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，狼疮）是一种系统性自身免疫性疾病，其特征是明显的 影响美国多达 150 万人的炎症。虽然 SLE 的超额死亡率有所下降 自 20 世纪 70 年代以来，该人群发病的一个主要持续原因是慢性、衰弱性疲劳 这显着降低了生活质量，并增加了工作残疾和相关医疗保健的风险 成本。 SLE 患者管理中一个紧迫的、未满足的需求是确定有效的策略 减少疲劳。非药物干预已被推荐为有价值的方法 治疗疲劳。我们和其他人报告的狼疮患者的初步数据表明，定期 有氧运动可以提高生活质量并减少疲劳，但研究正在探讨如何最好地促进 体力活动（PA）受到限制。在考虑其他生活方式行为时，关于以下行为影响的文献有限 SLE 患者的饮食、能量平衡和/或营养密度，但饮食干预已取得积极进展 与管理其他疾病（例如心血管疾病和与年龄相关的功能障碍）的疲劳有关 衰退）。研究干预对这两种潜在可改变的生活方式行为（体力活动和饮食）的影响 我们设计了狼疮干预疲劳试验 (LIFT)，以前称为狼疮活动和营养试验，以 活力与更新（ANTLER），规划拨款（U34 AR064513）。 LIFT 是一项为期 12 个月的 III 期随机试验， 平行组、单盲双组试验，旨在比较动机访谈的有效性 计划干预与患者教育计划控制以减少狼疮患者的疲劳。 每组都有 6 个月的干预和 6 个月的随访。使用个性化定制的生活方式咨询 动机性访谈和每月 6 次的小组支持会议旨在增加身体活动和 改善干预组的饮食质量。控制臂包括！四个单独的电话登记 与参与者讨论有关研究的问题或小组会议，每次持续约 10-15 分钟和每月 6 次的小组教育课程，重点关注 SLE 症状管理。使用经过验证的 措施，针对 SLE 患者的 LIFT 随机试验的前两个具体目标是：1) 实施 并使用疲劳评估 LIFT 干预对自我报告的疲劳测量的影响 严重程度评分（FSS）作为主要结果； 2) 评估 LIFT 干预对 PA 的客观测量，平均每日非久坐分钟数定义为轻度分钟数/天和中度分钟数 每天的活跃分钟数，通过三轴加速度计客观测量，作为次要结果。第三个 具体目标是探索性评估对 LIFT 饮食干预的依从性（通过营养评估） 根据健康饮食指数衡量的推荐饮食模式和食物组的密度和摄入量 (HEI)，根据研究营养数据系统 (NDSR) 计算出的综合分数，经过验证的 24 小时 饮食回忆计算机系统。