Effects of Timed Intensive Light Therapy or Timed Physical Exercise on Markers of Central and Peripheral Circadian Rhythm and on Cardiometabolic Function in Night Shift Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
EuRhythDia is a multicenter, controlled and randomized study. The aim of the study is to investigate the effects of 12 weeks of randomized timed light therapy or timed physical exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral circadian rhythms and cardiometabolic function in healthy night shift workers.
详细描述
Lifestyle interventions have been recognized as important means to prevent and treat cardiometabolic disease. However, compliance of the European population to general recommendations of exercise and weight loss is unsatisfactory. There have been no studies that have attempted to convert the exciting new experimental data on the circadian clock, lifestyle, and cardiometabolic risk into diagnostic tools or novel therapeutic approaches via structured multidisciplinary efforts. One of the aims of the EuRhytDia study is to study novel applications of established lifestyle interventions by co-ordinating the timing of interventions with circadian rhythmicity.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects above the age of 18
- •Night shift workers on regular night shifts with at least 3 nights in a row per month during the study period
- •Subjects must have been on night shifts for at least 4 weeks before inclusion into the study
- •Signed written informed consent
排除标准
- •Regular use of drugs (prescription or non-prescription, exception: contraceptives) or dietary supplements within 4 weeks before inclusion of the study
- •Pregnancy or breast feeding
- •Any severe somatic or psychic disease (malignant or non-malignant
- •Any known ophthalmological condition that prevents the exposure to bright light (e.g. cataract, glaucoma, retinopathy, macular degeneration, acute eye infections, lesions of the cornea)
- •Any skin condition or use of drugs associated with increased photosensitivity;
- •Any kind of disability that would prevent the subjects from participation in exercise training sessions
研究组 & 干预措施
A
Control group without intervention
B
Intensive light therapy during the first half of the night shift
干预措施: Intensive light therapy (Other)
C
Exercise before the beginning of the night shift
干预措施: Exercise (Other)
D
Exercise after the end of the night shift
干预措施: Exercise (Other)
结局指标
主要结局
Efficacy
时间窗: 12 weeks
The difference of the expression pattern of the CLOCK gene in peripheral blood mononuclear cells (PBMCs) after 12 weeks between intervention and control group
次要结局
- Efficacy(12 weeks)