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）是一种全身性自身免疫性疾病，其特征在于显著的 这种炎症在美国影响了多达150万人。虽然SLE患者的超额死亡率有所下降， 自20世纪70年代以来，在这一人群中发病的主要原因是慢性衰弱性疲劳 这大大降低了生活质量，增加了工作残疾和相关医疗保健的风险 成本在SLE患者的管理中，一个迫切的、未得到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显示， 有氧运动可以提高生活质量，减少疲劳，但研究如何最好地促进 身体活动（PA）有限。在考虑其他生活方式行为时，关于 饮食，能量平衡和/或营养密度，但饮食干预一直是有利的 与管理其他疾病中的疲劳相关（例如，心血管疾病和年龄相关功能 下降）。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），以前是狼疮活动和营养试验， 激励和更新（ANTLER），规划补助金（U34 AR 064513）。LIFT是一项为期12个月的III期随机， 平行组、单盲、双臂试验，旨在比较动机性访谈的有效性 程序干预与患者教育程序控制，以减少狼疮患者的疲劳。 每组有6个月的干预和6个月的随访。个性化定制的生活方式咨询， 动机性访谈和6个月的小组支持会议旨在增加身体活动， 改善干预组的饮食质量。对照组包括！四个电话 与参与者就有关研究的问题或小组会议，每个持续约10-15 5分钟和6个月的小组教育会议，重点是SLE症状管理。使用经验证的 在SLE患者中进行的LIFT随机试验的前两个具体目标是：1）实施 并使用疲劳量表评估LIFT干预对自我报告的疲劳测量的影响。 严重程度评分（FSS）作为主要结局; 2）评价LIFT干预对 PA的客观指标，平均每日非久坐分钟数，定义为轻度分钟/天和中度分钟- 活力分钟/天，通过三轴加速计客观测量，作为次要结局。第三 一个具体的目的是探索性地评估对LIFT饮食干预的依从性， 以健康饮食指数量度的建议饮食模式及食物组别的密度及摄入量 (HEI)，从营养数据研究系统（NDSR）计算的综合评分， 饮食回忆电脑系统