Research
HES Research
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| Project Name | Investigator | Description | Contact Person | Website | Recruiting Participants? | Sponsor | Collaborators | Tag | Contact Person’s Page or Email |
|---|---|---|---|---|---|---|---|---|---|
| SPARK | Eliott Arroyo | The 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) | Yes | The Indiana Center for Musculoskeletal Health | Kenneth Lim, MD, PhD; Andrew Coggan, PhD; Keith Avin, PhD; Xiaochun Li, PhD | Chronic kidney disease, observational, exercise testing | https://hes.wfu.edu/people/faculty/eliott-arroyo/ |
| FIT-INDY | Eliott Arroyo | The 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) | No | Unfunded | Kenneth Lim, MD, PhD; Nikita Samanani, PharmD | Chronic kidney disease, observational, exercise testing | https://hes.wfu.edu/people/faculty/eliott-arroyo/ |
| INVEST in Bone Health | Kristen Beavers | The 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 Lawrence | https://hes.wfu.edu/invest/ | No | NIA | Barb Nicklas, PhD, Daniel Beavers PhD, Leon Lenchik MD, Ashley Weaver PhD, Jason Fanning PhD | Weight Loss, Bone, Aging, Clinical Trial | erlawren@wakehealth.edu |
| STRONG BONES | Kristen Beavers | The 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 Cogdill | https://hes.wfu.edu/strongbones/ | Yes | NIAMS | Jamy Ard, MD, Daniel Beavers, PhD, Adolfo Fernandez, MD, Philip Kramer, PhD, Ashley Weaver, PhD | Weight Loss, Bone, Pharmacotherapy, Clinical Trial | https://hes.wfu.edu/people/staff/lori-shores-cogdill |
| BEACON | Kristen Beavers | The 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 Calderone | https://beaconstudy.org/ | Yes | NIA | Daniel 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, PhD | Weight Loss, Bone, Aging, Exercise, Pharamacotherapy, Clinical Trial | https://hes.wfu.edu/people/staff/christa-todoroff-calderone |
| PALS | Peter 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) | Yes | NIH-NCI / AHA | W. 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 trial | https://hes.wfu.edu/people/staff/sam-norton |
| HALLO-P | Jason 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) | Yes | NIA | Jack Rejeski, PhDBarb Nicklas, PhDMichael Miller, PhDStephen Kritchevsky, PhD | Behavioral Sciences,Clinical Trial | https://hes.wfu.edu/people/faculty/jason-fanning |
| MORPH-II | Jason 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 Fanning | https://www.behavioralmedicinelab.org/morph2 | No | Wells Fargo | Amber Brooks, MDJack Rejeski, PhDBarb Nicklas, PhD | Behavioral Sciences,Clinical Trial | https://hes.wfu.edu/people/faculty/jason-fanning |
| IMPACTS | Megan Bennett Irby | The 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 Irby | (none) | Yes | NIH HEAL Initiative | Glenn 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 PhD | Behavioral science, clinical trial, cancer, pain, coping, technology | https://hes.wfu.edu/people/faculty/megan-bennett-irby |
| IMPACTS-Spanish | Megan Bennett Irby | The 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 Irby | (none) | Yes | NIH HEAL Initiative | Glenn 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 PhD | pilot, clinical trial, cancer, pain, behavioral science, diversity, coping, technology | https://hes.wfu.edu/people/faculty/megan-bennett-irby |
| HELP-VM | Megan Bennett Irby | Healthy 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 Irby | (none) | Not yet | Wake Forest University, Wake Forest School of Medicine, Salisbury Research Foundation | Glenn 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 PhD | pilot, clinical trial, migraine, behavioral science, diversity, coping, veterans | https://hes.wfu.edu/people/faculty/megan-bennett-irby |
| Pepper Center Development Project | Megan Bennett Irby | The 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 Irby | (none) | Not yet | NIH-NIA | Jason Fanning PhD, Barb Nicklas PhD, Stephen Kritchevsky MD | community engagement, diversity, aging | https://hes.wfu.edu/people/faculty/megan-bennett-irby |
| TASTE | Megan Bennett Irby | The 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 Irby | (none) | Not yet | NIH-NCI | Glenn Lesser MD, Andrea Dietrich PhD, Anna Snavely PhD, Farrah Mugeot PhD, Jean-Luc Mugeot PhD | clinical trial, taste and smell abnormality, cancer, detary supplementation | https://hes.wfu.edu/people/faculty/megan-bennett-irby |
| IMPACTS-CIPN | Megan Bennett Irby | The 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 Irby | (none) | Yes | Wake Forest University, Wake Forest School of Medicine, HonorHealth (Arizona) | Glenn Lesser MD, Donald Penzien PhD, Todd Levine MD, Roy Stroud MD | Behavioral science, clinical trial, cancer, pain, neuropathy, coping, technology | https://hes.wfu.edu/people/faculty/megan-bennett-irby |
| US POINTER | Jeffrey 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 Katula | https://uspointer.net/home.cfm | Yes | Alzheimer’s Association | Laura Baker, Mark Espeland, Jo Cleveland, Jeff Williamson | Behavioral Sciences,Clinical Trial,Alzheimer’s Disease | https://hes.wfu.edu/people/faculty/jeffrey-katula |
| PREDICTS | Jeffrey 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) | No | Omada, Inc. | Emily Dressler | Behavioral Sciences,Clinical Trial,Diabetes Prevention | https://hes.wfu.edu/people/faculty/jeffrey-katula |
| LIVES | Jeffrey 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) | Yes | Translational Science CenterHealth & Exercise Science | Jason Fanning, Andrew Wells, Sergi Garcia-Retortillo, Anthony Sali | Behavioral Sciences, Clinical Trial, Cognition, Aging | https://hes.wfu.edu/people/faculty/jeffrey-katula |
| TOPS (Coordinating Center) | Steve Messier | The 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 Newman | hes.wfu.edu/tops | No | NIAMS, Arthritis Foundation, Wake Forest University | Shannon 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. Hunter | Weight Loss, Osteoarthritis, Clinical Trial, Behavioral Science, Women’s Health | https://hes.wfu.edu/people/staff/jovita-newman |
| TOPS (Site) | Shannon L. Mihalko | The 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 Newman | https://hes.wfu.edu/tops | Not Yet | NIAMS, Arthritis Foundation, Wake Forest University | Stephen 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. Hunter | Weight Loss, Osteoarthritis, Clinical Trial, Behavioral Science, Women’s Health | https://hes.wfu.edu/people/staff/jovita-newman |
| Breast Cancer Clinic | Shannon L. Mihalko | The 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) | No | Unfunded | Ed Levine, MD, Marissa Howard-McNatt, MD, Lindsey Hanson, PhD, Greg Russell, MS | Breast Cancer, Physical Activity, Strength, Range of Motion, Stiffness, Observational | https://hes.wfu.edu/people/faculty/shannon-l-mihalko |
| UPBEAT | Shannon Mihalko & Peter Brubaker | This 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) | No | NIH-NCI | W. Gregory Hundley, MD; Ralph D’Agostino, Jr., PhD; Peter Brubaker, PhD; Shannon Mihalko, PhD; Gizelle Melendez, MD; Alexander Lucas, PhD; Amy Ladd, PhD | Breast Cancer, Fatigue, Cardio-Oncology, Observational | https://hes.wfu.edu/people/faculty/shannon-l-mihalko |
| ENGAGED | Gary D. Miller | The 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 disparities | Gary D. Miller | (none) | No | NIH-NIA | Debra Diz PhD, Tina Brinkley PhD, Jill Keith PhD, TanYTa Gwathmey-Williams PhD | https://hes.wfu.edu/people/faculty/gary-d-miller | |
| ACE Ancillary | Gary D. Miller | The 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) | Yes | NIH and Translational Science Center | Ashley Weaver PhD | https://hes.wfu.edu/people/faculty/gary-d-miller | |
| IGROOVE-Power | Paige E. Rice | The 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 Office | Jason Fanning, PhD, Christina Hugenschmidt, PhD, Stephen Messier, PhD | Ancillary, Muscle Power, Dance | https://hes.wfu.edu/people/faculty/paige-e-rice |