HES Research

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Project NameInvestigatorDescriptionContact PersonWebsiteRecruiting Participants?SponsorCollaboratorsTag
SPARKEliott ArroyoThe Comparison of the Self-Paced versus Ramp Incremental Exercise Protocols on Patients with Kidney Failure (SPARK) study seeks to address the obstacles that have impeded cardiopulmonary exercise testing (CPET) in patients with chronic kidney disease by defining the optimal CPET protocol that could be uniformly implemented in this population. This cross-sectional study will compare the cardiorespiratory response to three different CPET protocols: a novel self-paced test, a ramp-incremental step-exercise test, and a standard ramp incremental test. Eliott Arroyo(none)YesThe Indiana Center for Musculoskeletal HealthKenneth Lim, MD, PhD; Andrew Coggan, PhD; Keith Avin, PhD; Xiaochun Li, PhDChronic kidney disease, observational, exercise testinghttps://hes.wfu.edu/people/faculty/eliott-arroyo/
FIT-INDYEliott ArroyoThe Cardiorespiratory Fitness in Patients with Chronic Kidney Disease in Indiana (FIT-INDY) Study seeks to investigate the relationship between kidney function and cardiorespiratory fitness in patients referred for cardiopulmonary exercise testing (CPET) in Indiana. This study will extract data from a cohort of adults at Indiana University Health and Eskenazi who received a CPET from 1/1/2005 to 01/06/2023.Eliott Arroyo(none)NoUnfundedKenneth Lim, MD, PhD; Nikita Samanani, PharmDChronic kidney disease, observational, exercise testinghttps://hes.wfu.edu/people/faculty/eliott-arroyo/
INVEST in Bone HealthKristen BeaversThe Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health study is designed to determine the effect of weight loss alone, weight loss plus weighted vest use, and weight loss plus resistance training on change in bone health among 150 older (60-85 years) adults over the course of a year. Erica Lawrencehttps://hes.wfu.edu/invest/NoNIABarb Nicklas, PhD, Daniel Beavers PhD, Leon Lenchik MD, Ashley Weaver PhD, Jason Fanning PhDWeight Loss, Bone, Aging, Clinical Trialerlawren@wakehealth.edu
STRONG BONESKristen BeaversThe Strategies to Reduce the Onset of Sleeve Gastrectomy associated Bone Loss (STRONG BONES) study is designed to definitively test whether transient bisphosphonate use can minimize bone and muscle loss associated with bariatric surgery.Lori Shores Cogdillhttps://hes.wfu.edu/strongbones/YesNIAMSJamy Ard, MD, Daniel Beavers, PhD, Adolfo Fernandez, MD, Philip Kramer, PhD, Ashley Weaver, PhDWeight Loss, Bone, Pharmacotherapy, Clinical Trialhttps://hes.wfu.edu/people/staff/lori-shores-cogdill
BEACONKristen BeaversThe Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) study is designed to determine the independent and combined effects of bone loading exercise and bisphosophonate use on weight loss associated bone loss among older adults living with overweight/obesity and low bone mass.Christa Todoroff Calderonehttps://beaconstudy.org/YesNIADaniel Beavers, PhD Jamy Ard, MD Peter Brubaker, PhD Jason Fanning, PhD Jamie Justice, PhD Barb Nicklas, PhD Ashley Weaver, PhD Julio Carballido-Gamio, PhD Wendy Kohrt, PhD Christine Swanson, MD Sarah Wherry, PhDWeight Loss, Bone, Aging, Exercise, Pharamacotherapy, Clinical Trialhttps://hes.wfu.edu/people/staff/christa-todoroff-calderone
PALSPeter H. Brubaker & Shannon L. Mihalko The Physical Activity and Lymphoma Study (PALS) is a six-month intervention designed to determine the effects of a physical activity intervention (PAI) or healthy living intervention (HLI) on peak VO2, left ventricular function, and other biopsychosocial outcomes in lymphoma patients actively undergoing treatment. Sam Norton(none)YesNIH-NCI / AHAW. Gregory Hundley, MD; Ralph D’Agostino, Jr., PhD; Peter Brubaker, PhD; Shannon Mihalko, PhD; Gizelle Melendez, MD; Alexander Lucas, PhD; Amy Ladd, PhD; Lymphoma, cancer, cardio-oncology, clinical trialhttps://hes.wfu.edu/people/staff/sam-norton
HALLO-PJason Fanning The Health, Aging and Later-Life Outcomes Planning Grant (HALLO-P) is a 12-month pilot study comparing clinically-relevant health outcomes in older persons randomized to daily caloric restriction, a time restricted feeding regimen, or a non-dietary attention using mHealth tools to promote adherence. Jason Fanning(none)YesNIAJack Rejeski, PhDBarb Nicklas, PhDMichael Miller, PhDStephen Kritchevsky, PhDBehavioral Sciences,Clinical Trialhttps://hes.wfu.edu/people/faculty/jason-fanning
MORPH-IIJason Fanning MORPH II is a follow-up randomized controlled trial based on the lessons learned from the MORPH study. Participants engage in 12 weeks of either remote group-based meetings, or they receive a set of physical activity and weight self-monitoring tools. After 12 weeks, participants enter into a 12-week no-contact maintenance program.Jason Fanninghttps://www.behavioralmedicinelab.org/morph2NoWells FargoAmber Brooks, MDJack Rejeski, PhDBarb Nicklas, PhDBehavioral Sciences,Clinical Trialhttps://hes.wfu.edu/people/faculty/jason-fanning
MORPH-III (The Mobile Intervention to Reduce Pain and Improve Health) Jason Fanning This study is designed to test the impact of a remotely-delivered weight loss and daylong movement program on physical activity levels and pain symptoms in older adults with chronic pain.Jason Fanning(none)https://hes.wfu.edu/people/faculty/jason-fanning
IMPACTSMegan Bennett IrbyThe Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS) trial is a 5-year program of research funded by the NIH HEAL Initiative designed to reduce reliance on opioid medications among patients with chronic cancer-related pain who are in treatment for, or have recently completed treatment for, their cancer. The trial will demonstrate the efficacy and effectiveness of an 8-week, cognitive-behavioral-therapy informed, internet-delivered pain coping skills training program for reducing pain intensity and pain interference.Megan Bennett Irby(none)YesNIH HEAL InitiativeGlenn Lesser MD, Donald Penzien PhD, Kathryn Weaver PhD, Emily Dressler PhD, Anna Snavely PhD, Dennis Ang MD, Mara Vitolins PhD, Steve Rapp PhD, Suzanne Danhaur PhDBehavioral science, clinical trial, cancer, pain, coping, technologyhttps://hes.wfu.edu/people/faculty/megan-bennett-irby
IMPACTS-SpanishMegan Bennett IrbyThe Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)-Spanish trial is a 2-year community-engaged research project and pilot trial funded by the NIH HEAL Initiative. In phase I of the research, community-engaged approaches were used to develop a culturally and linguistically approapriate pain coping skills training program for Hispanic/Latine individuals experiencing chronic pain related to cancer. In phase II, the resultant pain coping skills program will be pilot tested among Spanish-speaking patients with chronic cancer-related pain. The pilot trial will demonstrate the feasibility, acceptibility, and promise of the internet-delivered pain management program among Spanish speaking populations with cancer, as well as the preliminaty efficacy of the program for reducing cancer-related pain intensity and pain interference.Megan Bennett Irby(none)YesNIH HEAL InitiativeGlenn Lesser MD, Donald Penzien PhD, Kathryn Weaver PhD, Emily Dressler PhD, Anna Snavely PhD, Dennis Ang MD, Mara Vitolins PhD, Steve Rapp PhD, Suzanne Danhaur PhDPilot, Clinical Trial, Cancer, Pain, Behavioral Science, Diversity, Coping, Technologyhttps://hes.wfu.edu/people/faculty/megan-bennett-irby
HELP-VMMegan Bennett IrbyHealthy Living Partnerships for Veterans with Migraine (HELP-VM) is a pilot study being conducted in partnership with the W. G. “Bill” Hefner Salisbury VA Medical Center. This 2-year project will assess the feasiblity, acceptability, and promise of an intensive, group-based lifestyle intervention focused on increasing physical activity, promoting healthy eating, and managing headache triggers to reduce the burden of migraine among Veterans with comorbid overweight or obesity. Megan Bennett Irby(none)Not yetWake Forest University, Wake Forest School of Medicine, Salisbury Research FoundationGlenn Lesser MD, Donald Penzien PhD, Kathryn Weaver PhD, Emily Dressler PhD, Anna Snavely PhD, Dennis Ang MD, Mara Vitolins PhD, Steve Rapp PhD, Suzanne Danhaur PhDpilot, clinical trial, migraine, behavioral science, diversity, coping, veteranshttps://hes.wfu.edu/people/faculty/megan-bennett-irby
Pepper Center Development ProjectMegan Bennett IrbyThe Pepper Center Development Project is a community-engaged program of research designed to enhance participation of diverse older adults in aging research. This 4+ year project includes the formation of a community advisory board, strategic community outreach activities, focus groups with community members, and development of training materials and workshops for communities/clinicians/researchers relevant to enhancing representation of underserved groups in aging research.Megan Bennett Irby(none)Not yetNIH-NIAJason Fanning PhD, Barb Nicklas PhD, Stephen Kritchevsky MDcommunity engagement, diversity, aginghttps://hes.wfu.edu/people/faculty/megan-bennett-irby
TASTEMegan Bennett IrbyThe Taste and Smell Disturbances in Cancer Patients Receiving Therapy (TASTE) study is a randomized, placebo-controlled, pilot study investigating the preliminary efficacy of Lactoferrin (an iron-binding nutritional supplement) for the remediation of taste and smell abnormalities among patients who have received chemotherapy.Megan Bennett Irby(none)Not yetNIH-NCIGlenn Lesser MD, Andrea Dietrich PhD, Anna Snavely PhD, Farrah Mugeot PhD, Jean-Luc Mugeot PhDclinical trial, taste and smell abnormality, cancer, detary supplementationhttps://hes.wfu.edu/people/faculty/megan-bennett-irby
ICRISP: Indigenous Community-Informed Research Infrastructure to Address Substance Misuse and Pain ManagementMegan Bennett IrbyThe iCRISP project is funded by the NIH HEAL (Helping to End Addiction Long-term) and NCREW (Native Collective Research Effort to Enhance Wellness) Initiatives to address overdose, substance misuse, mental health, and pain among Native communities in North Carolina. This 2-year project features a community-engaged partnership with the Lumbee Tribe of Pembroke, North Carolina, and will focus on gathering data to describe the scope and burden of key health issues in the Lumbee community, develop a data dashboard to characterize and share data, and develop Indigenous-informed pain management and substance misuse recovery programs.Megan Bennett IrbyNot yetNIH HEAL Initiative and NIH NCREWLumbee Community, Dr. Cherry Beasley (Lumbee Tribe), & Dr. Ronny Bell (UNC-CH, Lumbee Tribe)Native health, diversity, substance use, pain management, community engagementhttps://hes.wfu.edu/people/faculty/megan-bennett-irby
IMPACTS-CIPNMegan Bennett IrbyThe Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS) Chemotherapy Induced Peripheral Neuropathy (CIPN) trial is a 2-year pilot study being conducted in partnership with neurologists from the HonorHealth system in Phoenix, Arizona. This pilot trial will assess the feasiblity, acceptability, and promise of an 8-week, cognitive-behavioral-therapy informed, internet-delivered pain coping skills training program among patients who have CIPN related to their cancer treatment. The study also will assess the preliminary efficacy of the pain coping skills training program for the management of neuropathic pain symptoms. Megan Bennett Irby(none)YesWake Forest University, Wake Forest School of Medicine, HonorHealth (Arizona)Glenn Lesser MD, Donald Penzien PhD, Todd Levine MD, Roy Stroud MDBehavioral science, clinical trial, cancer, pain, neuropathy, coping, technologyhttps://hes.wfu.edu/people/faculty/megan-bennett-irby
US POINTERJeffrey Katula The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) is a two-year clinical trial to evaluate whether lifestyle interventions that simultaneously target multiple risk factors protect cognitive function in older adults (age 60-79) at increased risk for cognitive decline. U.S. POINTER is the first such study to be conducted in a large group of Americans.Jeffrey Katulahttps://uspointer.net/home.cfmYesAlzheimer’s AssociationLaura Baker, Mark Espeland, Jo Cleveland, Jeff WilliamsonBehavioral Sciences,Clinical Trial,Alzheimer’s Diseasehttps://hes.wfu.edu/people/faculty/jeffrey-katula
PREDICTSJeffrey Katula The PREventing Diabetes through Internet Coaching for Translation and Scalability trial seeks to examine the impact of a digitial diabetes prevention program on HbA1c and body weight in patients with prediabetes.Jeffrey Katula(none)NoOmada, Inc.Emily DresslerBehavioral Sciences,Clinical Trial,Diabetes Preventionhttps://hes.wfu.edu/people/faculty/jeffrey-katula
LIVESJeffrey Katula The Lifestyle Interventions for Vitality and Empowerment of Seniors (LIVES) study is a pilot study examining the feasibility of a randomized controlled trial testing the impact of high intensity interval resistance training on cognitive and mobility in older adults. Jeffrey Katula(none)YesTranslational Science CenterHealth & Exercise ScienceJason Fanning, Andrew Wells, Sergi Garcia-Retortillo, Anthony SaliBehavioral Sciences, Clinical Trial, Cognition, Aginghttps://hes.wfu.edu/people/faculty/jeffrey-katula
Physical Activity Index Pilot StudyJeffrey Katula The purpose of this pilot study is to assess the feasibility (participation rate, adherence, and retention) of the Physical Activity Index (PAI) intervention in breast and colon cancer survivors supported by exercise coaching and self-monitoring tools. This trial partners with the Wake Forest School of Medicine.Jeffrey KatulaYesWake Forest School of MedicineKristy Wood, Shelley BluethmannRCT, Pilot, Behavioral Sciences, Physical Activity, Cancerhttps://hes.wfu.edu/people/faculty/jeffrey-katula
Healthy Brain StudyJeffrey Katula Healthy Brain Study will identify and characterize early risk factors that predict memory decline and dementia in adults with or without early signs of memory impairment.Jeffrey KatulaHealthy Brain StudyYesNIHLaura Baker, Suzanne KraftBehavioral sciences, cognition, aging, older adultshttps://hes.wfu.edu/people/faculty/jeffrey-katula
TOPS (Coordinating Center)Steve MessierThe Osteoarthritis Prevention Study (TOPS) is a phase III randomized clinical trial that is testing a critically needed primary prevention intervention on females at risk for the development of structural knee OA by implementing a program of dietary weight loss, exercise, and weight-loss maintenance designed for long-term sustainability to maximize health benefits at a reasonable cost.Jovita Newmanhes.wfu.edu/topsYesNIAMS, Arthritis Foundation, Wake Forest UniversityShannon L. Mihalko, Gary D. Miller, Leigh F. Callahan, Elena Losina, Ali Guermazi, Edward Ip, Jeffrey N. Katz, Richard F. Loeser, Brian Pietrosimone, Sandra Soto, James L. Cook, Paul DeVita, Kurt P. Spindler, Jos Runhaar, David J. HunterWeight Loss, Osteoarthritis Prevention, Clinical Trial, Behavioral Science, Women’s Healthhttps://hes.wfu.edu/people/staff/jovita-newman
TOPS (Site)Shannon L. MihalkoThe Osteoarthritis Prevention Study (TOPS) is a phase III randomized clinical trial that will test a critically needed primary prevention intervention on females at risk for the development of structural knee OA by implementing a program of dietary weight loss, exercise, and weight-loss maintenance designed for long-term sustainability to maximize health benefits at a reasonable cost.Jovita Newmanhttps://hes.wfu.edu/topsYesNIAMS, Arthritis Foundation, Wake Forest UniversityStephen P. Messier, Gary D. Miller, Leigh F. Callahan, Elena Losina, Ali Guermazi, Edward Ip, Jeffrey N. Katz, Richard F. Loeser, Brian Pietrosimone, Sandra Soto, James L. Cook, Paul DeVita, Kurt P. Spindler, Jos Runhaar, David J. HunterWeight Loss, Osteoarthritis, Clinical Trial, Behavioral Science, Women’s Healthhttps://hes.wfu.edu/people/staff/jovita-newman
Breast Cancer ClinicShannon L. MihalkoThe Strength and Range of Motion in Women Undergoing Surgery for Breast Cancer examines the anthropometrics (weight, height, waist circumference), grip strength, bicep strength, shoulder range of motion, and physical activity participation prior to surgery, at each surgical follow-up visit, and throughout survivorship after surgery for women with breast cancer.Shannon Mihalko(none)NoUnfundedEd Levine, MD, Marissa Howard-McNatt, MD, Lindsey Hanson, PhD, Greg Russell, MSBreast Cancer, Physical Activity, Strength, Range of Motion, Stiffness, Observationalhttps://hes.wfu.edu/people/faculty/shannon-l-mihalko
UPBEATShannon Mihalko & Peter BrubakerThis multi-center study will be the first to define and fully characterize the time course of Adj-C cardiotoxicity and factors (with and without radiation treatment) that influence the development of subclinical CV dysfunction, exercise intolerance, fatigue, and CV events among women of different ages and races/ethnicities.Shannon Mihalko (none)NoNIH-NCIW. Gregory Hundley, MD; Ralph D’Agostino, Jr., PhD; Peter Brubaker, PhD; Shannon Mihalko, PhD; Gizelle Melendez, MD; Alexander Lucas, PhD; Amy Ladd, PhDBreast Cancer, Fatigue, Cardio-Oncology, Observationalhttps://hes.wfu.edu/people/faculty/shannon-l-mihalko
Molecular Transducers of Physical Activity Consortium Coordinating Center (MoTrPAC)Peter H. BrubakerPeter H. BrubakerNoNIHJack Rejeski, Mike Miller, et al.Molecular Transducers, Physical Activityhttps://hes.wfu.edu/people/faculty/peter-h-brubaker/
ENGAGEDGary D. MillerThe Enhancing Undergraduate Education and Research in Aging to Eliminate Health Disparities (ENGAGED) program Medicine and its partner institutions, Wake Forest University and Winston-Salem State University. The ENGAGED program is designed to provide undergraduate students who are underrepresented in the biomedical sciences an opportunity to participate in educational and research training in aging and health disparitiesGary D. Miller(none)NoNIH-NIADebra Diz PhD, Tina Brinkley PhD, Jill Keith PhD, TanYTa Gwathmey-Williams PhDAging Researchhttps://hes.wfu.edu/people/faculty/gary-d-miller
ACE AncillaryGary D. MillerThe randomized controlled trial (RCT), ACE: Arterial Stiffness, Cognition, and Equol, is testing the effect of a 24-month intervention of 10mg/day of equol (the most bio-active soy isoflavone) on arterial stiffness, white matter disease progression, and cognitive decline in older adults (ages 65-85) without dementia (NCT05741060; R01 AG074971). This pilot proposal will facilitate baseline acquisition of DXA scans, HRpQCT scans, and blood/urine specimens for 75 participants recruited into the ACE study at Wake Forest.Gary D. Miller(none)YesNIH and Translational Science CenterAshley Weaver PhDCognition, Body Composition https://hes.wfu.edu/people/faculty/gary-d-miller
Effect of Acute and Chronic Intake of Beetroot Juice on Intraocular PressureGary D. MillerThis feasibility trial partners with the Wake Forest School of Medicine. This 4 week pilot study investigates the potential of dietary nitrates, specifically from beet root juice, as a novel treatment for glaucoma; the metabolized NO could increase vasodilation which could improve perfusion of the optic nerve and potentially improve the relationship between BP and OPP. Measurements include changes in intraocular pressure, BP, nitrate levels, and assessments of treatment adherence and feasibility for future studies on glaucoma patients. If successful, dietary nitrate could offer a viable treatment for glaucoma, with fewer side effects than current therapies and improvement in patient quality of life.Gary D. MillerYesTranslational Science Center and WFU Health and Exercise Science departmentAtalie Carina Thompson, MDGlaucoma, Beetroot Juicehttps://hes.wfu.edu/people/faculty/gary-d-miller
IGROOVE-PowerPaige E. RiceThe IGROOVE-Power ancillary study is a pilot to determine whether six months of dancing influences fall risk and lower extremity muscle power in older adults with perceived memory loss. From this data, we will also be able to ascertain whether muscular power at the knee- or ankle-joint is more predictive of fall risk. Paige E. Rice(none)Yes (through the parent trial, IGROOVE)Provost’s OfficeJason Fanning, PhD, Christina Hugenschmidt, PhD, Stephen Messier, PhDAncillary, Muscle Power, Dancehttps://hes.wfu.edu/people/faculty/paige-e-rice