The Pepper Center has a core set of resources for investigators. if you are interested in using any of the resources for your research, please contact Megan Miller.
Library of measures for Pepper investigators called Free Open Research Measurement System (FORMS). The goals of the FORMS library are to:
- promote widespread use of a brief “common data set” of core measures of mobility, balance and falls
- provide expertise on measure selection, using our FORMS system
- provide access to formats, protocols, references, psychometric data and data entry systems for an ever growing library of relevant measures
- provide training to investigators and staff on use and interpretation of measures
The FORMS library includes protocols and formats submitted from participating investigators which are reviewed by core leaders and then submitted to the DMAIC for entry into the FORMS system, an online listing of measures by domain with protocols, data entry screens, data quality checks and scoring.
Common Data Set is designed to promote pooling and comparison between studies. There are four measures in the common data set; the Short Physical Performance Battery, gait speed, a falls history, and a survey of activities and fear of falling (SAFFE).
For more information on the Clinical Assessment Library please contact Dr. Jennifer Brach or Dr. Steven Albert.
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Premier research lab for human subjects’ research on balance and mobility
The SMART Center has:
- 6000 square feet
- Offices, workstations, conference room
- Open space to conduct mobility-based research
- 180 foot oval track
- Hologic QDR-4500A X-ray Bone Densitometer with Discovery Upgrade, fan beam technology and Instant Vertebral Assessment® program
- state-of-the-art DXA based assessment of body composition and bone mineral density
- Hologic Oasis Workstation transmits bone density data to the research coordinator’s office for viewing or print-out
- Portable calcaneal ultrasound units
For more information on the SMART Center please contact Megan Miller.
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Pepper investigators can enroll frail participants in the community and in long-term care facilities.
The unit is a Supreme Commercial bus body mounted on a Ford E450 chassis.
Featured in a Discovery Channel promotional piece.
The Mobile Unit has:
- Hologic Discovery A Bone Densitometer with fan beam technology and Vertebral Fracture Assessment® program
- A wheel chair lift
- Portable stadiometer for height
- Scale for weight
- Materials for phlebotomy procedures
- Centrifuge for onsite sample processing
For more information on the Mobile Lab Unit please contact Megan Miller.
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Long-Term Care Falls Data Warehouse
- Integrates administrative data (i.e., post-falls assessments) with clinical data (i.e., lab and medications) on patients who have fallen in the nursing home setting.
- We are assessing
- the completeness of the falls administrative information entered into RiskMaster®
- if combining falls administrative data with appropriate lab and medication information provides nursing home staff with more useful information on the fall incident (i.e., determination of risk factors associated with a fall or ways to reduce future falls)
- if we can develop automated alerts to the nursing home staff to identify patients at high risk for future falls
- Pepper investigators can use the Warehouse to examin associations among falls, laboratory, medication and other clinical data from a real-time database in a large health system.
For more information on the LTC Falls Data Warehouse please contact Dr. Steven Handler.
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Medicare Current Beneficiary Survey (MCBS) Analytic Infrastructure
The MCBS data:
- continuous survey of a nationally representative panel of aged, disabled and institutionalized Medicare beneficiaries sponsored by CMS
- a wealth of data are collected related to health and functional status, including falls and injurious falls
- Data library containing files from 1996 to 2004
- Relevant analytic data sets/variables and documentation
- Expertise and specialized statistical software for analyzing survey data with complex sampling designs (SUDAAN® version 10; Research Triangle Institute, Research Triangle Park, North Carolina)
For more information on the LTC Falls Data Warehouse please contact Dr. Howard Degenholtz.
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Aging Epidemiology Studies Databases
Rich databases available for use by Pepper investigators.
Health ABC - PI Dr. Anne Newman
Study of Osteoporatic Fractices (SOF) - PI Dr. Jane Cauley
MrOS: The Osteoporotic Fractures in Men Study - PI Dr. Jane Cauley
Cardiovascular Health Study (CHS) - PI Dr. Anne Newman
Field Centers - PI Dr. Anne Newman
Cardiovascular Health Study All Stars (CHS All Stars) - PI Dr. Anne Newman
Look AHEAD Action for Health in Diabetes - PI Dr. John Jackicic
Long Life Family Study - PI Dr. Anne Newman
Study of Energy and Aging - PI Dr. Anne Newman
Lifestyle Interventions and Independence for Elders (LIFE) Study - PI Dr. Anne Newman
The Testosterone Trial - PI Dr. Jane Cauley
ZEST: Zoledronic acid in frail Elders to Strengthen bone - PI Dr. Susan Greenspan
Center for Aging and Population Health - PI Dr. Anne Newman
Prevention Research Center - PI Dr. Anne Newman
- The Health ABC Study was designed to characterize the extent of change in body composition in older men and women, identify clinical conditions accelerating these changes, and examine the health impact of these changes on strength, endurance, disability, and weight-related diseases of old age. The study population consists of 3,075 persons age 70-79 at baseline with about equal numbers of men and women. Thirty-three percent of the men are African-Americans as are 46% of the women. All persons in the study were selected to be free of disability in activities of daily living and free of functional limitation (defined as any difficulty walking a quarter of a mile or any difficulty walking up 10 steps without resting) at baseline. Hospitalization was verified by linking with Centers for Medicare and Medicaid Services (CMS). Deaths were verified through matching with the National Death Index. Over the 14 year span of the study there have been few withdrawals.
- The multi-center Study of Osteoporotic Fractures (SOF) has 20 years of prospective data about osteoporosis that has served as the basis for many findings about osteoporosis and aging in women > age 65. SOF is a multi-center prospective observational study of a cohort of 10,366 women age 65 or older who were recruited from four metropolitan areas in the United States: Baltimore, Pittsburgh, Minneapolis and Portland (the original cohort of 9704 was enhanced by the addition of 662 African American women in 1997-98). The primary purpose of SOF has been to describe the risk factors for osteoporotic fractures. Participants were initially recruited from mailings to age-eligible women identified from community-based listings, such as memberships of large health maintenance organizations. In addition to adjudication of fractures, SOF has tracked cases of incident breast cancer, and total and cause-specific mortality. The data include serial measures of bone mineral density, measurements of sex and calcitropic hormones, tests of strength and function, cognitive exams, sleep measurements, use of medication, health habits and much more. Most data are available in the current release. This database is a rich source of mobility, falls, and fracture data, relevant to our Pepper theme.
- The Osteoporotic Fractures in Men Study (MrOS) is a multicenter prospective study of risk factors for vertebral and all nonvertebral fractures in older men. Roughly 5995 men age 65 years or older were recruited from March 2000 to April 2002 from 6 communities including Pittsburgh. This prospective, observational study is designed to determine risk factors for osteoporosis and fractures, to understand age-related medical conditions and risk factors including, but not limited to fall risk. Serum, urine and DNA are collected and stored for future analyses directed by emerging issues in the fields of aging and skeletal health. To elucidate similarities and differences in osteoporosis determinants among men and women, MrOS participants will be compared to women in the Study of Osteoporotic Fractures. Dr. Cauley is the site PI for the study. MrOs is a rich database for studies of falls, fractures, body composition and other areas relevant to our theme.
- The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing.
- In June 1990, four Field Centers completed the recruitment of 5201 participants. Between November 1992 and June 1993, an additional 687 African Americans were recruited using similar methods. The Field Centers included; Sacramento County, Sacramento, CA - University of California, Davis; Washington County, Hagerstown, MD - Johns Hopkins University; Forsyth County, Winston-Salem, NC - Wake Forest University School of Medicine; Pittsburgh, PA - University of Pittsburgh. The baseline examinations consisted of a home interview and a clinic examination that assessed not only traditional risk factors but also measures of subclinical disease, including carotid ultrasound, echocardiography, electrocardiography, and pulmonary function. Between enrollment and 1998-99, participants were seen in the clinic annually, and contacted by phone at 6-month intervals to collect information about hospitalizations and potential cardiovascular events. Major exam components were repeated during annual follow-up examinations through 1999. Cranial MRI scans, retinal photography, and tests of endothelial function were added as new components. Standard protocols for the identification and adjudication of events were implemented during follow-up. The adjudicated events are CHD, angina, heart failure (HF), stroke, transient ischemic attack (TIA), claudication and mortality. Since 1999, participants have been contacted every 6 months by phone, primarily to ascertain health status for events follow-up. This database has been a rich source of data for our Pepper Investigators, RCDC members, and provides ongoing collaborations with other Pepper OAICs.
- Cardiovascular Health Study All Stars (CHS All Stars) is an NIH funded ancillary study of the Cardiovascular Health Study (CHS) designed to evaluate healthy aging and longevity in CHS. CHS began in 1988 as a longitudinal, observational, population-based study of the onset, progression, and course of heart disease and stroke in the elderly. Participating Field Centers are located in Pittsburgh, PA, Hagerstown, MD, Sacramento, CA, and Winston-Salem, NC. The CHS All Stars Study focused on reexamining the long term survivors of CHS to determine the likelihood of maintaining function later in life. As a prospective cohort study, the CHS All Stars Study will compare surviving CHS participants who have remained functional with those who have died or become disabled. A focus will be placed on the oldest CHS survivors to determine whether age related biological factors will be long-term predicators of functional aging. The functional aging will be assessed through a follow-up exam and at least three years of subsequent six month interval telephone contacts. The CHS All Stars database has been utilized by Pepper Investigators (Newman, DeVallejo, Studenski).
- Look AHEAD Action for Health in Diabetes is a randomized controlled clinical trial that is designed to characterize the impact on several health outcomes of an intervention program designed to produce weight loss. The primary study objective is to determine whether such a program is effective in reducing the number of serious cardiovascular disease events in a cohort of overweight adults with type 2 diabetes. The Coordinating Center serves as the bone density quality assurance group for the study. Hip, spine, and whole body scans are sent to us for quality and technical review and central databasing. Dr. John Jakicic, Director of our Physical Activity and Weight Management Center, mentor for RCDC trainee Dr. Bethany Barone-Gibbs are investigators in this study.
- Long Life Family Study (LLFS), established in 2005 in response to an NIA RFA, enrolled families enriched for exceptional longevity (EL), to discover factors that contribute to healthy aging and survival. From 2006 to 2009, LLFS enrolled 539 siblings (G1), their offspring (G2) and spouses (total 4,953) from three US field center (University of Pittsburgh, Boston University and Columbia University) plus one field center in Denmark. There are 159 families with 1310 individuals enrolled though the Pittsburgh Field Center. Comparison with a referent cohort reveals that LLFS families have strong exceptional clustering of EL. The G2 offspring have a variety of Healthy Aging Phenotypes (HAPs), defined as an unusually low age-specific prevalence of one or more specific conditions or risk factors or a high level of physical or cognitive function for age, compared to population-based cohorts suggesting enrichment of shared (possibly genetic) protective effects in LLFS families. In the second funding period (2010-2013), we conducted a 2.5 million SNP GWAS (dbGaP phs000397); developed a high-throughput technique and sequenced ~450 candidate genes and replicated many variants and found additional ones associated with Healthy Aging Phenotypes (HAP) and longevity. 54% of LLFS G1 and 92% of G2 remain alive. Participant retention has been 94%. The next phase of the LLFS is to conduct a second in-person examination to prospectively study rates of change in HAPs with age and identify genetic and other factors contributing to HAPs and longevity. We will characterize individual longitudinal patterns of HAPs to identify subgroups showing similar patterns and exceptional phenotypes. We will test whether these HAPs are heritable, and test for differences with internal and external referent groups. Other aims include identifying genes/variants associated with cross-sectional and longitudinal phenotypes using a) Whole Exome Sequencing to comprehensively search for coding variants associated with HAPs and EL and b) Targeted Regulatory Sequencing of regions under linkage peaks for HAPs in selected families showing the strongest linkage evidence; and to replicate our genetic and epidemiological findings in other aging study cohorts. This study could lead to the discovery of pathways and potential therapeutic/prevention targets affecting HAPs and EL. Dr. Anne Newman, Co-leader of the Pittsburgh Pepper is a site-PI.
- Study of Energy and Aging (SEA) is a cross-sectional, observational study of 38 men and women ages 70-89 years with a wide range of mobility, examined in 2011. To lay the foundations for future longitudinal studies of energy production, disability, and fatigue, SEA tested several novel measurements of mitochondrial function, in-vivo ATP production, and other standard myocellular features for correlations with mobility, exertional fatigue during walking, and leg muscle strength and mass and establish their intra-subject reproducibility. SEA also aimed to develop standardized procedures and quality control of these measurements for use in future longitudinal and multi-center studies, and SEA created a unique resource of muscle biopsy tissue in well-characterized elderly people. All subject recruitment and data collection occurred at the clinical center at the University of Pittsburgh. Nancy Glynn, PhD, an RCDC member is Co-Investigator on this trial.
- Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multi-center randomized controlled trial designed to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older adults who are followed for an average of 2.7 years. The primary aim is to assess the long-term effects of the proposed interventions on the primary outcome of major mobility disability, defined as inability to walk 400 m. Secondary aims focus on assessing the relative effects of the interventions on the following outcomes: cognitive function; serious fall injuries; persistent mobility disability; the combined outcome of major mobility disability or death; disability in activities of daily living; cardiovascular and pulmonary events; and cost-effectiveness. Tertiary aims relate to assessing the relative effects of the interventions on (a) the combined outcome of mild cognitive impairment or dementia and (b) physical performance within pre-specified subgroups defined on the basis of race, gender and baseline physical performance. The proposed trial will provide definitive evidence regarding whether lifestyle modification interventions are effective and practical for preventing major mobility disability. Eight sites around the country participate in the LIFE study. Dr. Anne Newman, Co-leader of the Pittsburgh Pepper is a site-PI and chair of the LIFE ancillary study committee and provides access to the study for our investigators.
- The Testosterone Trial is a clinical research trial to determine if testosterone treatment of men aged 65 and older will help their walking, vitality, sexual function, memory, bone density, blood count, and cardiovascular risk. This trial, called The Testosterone Trial, or TTrial, will be conducted in 800 men in 12 cities across the United States. The overall goal of The Testosterone Trial is to test the hypothesis that testosterone treatment, compared to placebo treatment, of men who are 65 years or older and have unequivocally low serum testosterone concentrations will improve their physical function, sexual function, vitality, cognitive function, and low hemoglobin concentration, as well as decrease risk factors for cardiovascular and diabetes. Dr. Greenspan is a co-investigator in this trial along with the site-PI, Dr. Jane Cauley. Many of the outcomes, including the Bone Trial will be a rich source of data for our investigators.
- ZEST: Zoledronic acid in frail Elders to Strengthen bone (ZEST) is designed to determine if a single dose of an intravenous bisphosphonate is safe and effective for osteoporosis prevention in frail elderly. Approximately 80% of residents in long term care institutions have osteoporosis and the incidence of hip or vertebral fractures is 8-9 times that in the community. The investigators postulate that in frail, institutionalized elderly women, a single dose of intravenous zoledronic acid will: 1) be efficacious as demonstrated by maintenance or improvements in conventional bone mass and reductions in bone turnover, 2) be safe and feasible, 3) provide estimates for fracture reduction in this cohort for use in planning a future study. To address these hypotheses, they enrolled 180 institutionalized women in a 2-year, calcium-vitamin D controlled, randomized, double-blind trial of a single dose of intravenous bisphosphonate, zoledronic acid. Participants reside in the long-term care settings associated with the Division of Geriatric Medicine, University of Pittsburgh. Outcome measures include bone density of the spine and hip, markers of bone turnover, vertebral x-rays to assess for fractures, body composition (muscle and fat by DXA), functional assessments, gait and adverse events. This study will provide the necessary data on the efficacy and safety of osteoporosis treatment in elderly women with a feasible single dose of intravenous antiresorptive agent, and will lay the foundation for a future multicenter fracture reduction trial in this cohort. Dr. Greenspan is the PI of this trial and a pilot study used to provide body composition data for the FNIH (Foundation NIH) Sarcopenia phase 2 project.
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