PDF(Pubmed)
Abstract：
BACKGROUND: There are increased indications that physical activity timing, irrespective of intensity, impacts insomnia and circadian clock function. Here, we describe the rationale and design of a randomized cross-over study, called ON TIME, to examine the effects of (changing) physical activity timing on insomnia severity and on multiple exploratory outcomes that are linked to circadian clock function.
METHODS: We will conduct a randomized cross-over trial in 40 healthy older adults (aged 65 to 75 years) with subclinical or clinical insomnia (Insomnia Severity Index (ISI) scores of ≥ 10) from the Dutch municipality of Leiden and surroundings. Participants will undergo 3 intervention periods (14 days each) consecutively: one sedentary period and two periods of increased physical activity (one period with morning activity and one period with evening activity). The intervention periods are separated by a wash-out period of 1 week. In both active intervention arms, participants will follow coached or uncoached outdoor physical exercise sessions comprising endurance, strength, and flexibility exercises for 14 days. The primary outcome is change in insomnia severity as measured by the ISI. Additional exploratory outcomes include multiple components of objective sleep quality measured with tri-axial accelerometry and subjective sleep quality assessed by questionnaires as well as dim light melatonin onset and 24-h rhythms in heart rate, heart rate variability, breathing rate, oxygen saturation, mood, and objective emotional arousal and stress. Additionally, we will collect diary data on eating patterns (timing and composition). Finally, fasting blood samples will be collected at baseline and after each intervention period for measurements of biomarkers of metabolic and physiological functioning and expression of genes involved in regulation of the biological clock.
CONCLUSIONS: We anticipate that this study will make a significant contribution to the limited knowledge on the effect of physical activity timing. Optimizing physical activity timing has the potential to augment the health benefits of increased physical exercise in the aging population.
BACKGROUND: Trial was approved by the Medical Ethics Committee Leiden, The Hague, Delft, The Netherlands (June, 2023). The trial was registered in the CCMO-register https://www.toetsingonline.nl/to/ccmo_search.nsf/Searchform?OpenForm under study ID NL82335.058.22 and named (\"Ouderen op tijd in beweging\" or in English \"Older adults exercising on time\"). At time of manuscript submission, the trial was additionally registered at ClinicalTrials.gov under study ID: NL82335.058.22 and is awaiting approval.
METHODS: We will conduct a randomized cross-over trial in 40 healthy older adults (aged 65 to 75 years) with subclinical or clinical insomnia (Insomnia Severity Index (ISI) scores of ≥ 10) from the Dutch municipality of Leiden and surroundings. Participants will undergo 3 intervention periods (14 days each) consecutively: one sedentary period and two periods of increased physical activity (one period with morning activity and one period with evening activity). The intervention periods are separated by a wash-out period of 1 week. In both active intervention arms, participants will follow coached or uncoached outdoor physical exercise sessions comprising endurance, strength, and flexibility exercises for 14 days. The primary outcome is change in insomnia severity as measured by the ISI. Additional exploratory outcomes include multiple components of objective sleep quality measured with tri-axial accelerometry and subjective sleep quality assessed by questionnaires as well as dim light melatonin onset and 24-h rhythms in heart rate, heart rate variability, breathing rate, oxygen saturation, mood, and objective emotional arousal and stress. Additionally, we will collect diary data on eating patterns (timing and composition). Finally, fasting blood samples will be collected at baseline and after each intervention period for measurements of biomarkers of metabolic and physiological functioning and expression of genes involved in regulation of the biological clock.
CONCLUSIONS: We anticipate that this study will make a significant contribution to the limited knowledge on the effect of physical activity timing. Optimizing physical activity timing has the potential to augment the health benefits of increased physical exercise in the aging population.
BACKGROUND: Trial was approved by the Medical Ethics Committee Leiden, The Hague, Delft, The Netherlands (June, 2023). The trial was registered in the CCMO-register https://www.toetsingonline.nl/to/ccmo_search.nsf/Searchform?OpenForm under study ID NL82335.058.22 and named (\"Ouderen op tijd in beweging\" or in English \"Older adults exercising on time\"). At time of manuscript submission, the trial was additionally registered at ClinicalTrials.gov under study ID: NL82335.058.22 and is awaiting approval.
摘要：
背景：有越来越多的迹象表明身体活动时间，无论强度如何，影响失眠和生物钟功能。这里,我们描述了随机交叉研究的原理和设计，打电话给时间，检查（改变）体育锻炼时间对失眠严重程度和与昼夜节律功能相关的多种探索性结果的影响。
方法：我们将对来自荷兰莱顿市及周边地区的40名亚临床或临床失眠（失眠严重程度指数（ISI）评分≥10）的健康老年人（65至75岁）进行一项随机交叉试验。参与者将连续经历3个干预期（每个14天）：一个久坐期和两个增加的身体活动期（一个早晨活动期和一个晚上活动期）。干预期以1周的洗出期分隔开。在两个积极干预武器中，参与者将遵循有教练或无教练的户外体育锻炼课程，包括耐力，力量,和14天的灵活性练习。主要结果是通过ISI测量的失眠严重程度的变化。其他探索性结果包括使用三轴加速度测量法测量的客观睡眠质量的多个组成部分和通过问卷调查评估的主观睡眠质量，以及昏暗的褪黑激素发作和心率的24小时节律。心率变异性,呼吸频率,氧饱和度,心情,和客观的情绪唤醒和压力。此外,我们将收集有关饮食模式（时间和组成）的日记数据。最后,空腹血液样本将在基线和每个干预期后收集，用于测量代谢和生理功能的生物标志物以及与生物钟调节有关的基因的表达。
结论：我们预计这项研究将对体力活动时间影响的有限知识做出重大贡献。优化体育锻炼时间有可能增加老年人口体育锻炼的健康益处。
背景：试验由医学伦理委员会莱顿批准，海牙,代尔夫特,荷兰（6月，2023年）。该试验已在CCMO-registerhttps://www中注册。toetsingonline.nl/to/ccmo_search。nsf/Searchform?OpenFormunderstudyIDNL82335.058.22andnamed(\"Ouderenoptijdinbeweging\"orinEnglish\"Oderadultsexercisingontime\").在投稿时,该试验另外在ClinicalTrials.gov注册,研究ID:NL82335.058.22,目前正在等待批准.
方法：我们将对来自荷兰莱顿市及周边地区的40名亚临床或临床失眠（失眠严重程度指数（ISI）评分≥10）的健康老年人（65至75岁）进行一项随机交叉试验。参与者将连续经历3个干预期（每个14天）：一个久坐期和两个增加的身体活动期（一个早晨活动期和一个晚上活动期）。干预期以1周的洗出期分隔开。在两个积极干预武器中，参与者将遵循有教练或无教练的户外体育锻炼课程，包括耐力，力量,和14天的灵活性练习。主要结果是通过ISI测量的失眠严重程度的变化。其他探索性结果包括使用三轴加速度测量法测量的客观睡眠质量的多个组成部分和通过问卷调查评估的主观睡眠质量，以及昏暗的褪黑激素发作和心率的24小时节律。心率变异性,呼吸频率,氧饱和度,心情,和客观的情绪唤醒和压力。此外,我们将收集有关饮食模式（时间和组成）的日记数据。最后,空腹血液样本将在基线和每个干预期后收集，用于测量代谢和生理功能的生物标志物以及与生物钟调节有关的基因的表达。
结论：我们预计这项研究将对体力活动时间影响的有限知识做出重大贡献。优化体育锻炼时间有可能增加老年人口体育锻炼的健康益处。
背景：试验由医学伦理委员会莱顿批准，海牙,代尔夫特,荷兰（6月，2023年）。该试验已在CCMO-registerhttps://www中注册。toetsingonline.nl/to/ccmo_search。nsf/Searchform?OpenFormunderstudyIDNL82335.058.22andnamed(\"Ouderenoptijdinbeweging\"orinEnglish\"Oderadultsexercisingontime\").在投稿时,该试验另外在ClinicalTrials.gov注册,研究ID:NL82335.058.22,目前正在等待批准.
