R01AG070004

Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement

Total Knee Replacement (TKR) utilization continues to increase, placing a substantial burden on the economy. As patients live longer with TKR, it is essential to identify strategies that will maximize long-term functional outcomes and promote health-related quality of life and independence as adults age after surgery.

The majority of TKR patients meet criteria for overweight/obesity and remain physically inactive after surgery, both of which heighten the risk of poor functional outcomes and disability. Furthermore, most patients will actually gain weight within two years after surgery. Patients after TKR are also at an increased risk of death from cardiovascular and mental diseases.

Promoting weight management may be an effective strategy to improve long-term functional and physical activity outcomes after TKR, reduce the risk of disability and death from cardiovascular and mental diseases, and improve the value of the costly surgery.

We propose to examine the effectiveness of a patient-centered (PACE) weight loss program in adults after TKR in a fully-powered, two-arm randomized controlled trial. Patients (N=250) will be randomized to receive either (1) PACE weight loss program or (2) Chronic Disease Self-Management (CDSM) control group.

PACE participants will start the patient-centered program 12 weeks after TKR and continue for 12 months. PACE is tailored to the patients' needs and unique barriers to diet and physical activity. PACE focuses on reducing caloric intake and increasing physical activity (aerobic and resistance) to facilitate a weight loss of at least 7% of initial body weight.

Coaching calls with a trained behavioral interventionist will occur weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12. No coaching will occur during the maintenance phase (months 13-18). CDSM will receive a self-directed version of the program and monthly calls on topics not related to study outcomes.

Data collection will occur at baseline (12 weeks after surgery), 6 months (end of intensive intervention), 12 months (end of treatment), and 18 months (maintenance). Assessments will include measures of weight, secondary outcomes (e.g., physical activity, pain, function), and potential mediators from our conceptual model (e.g., adherence, self-efficacy, autonomy, competence).

Data related to the cost of implementing the PACE weight loss intervention relative to control will also be collected to examine the cost-effectiveness of reducing weight on patient outcomes. The primary outcome is weight change at 6 months.

The expected outcome from this study is to determine the effectiveness and long-term maintenance of a refined patient-centered weight loss program tailored specifically for adults after TKR. If PACE is effective at improving short- and long-term outcomes and is found to be cost-effective, orthopedic centers and/or insurance companies could consider offering this program to TKR patients, offering significant benefits to the rising number of adults undergoing TKR.

University Of South Carolina

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]

Columbia, South Carolina 292083403 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the total obligations have increased 400% from $628,486 to $3,144,626.