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.

总膝盖置换（TKR）的利用率继续增加，将大量的伯恩置于 经济。随着患者使用TKR的寿命更长，必须确定将最大化长期的策略 随着成年人的年龄，功能结果并促进与健康相关的生活质量和独立性。 大多数TKR患者符合超重/肥胖的标准，手术后身体不活跃， 两者都会增加功能结果和残疾的风险。此外，大多数患者实际上会 手术后两年内增加体重。 TKR后的患者也有增加死亡风险 心血管和精神疾病。促进体重管理可能是改进的有效策略 TKR后的长期功能和体育锻炼结果，降低了残疾和死亡的风险 心血管和精神疾病，并提高昂贵手术的价值。 我们建议检查成人以患者为中心（PACE）减肥计划的有效性 TKR在全功率，两臂随机对照试验中。患者（n = 250）将被随机分为 接受（1）速度减肥计划或（2）慢性疾病自我管理（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是针对患者的需求和饮食和体育锻炼的独特障碍量身定制的。步伐专注于 减少热量摄入量并增加体育锻炼（有氧和抵抗力），以促进AT的体重减轻 最初体重的7％。训练有素的行为干预主义者的教练电话将每周发生 1-4个月，每两周在5-6个月，每月在7-12月。在 维护阶段（13-18月）。 CDSM将获得该程序的自我指导版本和每月 呼吁与研究结果无关的主题。数据收集将在基线（手术后12周）发生，6 月份（密集干预的结束），12个月（治疗结束）和18个月（维护）。 评估将包括体重的度量，次要结果（例如体育活动，疼痛，功能）和 来自我们概念模型的潜在介体（例如，遵守，自治，自主权，能力）。数据 还将收集与实施步伐减肥干预措施相对于控制的成本有关的 检查减轻患者预后体重的成本效益。主要结果是体重 6个月的变化。 这项研究的预期结果是确定的有效性和长期维护 TKR后专门针对成人量身定制的精致以患者为中心的减肥计划。如果步伐有效 改善短期和长期结果，发现具有成本效益的骨科中心和/或 保险公司可以考虑向TKR患者提供此计划，从而为 成年人的数量增加了TKR。