Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus with High Cardiovascular Risk: the Living Well with Lupus Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Risk cardiovascular score
研究概览
简要总结
This research program aims to investigate the clinical, physiological, metabolic and molecular effects of lifestyle change in patients with systemic lupus erythematosus with high cardiovascular risk. This 6-month parallel-group randomized controlled trial aims to investigate the feasibility and efficacy of a newly developed lifestyle change intervention - through recommendations for structured and unstructured physical activity and healthy eating - on increasing physical activity level and improving eating habits. Potential effects of the intervention on cardiovascular and cardiometabolic risk factors, health-related quality of life, symptoms of anxiety and depression, sleep quality and immune function will be investigated. Gold-standard techniques and a variety of analyses will be performed to access the potential mechanisms involved in response to this intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researcher responsible for performing the blood flow measurement will be blinded to the allocation of groups
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 65 years old diagnosed with systemic lupus erythematosus
- •one or more high cardiovascular risk factors
- •SLEDAI score ≤ 4
- •Treatment with prednisone at a dosage <10 mg/d and treatment with hydroxychloroquine in a stable dose
排除标准
- •another rheumatic diseases (except for secondary Sjogren's syndrome)
- •participation in structured exercise training programs and/or prescriptive diets
- •illiterate or with diagnosed cognitive disorders or musculoskeletal impairments that potentially compromise understanding and participation in the intervention
结局指标
主要结局
Risk cardiovascular score
时间窗: 6 months
assessed by measures of five standard variables (HDL cholesterol, triglycerides, fasting blood glucose, waist circumference and blood pressure - average of systolic and diastolic blood pressures). Z-score = \[(50 - HDL cholesterol)/sd + (triglycerides - 150)/ sd\] + \[(fasting blood glucose - 100)/ sd\] + \[(waist circumference - 88)/ sd\] + \[(blood pressure - 115)/ sd\]. Higher score values represent higher risk. \*sd: standard deviation. Higher Z-score represent higher risk.
次要结局
- Erythrocyte sedimentation rate(6 months)
- Body mass index (BMI)(6 months)
- Waist circumference (cm)(6 months)
- Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides(6 months)
- Insulin sensitivity(6 months)
- Systolic and Diastolic blood pressure(6 months)
- Physical activity level(6 months)
- Food consumption(6 months)
- Visceral fat(6 months)
- Peak oxygen consumption, as assessed by a cardiopulmonary exercise test(6 months)
- Endothelial function(6 months)
- Disease activity(6 months)
- Damage index(6 months)
- Global health status(6 months)
- Patients' perceptions of the intervention(6 months)
- Quality of Life assesment assessed by the Short-Form Health Survey-36 (SF36) [followed by its scale information in the Description](6 months)
- Quality of Life assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire ( SLEQOL) [followed by its scale information in the Description](6 months)
- Physical functioning assessed by Timed-Stands(6 months)
- Physical functioning assessed by Timed Up-and-Go(6 months)
- Physical functioning assessed by handgrip test(6 months)
- Fatigue(6 months)
- Anxiety(6 months)
- Depression(6 months)
- Sleep quality assessed by data obtained from Actigraph (Actigraph GT3x)(6 months)
- C-reactive protein (PCR)(6 months)
- Inflammatory markers (blood biochemistry)(6 months)
- Follow-up(Between 7 and 28 months after the completion of the intervention)
研究者
Bruno Gualano
Professor
University of Sao Paulo