This Core – led by Elena Volpi, MD, PhD, FGSA, Dean Kellogg, MD, PhD, and Tiffany Cortes, MD – provides critical infrastructure, knowledge, innovative methodologies, technical support, and education to assists basic and clinical researchers in developing and conducting rigorous and appropriately powered clinical studies that will lead to innovative approaches to improve the health and functional independence of all older adults.
Specific Aims of the CRRC:
- Catalyze innovative clinical research by providing expertise for investigators to plan and design novel clinical trials that rigorously test geroscience interventions to improve health, function and independence.
- Enhance the infrastructure to support recruitment, tracking, and retention of diverse cohorts of older adults for San Antonio Pepper Center projects, Pepper Centers Network studies, and other multisite clinical studies on aging.
- Provide core services, including standardized health screenings, functional phenotyping, nutrition and body composition assessments, exercise testing and training, PK/PD testing, and tissue sampling.
- Monitor and support compliance of the San Antonio Pepper Center studies with regulations governing clinical investigations with human subjects and ensure participant safety through our Data Safety and Monitoring Board.
- Provide education and training in clinical trials, recruitment, retention, and study procedures.
- Develop and disseminate novel methods to improve recruitment and retention of older adults from underprivileged and understudied groups, especially Hispanic, in geroscience trials.
Types of Studies Supported
- Phase 1 clinical trials of new compounds not yet tested in older adults (pharmacokinetics/pharmacodynamic, toxicity, feasibility, effect size).
- Phase 2 clinical trials of compounds to probe mechanisms important in aging biology and provide proof-of-concept on agents with potential to enhance healthspan and improve function.
- Phase 3 and 4 multicenter trials
- Implementation studies in clinical practice
- Aging-modulating lifestyle interventions to determine the impact on the biological mechanisms of aging and functional independence
- Cohort studies to identify and select important outcomes, surrogate endpoints, and predictive biomarkers of healthspan and function to guide geroscience trials.
CORE SERVICES
STUDY DESIGN
- Planning and design of studies and protocols
REGULATORY SUPPORT
- IRB
- FDA/IND
- ClinicalTrials.gov
- CROMS
TESTING SUPPORT
- Screening
- Assessments
- Drug dispensing
- Timed blood and tissue collection
- Monitoring
- Documentation
- Procedures and Assessments
GENERAL EVALUATION:
- Vital signs
- Anthropometry (Height, Body Mass, Abdominal Circumference)
- Activities of Daily Living and Instrumental Activities of Daily Living assessments (See GRAF-The Lawton Instrumental Activities of Daily Living Scale)
- Veterans VR-36 Health Status Questionnaire (See VR-36 form and How to score VR-36; KAZIS-The Veterans SF-36 Health Status Questionnaire; BRAZIER-Validating the SF-36 health survey questionnaire-new outcome measure for primary care)
- Clinical history
- Physical Exam
- Constipation by PAC-SYM score (See PAC-SYM form; NERI-Confirmatory factor analysis of the patient assessment of constipation-symptoms (PAC-SYM) among patients with chronic constipation)
PHYSICAL PERFORMANCE EVALUATION
- Hand Grip strength (See GRIP STRENGTH instructions + score sheet; TAEKEMA-Handgrip strength as a predictor of functional, psychological and social health)
- Isokinetic/isometric strength with Biodex dynamometry
- 1 Repetition Maximum (various muscle groups)
- Cardiopulmonary test, VO2 max/peak (treadmill, cycle)
- Gait Speed (10-foot, 15-foot, 4-meter, 40-feet) or 6 Minute Walk Test (See GAIT SPEED instructions + score sheet; 6 Minute Walk Test Instructions + Score Sheet; ATS Statement- Guidelines for the Six-Minute Walk Test)
- Short Physical Performance Battery (SPPB-three tests of physical function: habitual walking speed; time to rise from a chair and sit down five times (chair stands; and standing balance) (See Short Physical Performance Battery Protocol and Score Sheet)
- Frailty assessment (Fried phenotype and deficit accumulation)
- Markless biomechanics
EXERCISE TRAINING
- Resistance exercise
- Aerobic exercise
ACTIVITY & SLEEP
- Actigraph activity and sleep monitoring (Actigraph, LLC)
- StepWatch Activity Monitoring
- FitBit
- Minnesota Leisure Time Activity Questionnaire (MLTA-An interviewer-administered questionnaire to evaluate energy expenditure in leisure time physical activity) (TAYLOR-A questionnaire for the assessment of leisure time physical activities
NUTRITION
- ASA24
- myfitnesspal
- Diet History Questionnaire
- Food diaries
- Three Factor Eating Questionnaire
METABOLISM
- Oral glucose tolerance testing
- Meal tolerance testing
- Glucose clamp (euglycemic, isoglycemic, hyperglycemic)
- Indirect calorimetry
BODY COMPOSITION
COGNITION AND AFFECT EVALUATION
- MMSE, SLUMS or MoCA-global cognitive assessment (See SLUMS and MoCA forms; BUCKINGHAM-Comparing the cognitive screening tools-MMSE and SLUMS)
- EXIT25 or CLOX 1 and II-Executive function (See EXIT25 instructions and EXIT25-Executive Interview 25 form; CLOX test form; ROYALL-Clock drawing is sensitive to executive control-a comparison of six methods)
- Texas Assessment of Processing Speed (TAPS)-uses sorting and categorization as test of Executive function; has alternative forms to minimize learning effects with repeated administration (See TAPS instructions, A+B forms, and A+B scoring sheets)
- Geriatric Depression Scale-depression screen (See GDS-Short Form; GREENBERG-The geriatric depression scale (GDS))
- Centers for Epidemiologic Studies Depression Scale (CES-D)
CARDIOVASCULAR FUNCITON
- Echo-Doppler
- Flow mediated dilation
- Near infrared spectroscopy
- Definity microbubbles
- Aortic Pulse Wave Velocity-compliance assessment (noninvasive) (See BOUTOUYRIE-Assessment of pulse wave velocity)
- Resting and continuous EKG monitoring during exercise
BIOSPECIMEN COLLECTION
- Blood
- Skeletal muscle
- Skin
- Adipose tissue
- Cerebrospinal fluid
CLINICAL LABS
- CBC, chemistry, HbA1c, coagulation, urinalysis
DATA MANAGEMENT (IN COORDINATION WITH BIRC)
- REDCap database design
- Data entry
- Generation of reports
ADVANCED IMAGING
- Ultrasoud imaging
- Liver elastography
- MRI spectroscopy (coordination with institutional core)
- PET (coordination with institutional core)
THE SOUTH TEXAS AGING REGISTRY AND REPOSITORY (STARR)
The South Texas Aging Registry and Repository (STARR) is a database and specimen resource of adult subjects from the South Texas community. De-identified repository data and samples are available to qualified investigators for future studies related to aging. Investigators may contribute de-identified specimens and data to the repository.