Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Sedentary behaviour as assessed by ActivPAL™
研究概览
简要总结
This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in rheumatoid arthritis. To this aim, we will conduct a 4-month parallel-group randomized controlled trial aiming to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity in rheumatoid arthritis. Additionally, a sub-sample of patients will complete a randomised cross-over study aiming to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women diagnosed with rheumatoid arthritis
排除标准
- •any physical disabilities that preclude physical exercise testing
- •participation in structured exercise training programs within the last 12 months
- •unstable dose of disease modifying drugs, including biological therapy, in the last 3 months prior to and during the study
结局指标
主要结局
Sedentary behaviour as assessed by ActivPAL™
时间窗: 4 months
次要结局
- Disease activity as assessed by DAS28(4 months)
- Drug doses(4 months)
- Pain as assessed by the Visual Analogic Scale(4 months (RCT) and 8 hours (crossover))
- Blood pressure(4 months (RCT) and 8 hours (crossover))
- Inflammatory cytokines(4 months (RCT) and 8 hours (crossover))
- Aerobic conditioning as assessed by a cardiopulmonary test(4 months)
- Muscle function as assessed by a battery of tests(4 months)
- Insulin sensitivity as assessed by surrogates of insulin sensitivity(4 months (RCT) and 8 hours (crossover))
- RT-PCR(4 months (RCT) and 8 hours (crossover))
- Physical activity levels as assessed by ActiGraph GT3X®(4 months)
- Fatigue as assessed by the Fatigue Severity Scale(4 months)
- Heart rate responses to exercise as assessed by a cardiopulmonary test(4 months)
- Muscle sympathetic nerve activity as assessed by microneurography(4 months)
- Vascular function and structure as assessed using a high-resolution ultrasound machine(4 months)
- Quality of life as assessed by the SF-36 questionnaire(4 months)
- Western blotting(4 months (RCT) and 8 hours (crossover))
- RNA sequencing(4 months (RCT) and 8 hours (crossover))
- Body composition as assessed by densitometry (DEXA)(4 months)
- Physical functioning as assessed by a Health Assessment Questionnaire(4 months)
- Lipid profile(4 months (RCT) and 8 hours (crossover))
- Lipidomics(4 months (RCT) and 8 hours (crossover))
研究者
Bruno Gualano
Professor
University of Sao Paulo