longitudinal methods for complex interactions in elderly populations

Awarded: $17,228 for the period 9/1/10 to 8/31/11

Source: NIH

Cooperative Lifestyle Intervention Program

Awarded $482,419 for the period 5/1/09 to 4/30/10

Source: NIH

The Cooperative Lifestyle Intervention Program (CLIP) tests the effects of interventions to promote physical activity and weight loss on mobility disability in 300 overweight or obese men and women aged 60 to 79 years, who have cardiovascular disease or the metabolic syndrome. The interventions will be delivered in conjunction with four Cooperative Extension Centers in counties surrounding Winston-Salem to reach rural residents. Three 18-month treatments include: (1) a basic health education-based control condition, (2) a group treatment program to promote physical activity, and (3) a lifestyle intervention to encourage both physical activity and weight loss. Investigators will compare the effects of the treatments on 18-month change in performance on a 6-minute walk test, which is a valid, reliable measure of mobility disability. Secondary aims include positive changes in adiposity, physical activity, cardiovascular fitness and risk factors, and health-related quality of life. Whether changes in the primary outcome are mediated by changes in constructs from social cognitive theory will also be analyzed.

with Anthony Marsh

Bridge Funds: Co-Core Leader for Clinical Research, Pepper Center

Awarded $21,075 for the period 7/1/07 to 6/30/08

Source: NIH

Drs. Rejeski and Marsh (see above) are co-leaders of the Clinical Research Core for a 5-year Pepper Center infrastructure grant awarded by the National Institute on Aging.

with Jeff Katula

SHARP-P

Awarded $110,336 for the period 6/1/08 to 5/31/09

Source: NIH/WFBH

SHARP aims to test the effects of a physical activity and mental training intervention to prevent various types of cognitive decline observed with aging. In SHARP-P, a pilot program, investigators from the Medical School and the Reynolda campus departments of Health and Exercise Science and Psychology are collaborating to evaluate several questions related to the trial’s feasibility and to examine the independent and combined effects of physical exercise and cognitive training on executive function.

Methodological Issues in Self-Assessment among Older Adults

Awarded $5,000 for the period 9/15/07 to 8/31/08

Source: NIH/WFBH

Translating Research into Practice (TRIP)

Awarded $59,700 for the period 8/1/06 to 7/31/07

Source: NIH

While the Diabetes Prevention Program and other trials have shown that type-2 diabetes mellitus (DM) can be prevented through lifestyle interventions, whether such approaches can be implemented in the community remains unknown. This 480-participant randomized trial will test the hypothesis that a lifestyle intervention administered through a community-based diabetes prevention program will have a beneficial and clinically meaningful impact on fasting glucose (primary outcome), physical activity, dietary intake, weight, and waist circumference (secondary outcomes), and tertiary outcomes, including an economic evaluation to determine cost-effectiveness. A group-based, intensive lifestyle intervention will promote healthy eating, increased physical activity, and modest, yet achievable (5-7%) weight loss, delivered in a 6-month intensive phase followed by an 18-month maintenance phase. Lay health counselors (LHCs) will lead the intensive intervention. The control will consist of an individual educational intervention that incorporates community resources to assist residents in making healthier lifestyle choices. If the intensive intervention approach is cost-effective, this model could be disseminated to the thousands of US communities with diabetes education programs. Furthermore, many chronic diseases are influenced by activity and diet. Our lifestyle intervention, if successful, should translate into public health benefits in areas other than type-2 DM, such as obesity, hypertension, cardiovascular health, and cancer prevention.

Lifestyle Interventions and Independence in Elders (LIFE)

Awarded $7,334 for the period 9/1/06 to 8/31/07

Source: NIH

Dr. Rejeski co-chairs the Lifestyle Resource Core for this collaborative study to provide a conclusive answer about whether physical exercise effectively prevents major mobility disability or delays death in older people. The core is responsible for monitoring the fidelity and quality of the intervention; training and certifying all intervention staff; and assisting them with problem-solving and related adherence strategies throughout the project’s course.