Lupus Intervention Fatigue Trial (LIFT)

狼疮干预疲劳试验 (LIFT)

• 批准号: 10245263
• 负责人: Linda S. Ehrlich-Jones
• 金额: $ 60.64万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10245263
• 关键词: Accelerometer; Adherence; Aerobic Exercise; Affect; Behavior; Cardiovascular Diseases; Cessation of life; Chronic; Counseling; Data; Diagnosis; Diet; Dietary Intervention; Disease; Eating; Education; Excess Mortality; Exercise; Fatigue; Food; Grant; Health; Health Care Costs; Health Personnel; Health Promotion; Healthy Eating; Hour; Individual; Inflammation; Information Systems; Intake; Intervention; Intervention Trial; Interviewer; Life Style; Literature; Lupus; Measurement; Measures; Mediating; Modeling; Monitor; Morbidity - disease rate; Nutrient; Outcome; Outcome Assessment; Oxygen; Participant; Patient Self-Report; Patients; Pattern; Persons; Phase; Physical activity; Population; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Risk; Severities; Single-Blind Study; Sum; Support Groups; Support System; System; Systemic Lupus Erythematosus; Telephone; Visit; Work; age related; arm; compare effectiveness; computerized; density; design; diabetes prevention program; dietary; disability; effectiveness testing; energy balance; follow-up; functional decline; improved; indexing; instrument; intervention effect; intervention program; meetings; motivational enhancement therapy; nutrition; primary outcome; programs; randomized trial; secondary outcome; symptom management; systemic autoimmune disease; systems research; treatment arm; trial design; two-arm trial

Systemic lupus erythematosus (SLE, lupus) is a systemic autoimmune disease characterized by pronounced inflammation that affects up to 1.5 million people in the US. While excess mortality has decreased in SLE patients since the 1970's, a major ongoing cause of morbidity in this population is chronic, debilitating fatigue that significantly decreases quality of life, and increases risk of work disability and associated health care costs. An urgent, unmet need in the management of patients with SLE is identification of effective strategies to reduce fatigue. Non-pharmacologic interventions have been recommended as valuable approaches for the treatment of fatigue. Preliminary data from lupus patients reported by us and others showed that regular aerobic exercise can improve quality of life and reduce fatigue, but studies examining how to best promote physical activity (PA) are limited. In considering other lifestyle behaviors, there is limited literature on effects of diet, energy balance, and/or nutrient density in SLE patients, but diet intervention has been favorably associated with managing fatigue in other disorders (e.g., cardiovascular disease and age-related functional decline). To study the effects of intervening on these two potential modifiable lifestyle behaviors (PA and diet) we designed the Lupus Intervention Fatigue Trial (LIFT), formerly the Activity and Nutrition Trial in Lupus to Energize and Renew (ANTLER), in planning grant (U34 AR064513). LIFT is a 12-month phase III randomized, parallel group, single blind 2-arm trial designed to compare the effectiveness of a motivational interviewing program intervention versus a patient educational program control to reduce fatigue in persons with lupus. Each arm has a 6 month intervention with 6 month follow up. Individually tailored lifestyle counseling using motivational interviewing and 6 monthly group support meetings are designed to increase physical activity and improve diet quality in the intervention arm. The control arm includes!four individual phone calls checking in with participants regarding questions about the study or from the group sessions, each lasting about 10-15 minutes and 6 monthly group educational sessions focusing on SLE symptom management. Using validated measures, the first two specific aims for the LIFT randomized trial in persons with SLE are: 1) to implement and evaluate the impact of the LIFT intervention on self-reported measures of fatigue using the Fatigue Severity Score (FSS) as the primary outcome; and 2) to evaluate the impact of the LIFT intervention on objective measures of PA, average daily non-sedentary minutes defined by light minutes/day and moderate- vigorous minutes/day, measured objectively by a triaxial accelerometer as the secondary outcome. The third specific aim is exploratory evaluating adherence to the LIFT dietary intervention as assessed by nutrient density and intake of recommended eating pattern and food groups measured by the Health Eating Index (HEI), a calculated composite score from the Nutrient Data System for Research (NDSR), a validated 24-hour dietary recall computerized system.

系统性红斑狼疮(SLE，Lupus)是一种以明显的系统性自身免疫性疾病为特征的疾病 在美国，影响多达150万人的炎症。虽然系统性红斑狼疮的超额死亡率有所下降 自20世纪70年代以来的患者S，这一人群发病率的一个主要持续原因是慢性、衰弱的疲劳 这大大降低了生活质量，增加了工作残疾的风险和相关的医疗保健 成本。在SLE患者的管理中一个迫切而未得到满足的需要是确定有效的策略来 减少疲劳。非药物干预已被推荐为有价值的治疗方法 疲劳的治疗。我们和其他人报告的狼疮患者的初步数据显示，正常 有氧运动可以提高生活质量和减少疲劳，但研究表明如何才能最大限度地促进 体力活动(PA)有限。在考虑其他生活方式行为时，有关以下影响的文献有限 SLE患者的饮食、能量平衡和/或营养密度，但饮食干预一直是有利的 与处理其他疾病(如心血管疾病和年龄相关功能障碍)的疲劳有关 拒绝)。研究干预对这两种潜在的可改变的生活方式行为(PA和饮食)的影响 我们设计了狼疮干预疲劳试验(LIFT)，以前的狼疮活动和营养试验是为了 激励和更新(鹿角)，在规划拨款(U34 AR064513)中。Lift是一个为期12个月的随机第三阶段， 平行分组、单盲双臂试验，旨在比较激励性访谈的效果 程序干预与患者教育程序对照以减少狼疮患者的疲劳。 每组干预6个月，随访6个月。使用个人定制的生活方式咨询 激励性访谈和每月6次的小组支持会议旨在增加体力活动和 改善干预臂中的饮食质量。控制臂包括！四个单独的电话登记 参与者就有关研究的问题或小组会议提出问题，每次持续约10-15次 每月6分钟的小组教育课程，重点关注SLE症状管理。使用经过验证的 措施，LIFT随机试验在SLE患者中的前两个具体目标是：1)实施 并使用疲劳评估提升干预对自我报告的疲劳测量的影响 作为主要结果的严重程度评分(FSS)；以及2)评估升降机干预对 PA的客观测量，由轻度分钟/天和中等分钟/天定义的平均每日非久坐分钟- 运动分钟/天，由三轴加速度计客观测量，作为次要结果。第三 具体目的是探索性地评估营养素评估的LIFT饮食干预的依从性。 由健康饮食指数衡量的推荐饮食模式和食物类别的密度和摄入量 (HEI)，来自营养研究数据系统(NDSR)的计算综合得分，经过验证的24小时 饮食召回电脑化系统。