R01AG071807

The Preventable Physical Performance Ancillary Study - Project Summary/Abstract

Aging is associated with significant declines in muscle mass, strength, and physical performance, which often lead to disability, loss of independence, and adverse clinical outcomes including multimorbidity and mortality. At present, healthcare providers have no therapeutic options to offer their patients to slow aging-related declines in physical function.

Importantly, evidence is emerging that statins could be an effective treatment for preserving physical function by preventing disabling events such as stroke, heart failure, or myocardial infarction. In addition, statins have pleiotropic properties including anti-inflammatory, anti-oxidant, and immunomodulatory effects, which may slow or prevent aging-related declines in physical function. However, reports of muscle pain and weakness in patients on statins have led to a significant number of patients discontinuing statins.

Thus, the proposed study is critical to establish whether statins may help to preserve physical function and independence in older adults, or whether statin-associated muscle symptoms portend a statin-related decline in physical function. The Preventable Trial (U19 AG065188) provides an ideal opportunity to definitively determine the effect of statins as a treatment for aging-related declines in physical function.

Preventable is a placebo-controlled pragmatic clinical trial designed to investigate whether randomization to a statin can prevent dementia and prolong disability-free survival in 20,000 participants aged 75+ years without clinically evident coronary heart disease. While the Preventable Trial will help clarify the effects of statins on self-reported disability, the proposed ancillary study will extend and validate the physical disability data by investigating the effects of statins on changes in physical performance, which are typically observed earlier in the trajectory of functional decline and may be a more sensitive marker for the effects of statin.

To determine if statins affect longitudinal change in physical performance, the proposed ancillary study will add the Short Physical Performance Battery (SPPB), a validated measure of lower-extremity performance comprised of balance tasks, a 4-M walk, and repeated chair stand test, over 3 years of follow-up in 2,500 Preventable participants (1,250 per intervention arm). Self-reported information on patient-centered outcomes relevant to physical function including statin-associated muscle symptoms, fatigue, and pain will also be collected.

The specific aims of this ancillary study are to:
1) Determine whether randomization to statin slows the aging-related decline in usual gait speed;
2) Determine whether randomization to statin slows aging-related declines in lower-extremity function (SPPB score) and strength (chair rise time); and
3) Explore whether randomization to statin is associated with self-reported statin-associated muscle symptoms, fatigue, and pain.

By leveraging the rich resources and infrastructure of Preventable, this timely and cost-effective study provides a unique opportunity to significantly expand the scope and impact of the parent trial on self-reported physical disability by determining the therapeutic potential of statins to slow aging-related declines in physical performance.

Wake Forest University Health Sciences

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Winston Salem, North Carolina 27157 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Amendment Since initial award the End Date has been extended from 05/31/26 to 05/31/28 and the total obligations have increased 477% from $527,282 to $3,040,350.