Clinical trial NCT04552626: Activity Breaks for Brain Health in Adolescents
Official title: Acute Effects From Prolonged Inactivity and Physical Activity Interventions on Cortical Blood Flow and Arterials Stiffness in School-aged Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adolescents
Lead sponsor: The Swedish School of Sport and Health Sciences
Sponsor class: OTHER
Collaborators: name: The Knowledge Foundation
name: IKEA
name: Skandia
name: Konsumentföreningen Stockholm
name: Generation PEP
name: COOP
First posted: 2020-09-17
Enrollment: 17
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The main aim for this study is to investigate to what extent physical activity of moderate or low intensity, relative to prolonged inactivity, may acutely alter neural activity-related prefrontal cortex oxygenated hemoglobin during a cognitive demanding task in 13- 15 year-old adolescents. The study is primarily focused on investigating these effects in ecologically valid conditions, i.e. activity patterns that closely resemble a typical day in school and using activity modes that are suitable in a school setting.

Detailed description: The study will be a controlled crossover experimental trial with three conditions. Each participant will complete each of the three experimental conditions, separated by a washout period of minimum four days. Physical activity behaviours and sleep will be monitored the day/night before each test day. The first visit will be a familiarization session for the collection of demographic data, fitness testing, and acquaintance with experimental procedures. On the second, third, and fourth visits, participants will undergo three different standardized 80-minutes interventions in a randomized order. Before and immediately after the 80-minutes interventions, blood pressure, augmentation index, and cerebral hemodynamic response of the prefrontal cortex during standardized cognitive tasks (nback test) will be measured. Additionally, saliva samples will be collected the morning of the test day, and before and after the interventions.

Eligibility criteria: Exclusion Criteria:

* Ongoing medication that can affect central circulation or brain circulation
* Ongoing infection
* Inability to apprehend information about the study or to perform the tests

Primary outcomes:
measure: Changes in cerebral blood flow
timeFrame: before to after 80 minutes intervention
Secondary outcomes:
measure: Cognitive performance
timeFrame: before and after 80 minutes intervention
measure: Augmentation index
timeFrame: before and after 80 minutes intervention
measure: Cortisol
timeFrame: morning; before and after 80 minutes intervention
measure: Mood
timeFrame: at the beginning of the day; before and after 80 minutes intervention
measure: Sleepiness
timeFrame: at the beginning of the day; before and after 80 minutes intervention
measure: Alertness
timeFrame: at the beginning of the day; before and after 80 minutes intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: The Swedish School of Sport and Health Sciences (GIH)
Study officials:
affiliation: The Swedish School of Sport and Health Sciences
name: Örjan Ekblom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heiland EG, Kjellenberg K, Tarassova O, Fernstrom M, Nyberg G, Ekblom MM, Helgadottir B, Ekblom O. ABBaH teens: Activity Breaks for Brain Health in adolescents: study protocol for a randomized crossover trial. Trials. 2022 Jan 6;23(1):22. doi: 10.1186/s13063-021-05972-5.