Physical Activity Stress and Sleep in Adolescents

Adolescent Problem Behavior Clinical Trial

— APADOSLEEP  

Official title:

Effect of Physical Activity Program During Academic Stress on Adolescent Sleep

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04187885
• Other study ID #: University Tunis El Manar
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: March 3, 2022

Study information

• Verified date: December 2019
• Source: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
• Contact: Amani Kallel, PHD, HDR
• Phone: 0021696872787
• Email: kalamany2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• Continuous sleep assessments (duration and quality) by accelerometry

• Continuous physical activity and sedentary behaviour assessments by accelerometry

• one evaluation of melatonin peak from salivary specimens

• one evaluation of cortisol peak from salivary specimens

• An evaluation of the ad libitum food intake of the 5th day will be carried out by the weighing method.

• one assessment of cognitive performance

• An evaluation of subjective appetite sensations (hunger, fullness, desire to eat) of the 5th day

• An evaluation of subjective diurnal sleepiness (Karolinska) of the 5th day

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: March 3, 2022
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• college adolescent Tanner stages 3-5

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adolescent Problem Behavior
• Problem Behavior

Intervention

Behavioral:
• Group/Cohort 2: PAP
Each experimental session will be carried out over 5 days of a week. Adolescents will take part randomly in four sessions. Physical activity program will be identical between sessions and groups. 60 min 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose	Biochimie Clinique LR99ES11, Department of Biochemistry, La Rabta Hospital, Tunisia., Université de Toulon

References & Publications (12)

Arora, T., and Grey, I. (2019). Sleep, obesity and cardiometabolic disease in children and adolescents. In Sleep and Health, (Elsevier), pp. 421-433.

Colrain IM, Baker FC. Changes in sleep as a function of adolescent development. Neuropsychol Rev. 2011 Mar;21(1):5-21. doi: 10.1007/s11065-010-9155-5. Epub 2011 Jan 12. Review. — View Citation

Dewald JF, Meijer AM, Oort FJ, Kerkhof GA, Bögels SM. The influence of sleep quality, sleep duration and sleepiness on school performance in children and adolescents: A meta-analytic review. Sleep Med Rev. 2010 Jun;14(3):179-89. doi: 10.1016/j.smrv.2009.10.004. Epub 2010 Jan 21. — View Citation

Haugland S, Wold B, Torsheim T. Relieving the pressure? The role of physical activity in the relationship between school-related stress and adolescent health complaints. Res Q Exerc Sport. 2003 Jun;74(2):127-35. — View Citation

Ivanenko A, Crabtree VM, Gozal D. Sleep and depression in children and adolescents. Sleep Med Rev. 2005 Apr;9(2):115-29. Review. — View Citation

Kredlow MA, Capozzoli MC, Hearon BA, Calkins AW, Otto MW. The effects of physical activity on sleep: a meta-analytic review. J Behav Med. 2015 Jun;38(3):427-49. doi: 10.1007/s10865-015-9617-6. Epub 2015 Jan 18. — View Citation

Krietsch KN, Chardon ML, Beebe DW, Janicke DM. Sleep and weight-related factors in youth: A systematic review of recent studies. Sleep Med Rev. 2019 Aug;46:87-96. doi: 10.1016/j.smrv.2019.04.010. Epub 2019 Apr 23. Review. — View Citation

Lang C, Brand S, Feldmeth AK, Holsboer-Trachsler E, Pühse U, Gerber M. Increased self-reported and objectively assessed physical activity predict sleep quality among adolescents. Physiol Behav. 2013 Aug 15;120:46-53. doi: 10.1016/j.physbeh.2013.07.001. Epub 2013 Jul 9. — View Citation

Lang C, Kalak N, Brand S, Holsboer-Trachsler E, Pühse U, Gerber M. The relationship between physical activity and sleep from mid adolescence to early adulthood. A systematic review of methodological approaches and meta-analysis. Sleep Med Rev. 2016 Aug;28:32-45. doi: 10.1016/j.smrv.2015.07.004. Epub 2015 Aug 5. Review. — View Citation

Lund HG, Reider BD, Whiting AB, Prichard JR. Sleep patterns and predictors of disturbed sleep in a large population of college students. J Adolesc Health. 2010 Feb;46(2):124-32. doi: 10.1016/j.jadohealth.2009.06.016. Epub 2009 Aug 3. — View Citation

Norris R, Carroll D, Cochrane R. The effects of physical activity and exercise training on psychological stress and well-being in an adolescent population. J Psychosom Res. 1992 Jan;36(1):55-65. — View Citation

Stepanski EJ, Wyatt JK. Use of sleep hygiene in the treatment of insomnia. Sleep Med Rev. 2003 Jun;7(3):215-25. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep Efficiency (%)	the percentage of time spent asleep while in bed	change from baseline at 4th night
Secondary	bedtime	the time when the subjet goes to bed	change from baseline at 4th night
Secondary	total time in bed (minutes)	total time spent in bed	change from baseline at 4th night
Secondary	sleep onset latency (minutes)	actual time it takes to transition from wake to sleep in minutes	change from baseline at 4th night
Secondary	wake after sleep onset	awke after sleep has been initiated and before final awake	change from baseline at 4th night
Secondary	nubmer of awake >3 minutes	awkenings >3 minutes after sleep has been initiated and before final awake	change from baseline at 4th night
Secondary	Sedentary activities	time spent on Sedentary activities < 1Metabolic Equivalent of task (METs),	pre and post intervention:day 1 and day 4
Secondary	light activities	time spent on [1 - 3 ] expressed in Metabolic equivalent of task (METs)	pre and post intervention:day 1 and day 4
Secondary	moderate to vigorous activities	time spent on moderate to vigorous activities [3 - 9 Metabolic equivalent of task[	pre and post intervention : day1 and day 4
Secondary	Energy expenditure (kilo calories)	the amount of energy a person uses in the form of calories estimated by accelerometers	pre and post intervention : day1 and day 4
Secondary	circadian phase (DLMO)	evaluations of melatonin peak from salivary specimens (5 measures), time (180, 120, 60 min before bedtime, bedtime and 60 min after bedtime)	night 4
Secondary	Cortisol peak	evaluations of cortisol peak from salivary specimens (5 measures), (upon awakening, awakening + 30mn, awakening + 60mn, awakening + 120mn et awakening + 180mn)	day 5
Secondary	Stroop test	selective attention and reading ability	day 5
Secondary	Trail marking test	this test estimate visual attention and motor speed	day 5
Secondary	Barrage test	this task evaluates visual- spatial ability and recognition	day 5
Secondary	California verbal learning test.	this test evaluates primary and secondary memory	day 5
Secondary	Energy intake	Energy intake and proportion of the energy derived from each class of macronutrients (carbohydrate, fat, and protein) measured on meals offered "ad-libitum"	day 5
Secondary	Subjective appetite sensations	hunger, fullness, desire to eat and prospective food consumption : upon awakening, before and right after the breakfast, lunch, snack and dinner as well as bed time.; Appetite sensations will be collected throughout the day using visual analogue scales (150 mm scales). Adolescents will report their hunger, fullness, desire to eat and prospective food consumption at thirteen regulated times: upon awakening, before and right after the breakfast, lunch, snack and dinner as well as bed time. The questions were i) "How hungry do you feel?", ii) "How full do you feel?", iii) "Would you like to eat something?", iv) "How much do you think you can eat?" (adolescents were asked to respond on a scale from "not at all" to "a lot"). This method has been previously validated	day 5
Secondary	Subjective sleepiness (Karolinska scale)	this scale mesures the subjective level os sleepness at particular times during the day. this is a nine point scale (1= extreemly alert, 3= alert, 5= neither nor sleepy, 7 = sleepy but no difficulty for main awake, 9= extreemly sleepy/ fighting sleep).	day 5