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Policies & Procedures

• Exercise and Disability in COPD Patients
  Awarded $460,570 for the period 9/1/05 to 8/31/06
  Source: NIH

• 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

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.

• APFO: 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.

• with Jack Rejeski
  Co-Core Leaders for Clinical Research in Claude Pepper Older Americans Independence Center
  Awarded $15,149 for the period 7/1/06 to 6/30/07
  Source: NIH

Stephen P. Messier

• Fatty Acids and Inflammation in the Elderly (FAME)
  Awarded $20,000 for the period 9/1/07-8/30/08
  Source: NIH/WFU Health Services

Osteoarthritis (OA) is the most common rheumatic disease, primarily affecting the knee. Obesity is a major risk factor. While there are no cures, the use of omega-3 fatty acids consistently shows modest clinical improvements, permitting a reduction in the nonsteroidal anti-inflammatory drugs administered. This preliminary study will test whether adding the polyunsaturated fatty acids docosahexaenoic acid (DHA) plus eicosapentaenoic acid (EPA) and gamma-linolenic acid (GLA) will significantly decrease the level of inflammatory cytokines in the blood compared to a placebo. Results will be used to establish the feasibility and usefulness of a randomized clinical trial on the effects these fatty acids on inflammation and disease progression in older, obese adults with knee OA.

• with Co-PIs Gary Miller and Shannon Mihalko
  Intensive Dietary Restriction with Exercise in Arthritis
  Awarded $577,307 for the period 7/1/07 to 6/30/08
  Source: NIH

Arthritis has reached epidemic proportions in the United States. It is the leading cause of disability, affecting about one-third of adults. Osteoarthritis (OA) is the most common form, with a prevalence conservatively estimated at 21 million, or 12.1% of the US adult population. The group’s previous study showed that a 5% weight loss in obese adults with knee OA had a modest effect on clinical outcomes; however, participants remained obese at the conclusion of the intervention, so their risk of disease progression was not altered, and the relationships between weight loss and disease progression remain undetermined. This project hypothesizes that more intensive weight loss (2 to 3 times greater than previously achieved in this population) will reduce inflammation and joint loads and alter disease progression. Weight loss is the most modifiable risk factor for knee OA; however, no study has determined the extent that benefits this population. 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.

• with Suzanne C. Danhauer, Internal Medicine, Section of Hematology and Oncology, and Heidi Klepin, Internal Medicine, Section of Hematology and Oncology
  A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients with Acute Leukemia
  Awarded $20,000; $10,000 Reynolda campus, $10,000 Health Sciences
  Source: WFU Cross-Campus Collaborative Research Support Fund

  Physical activity shows promise as an innovative intervention for older adults with acute leukemia who are in the midst of a long hospital stay to decrease functional impairment throughout treatment and enhance quality of life in this understudied patient group. The project aims to demonstrate the feasibility of a randomized clinical trial. Twenty adults, aged 60 or older, hospitalized for treatment of AML, will complete self-report questionnaires and physical function testing at baseline, postintervention, and readmission to hospital several weeks postdischarge. The test will consist of basic demographic, health, physical function, and quality-of-life assessments. All participants will attend an orientation session, followed by the 4-week intervention (8 group sessions, 4 individual sessions), tailored to individual patient needs and abilities and combining gentle stretching, walking, strength exercises, and cool-down activities. Pilot data will be used to develop an external grant application to support a full-power, randomized clinical trial to examine whether a physical activity intervention helps older adults hospitalized with AML.

• 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: WFU Health Sciences

  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.

  Specific goals include:
  1. to determine the physical functioning and health-related quality of life (HRQL) of women recently treated for DCIS (2-12 weeks postsurgery);
  2. to determine if a moderate, tailored exercise intervention significantly improves physical outcomes, including cardiorespiratory endurance, muscular strength and flexibility, and HRQL;
  3. to assess compliance with the intervention; and
  4. to compare DCIS participants in the proposed study with women diagnosed with stages I-III breast cancer recruited for a larger trial to describe differences in outcome measures by severity of diagnosis as well as differential effects of the exercise intervention.

• Recovery Strategies Following Breast Cancer Treatment
  Awarded a $137,506 for the period 10/1/04 to 12/31/05, Year 4 of 4
  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.

• Does Weight Loss Following Laparoscopic Roux-en-Y Gastric Bypass Surgery Improve Inflammatory Biomarkers?
  Awarded $9,900, Fall 2006
  Source: WFU Science Research Fund

  Research has shown that obesity is associated with inflammation and impaired function. Inflammatory biomarkers are produced from adipose tissue and include interleukin-6, tumor necrosis factor alpha, and leptin. Mild weight loss in obese older adults improves function and slightly reduces inflammatory markers. However, the effect of extreme weight loss on these measures as a result of bariatric surgery is not known. This project aims to measure inflammatory biomarkers in severely obese adults at baseline and 3 weeks, 3 months, 6 months, and 12 months following laparoscopic Roux-en-Y gastric bypass surgery.

• with Gloria Muday, Biology
  Metabolic Hormone Levels and Obesity, Weight-loss Ability, and Osteoarthritis
  Awarded $10,000 for the period 5/06 to 5/07
  Source: WFU Science Research Fund

While more than 65 percent of US adults are now considered overweight or obese, neither the cause of this epidemic nor the mechanisms underlying the comorbidities associated with it are understood. Hormones secreted by fat cells, adipocytokines, may provide insight, but their alteration in obesity, osteoarthritis, and older adults and their role in weight loss is not clear. This project will examine levels of these hormones and their receptor for a connection to body weight, osteoarthritis, and weight loss. The overall goal is to understand the metabolic alterations associated with obesity in older adults.

• 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 inidividual’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 wiith 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.

• with Tongjian You, Internal Medicine, WFUHS
  Does Weight Loss Following Laparoscopic Roux-en-Y Gastric Bypass Surgery Improve Physical Function?
  Awarded $15,000 for the period 5/6/05 to 5/15/06
  Source: WFU Cross-Campus Collaborative Research Support Fund

Nearly one in six adults in the United States reports limitations in physical function, which increases to almost one in two for those over 65. Osteoarthritis (OA) is the leading cause of impaired function and disability, and obesity is a primary risk factor for OA, especially in weight-bearing joints. Previous research has shown that a mild-to-moderate weight-loss intervention in conjunction with a structured exercise program improves physical function and lessens pain in obese older adults with knee OA. Whether more intensive weight loss provides similar benefits in a younger cohort with impaired function is not known.

This pilot study will examine physical function in obese individuals with a BMI > 35.0 kg/m2 following treatment for obesity using laparoscopic Roux-en-Y gastric bypass surgery. It hypothesizes that the greater weight loss associated with this treatment will improve physical function. The team will (1) determine self-reported physical function and performance on physical tasks after weight loss from obesity surgery; (2) examine the effects of the surgery and follow-up on body composition (including visceral fat volume); nutrient intake; biomarkers of obesity and inflammation; and metabolic syndrome health parameters, such as waist girth, blood pressure, and circulating levels of lipids, glucose, and insulin. This data will inform a full proposal for submission to external funding sources.

• 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.

• Antenatal Steroids and Blood Pressure in Childhood
  Awarded $60,226 for the period 7/1/07 to 06/30/08
  Source: NIH/Wake Forest University Health Sciences

  Antenatal steroids 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 ANS alter the developing kidney and brain, possibly by depressing the rennin-angiotensin system (RAS). These alterations lead to lifelong changes in kidney structure and function and altered cardiovascular control, predisposing the adult to hypertension.

  The project studies 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. The influence of potentially modifiable factors, like fitness, on the association between ANS and blood pressure will be analyzed to explore strategies for improving the adult health of VLBW children.

W. Jack Rejeski 

• with Jeff Katula
  SHARP-P
  Awarded $109,411 for the period 9/30/07 to 5/31/08
  Source: National Institutes of Health/ WFU Health Sciences

The goal of SHARP is to design and to test the effects of an intervention to prevent various types of cognitive decline observed with aging through physical activity and mental training. SHARP-P, a pilot program, will evaluate several questions related to feasibility and examine the independent and combined effects of physical exercise and cognitive training on executive function. This project represents collaboration between the medical school and Reynolda campus investigators in the departments of Health and Exercise Science and Psychology.

• Methodological Issues in Self-Assessment among Older Adults
  Awarded $5,000 for the period 9/15/07 to 8/31/08
  Source: NIH/Wake Forest University Health Sciences

• with Gary Miller and Paul Ribisl
  Look Ahead
  Awarded $118,219 for the period 8/1/07-7/31/08
  Source: NIH/WFU Health Sciences

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, who are overweight or obese and have type-2 diabetes 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.

• 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.

• Cooperative Lifestyle Intervention Program
  Awarded $613,526 for the period 5/1/07 to 4/30/08
  Source: NIH

  The program’s long-term objectives are: (1) to evaluate the effects of physical activity and weight-loss interventions on health outcomes for older adults in rural North Carolina; and (2) to develop innovative approaches to reach this target population. 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 Edward H. Ip, Public Health Sciences, WFUHS
  Adaptive and Standardized Assessment for Functional Ability in Older Adults
  Awarded $20,000 for the period 5/06 to 5/07
  Source: WFU Cross-Campus Collaborative Research Support Fund

The project’s immediate goal is to develop adaptive and standardized assessment for an existing instrument, designed to measure older adults’ functional ability. The instrument, FAST, originally developed by Dr. Rejeski, has been used in many large-scale research studies. However, some of its items are limited by flooring and ceiling effects and its tasks lack standardization. The incorporation of adaptive and multimedia components aims to alleviate these problems and to increase its precision in measurement. The project is viewed as the first step toward the long-term goal of building a comprehensive, state-of-the-art assessment system to support clinical and basic science research at Wake Forest.

• with Anthony Marsh
  Co-Core Leaders for Clinical Research in Claude Pepper Older Americans Independence Center
  Awarded $15,149 for the period 7/1/06 to 6/30/07
  Source: NIH

• with David Goff, Public Health Sciences - Epidemiology, WFUHS
  Translating Research into the Prevention of Diabetes Mellitus (TRIP DM) Pilot Study
  Awarded $14,978 for the period 5/6/05 to 5/15/06
  Source: WFU Cross-Campus Collaborative Research Support Fund

The overall goal of this pilot study is to demonstrate the feasibility of the proposed methods of screening, recruitment, intervention, and assessment for the Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM) trial, submitted for 5 years of funding to the National Institute of Diabetes and Digestive and Kidney Diseases in February 2004. TRIP DM is a multidisciplinary study focused on translating the results of the Diabetes Prevention Program (DPP) into practice.

This project will develop prototypes of procedures, forms, and intervention materials; recruit and intervene with 8 participants; delive the initial, intensive phase (4-months) of the proposed 2-year intervention; and conduct baseline and short term (4-month) follow-up assessments of core measures, including glucose and insulin. The results will be extremely helpful to the larger study. If the application must be revised for resubmission; the team will have essential pilot data. If the application is funded, the data will inform refinement of the approach to spur immediate research progress.

• 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.

• Physical Exercise to Prevent Disability Pilot Study (LIFE)
  Awarded $142,003 for the period 10/1/04 to 9/30/05, Year 2 of 3
  Source: National Institute on Aging (NIA)

  As Americans' life expectancy increases, preventing the 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, and before such a trial can be effectively designed and implemented, preliminary data to estimate its feasibility must be gathered.

  In response to specific guidance from the National Institute on Aging (NIA), Dr. Ribisl and colleagues will conduct a single-blind, pilot RCT comparing the value of a moderately intense physical exercise program with a health education control. A total of 500 sedentary persons aged 70-85 years who are at risk of disability will be followed at 6 sites for approximately 1 year. The combined outcome of major mobility disability, defined as the incapacity to walk 400m, or death will be assessed. As this outcome has not been used in previous RCTs, the pilot study will be the first to assess its incidence. Secondary outcomes will include ADL (activities of daily living) 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 its 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.