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

• 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
• 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' 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

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，给患者带来了巨大的负担。 经济由于TKR患者的寿命更长，因此必须确定最大限度地提高长期生存率的策略。 功能结果和促进健康相关的生活质量和独立性作为成年人手术后的年龄。 大多数TKR患者符合超重/肥胖的标准，并且在手术后保持身体不活动， 这两者都增加了功能结果差和残疾的风险。此外，大多数患者实际上 手术后两年内体重增加。全膝关节置换术后患者的死亡风险也增加， 心血管和精神疾病。促进体重管理可能是一个有效的策略，以改善 全膝关节置换术后的长期功能和身体活动结果，降低因全膝关节置换术而残疾和死亡的风险 心血管和精神疾病，并提高昂贵的手术价值。 我们建议检查以患者为中心（PACE）减肥计划在成人中的有效性 在一项全把握度、两组随机对照试验中，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针对患者的需求以及饮食和体力活动的独特障碍而量身定制。PACE专注于 减少热量摄入和增加体力活动（有氧和阻力），以促进体重减轻 体重的7%以上。在此期间，每周都会与训练有素的行为干预专家进行电话辅导。 1-4个月，5-6个月期间每两周一次，7-12个月期间每月一次。在此期间不会进行辅导， 维持阶段（13-18个月）。CDSM将收到该计划的自我指导版本， 呼吁与研究结果无关的主题。数据收集将在基线（术后12周）、6 3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、次要结局（例如，身体活动、疼痛、功能），以及 来自我们的概念模型的潜在介体（例如，坚持、自我效能、自主性、能力）。数据 还将收集与实施PACE减肥干预相对于对照组的成本相关的信息 以检查减轻体重对患者结局的成本效益。主要结果是体重 6个月后的变化 本研究的预期结果是确定 一个完善的以患者为中心的减肥计划，专门为TKR后的成年人量身定制。如果PACE有效， 改善短期和长期结果，并发现具有成本效益，骨科中心和/或 保险公司可以考虑为TKR患者提供该计划，为患者提供显著的利益。 越来越多的成年人接受TKR。