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HEALTH AND EXERCISE SCIENCE
Michael J. Berry
- Reconditioning Exercise and Chronic Obstructive Pulmonary Disease III-P
Awarded $4,208.53 for the period 1/2/08 to 3/31/08
Source: National Institutes of Health/Wake Forest University Health Sciences
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 trigylceride 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
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.
Devon Dobrosielski
Evaluating Variations in NO Pathway Genes in Relation to Ischemic Stroke
Awarded $594.39 for the period 2/24/08-7/31/08
Source: NIH/WFU Health Services
This project aims to evaluate gene variants that may be involved in a three-fold elevated risk for ischemic stroke and subclinical endothelial dysfunction among young African-American women. Nitric Oxide (NO) is a well-characterized vasodilator essential to maintaining vascular tone in the systemic and cerebral circulation. Its availability largely depends on three enzymes that catalyze L-arginine to citrulline to produce NO. Preliminary results strongly implicate the NO pathway in the development of cerebro- and cardiovascular disease. This project will test the hypothesis that polymorphisms in genes affecting the generation and regulation of endothelial NO contribute to variability in endothelial function, which may lead to increased risk of vascular diseases, such as ischemic stroke, in genetically susceptible individuals.
Jeff Katula
- Translating Research in Practice (TRIP)
Awarded $61,978 for the period 8/1/07-7/31/08
Source: NIH/WFU Health Sciences
While the Diabetes Prevention Program and other trials have shown that lifestyle interventions can prevent type-2 diabetes mellitus (DM), whether they can be implemented throughout 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, clinically meaningful 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 (LHCs) lead the intensive intervention. The control consists of an individual educational intervention that incorporates community resources to assist residents in making healthier lifestyle choices. If the intensive intervention proves cost-effective, it could be disseminated to the thousands of US communities with diabetes education programs and translate to areas other than type-2 DM, such as obesity, hypertension, cardiovascular health, and cancer prevention, that benefit from activity and diet.
Anthony P. Marsh
- 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.
Shannon L. Bozoian Mihalko
-
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.
Gary D. Miller
- 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.
Patricia A. Nixon
-
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.
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