Older Adults Exercising On Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Insomnia severity
研究概览
简要总结
There are indications from epidemiological cohort studies and animal experiments that timing of physical activity (also referred as "chronoactivity"), irrespective of intensity, impacts health and disease. In view of the detrimental effects of circadian misalignment, the large group of older people suffering from sleep problems, and the seeming importance of chronoactivity, the investigators will perform a randomised cross-over study that aims to uncover the effect of timing of physical activity on insomnia severity and related(circadian) health parameters in older adults with self-reported sleep problems. Here, the investigators hypothesize that timing of physical activity has a beneficial impact on insomnia symptoms and on circadian rhythms of additional health parameters (e.g., metabolic, psychosocial) in older people. To study this research hypothesis, the investigators will examine the effect of physical activity timing on insomnia severity in older adults with self-reported sleep problems. In addition, the investigators will examine the effect of physical activity timing on exploratory rhythmic parameters of biological clock function, physiology and metabolism, mental health, behavioural factors, and immune and cell signalling functions. For this study, a two-armed randomised cross-over study, Dutch speaking older adults between 60 and 80 years old (male and female) and having sleep problems (insomnia severity index>10 points) from the general population in the Netherlands will be selected as participants for this study. Participants will perform one sedentary period and two period of increased physical activity with different daily patterns: 1)active morning; 2) active evening with a duration of 14 days each. In both active intervention arms, participants will follow an exercise program containing outdoor physical exercise sessions (Vitality Club) containing endurance and strength exercises, relative rest days of 30 minutes light intensity physical activity, and one Active@Home program; a 1-hour training session of various moderate to vigorous activities. The training sessions will be held either in the morning or evening (depending on the intervention arm) and will be one hour long. Study outcomes will be compared between the different intervention groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 60 and 80 years old
- •Long lasting sleep problems (as assessed by a the screening questionnaire administered telephonically and by the ISI which will be filled out during the screening visit)
- •Access to and ability to use a smart phone (Android or Apple)
排除标准
- •Currently employed or working
- •Extreme sleep chronotypes (measured by the Munich chronotype questionnaire)
- •Participation in any sort of fasting regimen (e.g. intermitted fasting or Ramadan)
- •Experienced recent (<6 months) adverse life events (e.g., death of partner)
- •Abnormal values in glucose metabolism, thyroid, liver or kidney function, or inflammation markers that after examination of the study doctor need immediate attention of a general practitioner or specialist.
- •Diagnosed clinical depression
- •Diagnosed neurodegenerative diseases (e.g. dementia or Parkinson's disease)
- •Diagnosed sleep apnoea
- •Diagnosed restless legs syndrome
- •Use of beta-adrenergic blocking agents
- •Use of sleep medication*
- •Injuries or other severe physical conditions (such as active arthrosis) that inhibits physical activity
- •Travelled across time zones one week prior to start of study
结局指标
主要结局
Insomnia severity
时间窗: 4 times in total: at baseline T-3 (T= week), at T2 , T5, and at T8 (endline).
Score on Insomnia Severity Index (ISI). Participants will be asked to fill out the ISI questionnaire (Dutch version) The ISI questionnaire consists of 7 questions and outcomes include: 'No clinically significant insomnia (0-7 points)', 'Subthreshold insomnia (8-14 points)', 'Moderate severity clinical insomnia (15-21 point), and 'Severe clinical insomnia (22-28 points)'.
次要结局
- Dim light melatonin onset (DLMO)(3 times in total: two weeks, five weeks and eight weeks after baseline.)
- Ecological monitoring assessment(3 periods in total of one week each: the second week, the fifth week and the eighth week.)
- Sleep quality - sleep duration(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
- Sleep quality - sleep latency(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
- Sleep quality - sleep stages(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
- Sleep quality - sleep efficiency(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
- Sleep quality - sleep regularity(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
- Biological assessment: clock gene expression(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
- Biological assessment: metabolomics(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
- Biological assessment: proteomics(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
- Biological assessment: glucose metabolism(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
- Biological assessment: biomarkers for inflammation, thyroid, kidney and liver function(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
- Food capturing(3 periods in total of one week each: week two, week five, and at week eight.)
- Heart rate(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
- Heart rate variability(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
- Core body temperature(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
研究者
dvanheemst
Principal investigator
Leiden University Medical Center