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

体力活动和减肥可改善全膝关节置换术后的功能和疼痛

基本信息

批准号：
10659134
负责人：
Christine Ann Pellegrini
金额：
$ 59.34万
依托单位：
UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-15 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10659134
关键词：
2 arm randomized control trial Adherence Adult Aerobic Age Alzheimer&apos s Disease Behavioral Body Weight Body Weight Changes Body Weight decreased Calories Cardiovascular Diseases Cardiovascular system Cessation of life Chronic Disease Competence Control Groups Cost Analysis Data Data Collection Dementia Diet Disease Effectiveness Elderly Energy Intake Fright Goals Health Educators Health Promotion Injury Insurance Intervention Knee Osteoarthritis Link Maintenance Measures Mediator Modeling Monitor Obesity Operative Surgical Procedures Orthopedics Outcome Outcome Study Overweight Pain Participant Patient Preferences Patient Self-Report Patient-Focused Outcomes Patients Persons Phase Physical Function Physical activity Pilot Projects Productivity Psyche structure Quality-Adjusted Life Years Randomized Reporting Resistance Risk Risk Reduction Self Direction Self Efficacy Self Management Surgeon Telephone Testing Training Walking Weight Weight Gain Weight maintenance regimen Weights and Measures Work age group aging population comparison control cost cost effective cost effectiveness design disability disability risk effectiveness evaluation experience functional disability functional improvement functional outcomes health care service utilization health related quality of life improved knee replacement arthroplasty mortality mortality risk patient oriented physical inactivity physical therapist primary outcome programs psychosocial secondary outcome telephone coaching weight loss intervention weight loss program

项目摘要

Total knee replacement (TKR) utilization continues to increase, placing 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. Further, 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 underdoing TKR.

全膝关节置换术（TKR）的使用率持续增加，给患者带来了沉重的负担由于接受 TKR 的患者寿命更长，因此必须确定能够实现长期效益最大化的策略。随着成年人手术后年龄的增长，功能结果并提高与健康相关的生活质量和独立性。大多数 TKR 患者符合超重/肥胖标准，并且术后仍保持身体不活动状态，此外，这两者都会增加功能不良和残疾的风险。手术后两年内体重增加的患者因 TKR 死亡的风险也增加。促进体重管理可能是改善心血管和精神疾病的有效策略。 TKR 后的长期功能和身体活动结果，降低因残疾和死亡的风险心血管和精神疾病，并提高昂贵的手术的价值。我们建议研究以患者为中心 (PACE) 的成人减肥计划的有效性在一项全功效双臂随机对照试验中进行 TKR 后，患者 (n=250) 将被随机分配至接受 (1) PACE 减肥计划或 (2) 慢性病自我管理 (CDSM) 对照组。 PACE 参与者将在 TKR 后 12 周开始以患者为中心的计划，并持续 12 个月。 PACE 是根据患者的需求量身定制的，PACE 重点关注饮食和身体活动的独特障碍。减少热量摄入并增加体力活动（有氧运动和阻力），以促进体重减轻在此期间，每周将与训练有素的行为干预专家进行至少 7% 的指导。第 1-4 个月，第 5-6 个月每两周一次，第 7-12 个月每月一次。维护阶段（第 13-18 个月）CDSM 将收到该程序的自我指导版本和每月一次。与研究结果无关的主题的电话收集将在基线（手术后 12 周）6 进行。个月（强化干预结束）、12 个月（治疗结束）和 18 个月（维持）。评估将包括体重测量、次要结果（例如体力活动、疼痛、功能）和我们的概念模型中的潜在中介因素（例如，依从性、自我效能、自主性、能力）。与控制相关的实施 PACE 减肥干预的成本也将被收集检查减肥对患者结果的成本效益。主要结果是体重。 6个月时改变。这项研究的预期结果是确定有效性和长期维护如果 PACE 有效，则专为成人量身定制以患者为中心的精细减肥计划。改善短期和长期结果，并且被发现具有成本效益，骨科中心和/或保险公司可以考虑向 TKR 患者提供此计划，为患者带来显着的好处未进行 TKR 的成年人数量不断增加。