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临床试验/NCT04187885
NCT04187885Unknown不适用

Effect of Physical Activity Program During Academic Stress on Adolescent Sleep

Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose0 个研究点目标入组 56 人开始时间: 2020年9月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
56
主要终点
sleep Efficiency (%)

研究概览

简要总结

Adolescence is characterized by major transitions in sleep and circadian rhythm. This rapid pivotal period increases the risks of sleep debt and poor sleep quality, leading to pronounced diurnal fatigue and drowsiness. On the other hand, academic stress has been also associated with increased sleep disturbances.

Both academic stress and poor sleep in adolescents has been linked to increased sleepiness rate, reduced alertness, lower academic performances and the impairment of the control of energy balance through hyperphagia.

Despite the importance of sleep in holistic development, physical (i.e. recovery, metabolism, muscle growth, weight control), cognitive (i.e. learning, memory, decision-making, Vigilance). Few studies have been designed to improve this behavior among college adolescents, especially in times of academic stress.

Physical activity has been suggested as a non-pharmacological alternative treatment for sleep disorders . Generally, it is well established that the duration and quality of sleep were improved by regular physical activity among adolescents and far better, it was suggested that the exercise-mediated effect on sleep could be even observed in the short term. Moreover, it was suggested that aerobic exercise has positive effects on psychological stress and well-being of adolescents .

Therefore, APADOSLEEP trial, was designed to examine the effect of physical activity program on sleep during and outside periods of academic stress.

详细描述

Counterbalanced, cross-over, pre-post trial where each subject acts as his own control.

Four sessions will be performed for each adolescent. Each session will be conducted over 5 days (from Monday to Friday):

Adolescents will take part randomly in four sessions. Physical activity program will be identical between sessions and groups. 60 minn of moderate to vigorous leisure activities and exercises will be proposed each day. Heart rate monitor will be used to control intensity of exercise during the physical activity program.

  • Control session (CTL) outside academic stress period (represented by exams) and without the physical activity program.
  • A session outside academic stress period, with the physical activity program (PAP).
  • A session during an academic stress period without the physical activity program (AS).
  • A session during an academic stress period with the physical activity program (ASPAP).

At each session:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • college adolescent Tanner stages 3-5

排除标准

  • Disorders and / or pathology of sleep
  • Medical or surgical history not compatible with the study, any other chronic illness or injury that may interfere with the subject's abilities
  • Take medication that may interfere with the results of the study (corticosteroids ...) or sleeping pills
  • Surgical intervention in the previous 3 months
  • Regular consumption of tobacco, cannabis or alcohol
  • Special diet

结局指标

主要结局

sleep Efficiency (%)

时间窗: change from baseline at 4th night

the percentage of time spent asleep while in bed

次要结局

  • bedtime(change from baseline at 4th night)
  • sleep onset latency (minutes)(change from baseline at 4th night)
  • wake after sleep onset(change from baseline at 4th night)
  • total time in bed (minutes)(change from baseline at 4th night)
  • nubmer of awake >3 minutes(change from baseline at 4th night)
  • moderate to vigorous activities(pre and post intervention : day1 and day 4)
  • Energy expenditure (kilo calories)(pre and post intervention : day1 and day 4)
  • Sedentary activities(pre and post intervention:day 1 and day 4)
  • light activities(pre and post intervention:day 1 and day 4)
  • circadian phase (DLMO)(night 4)
  • Cortisol peak(day 5)
  • Stroop test(day 5)
  • Trail marking test(day 5)
  • Barrage test(day 5)
  • California verbal learning test.(day 5)
  • Energy intake(day 5)
  • Subjective appetite sensations(day 5)
  • Subjective sleepiness (Karolinska scale)(day 5)

研究者

发起方
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
申办方类型
Other
责任方
Sponsor

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