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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04552626
Other study ID # Dnr 2020-02597
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2020
Est. completion date December 16, 2020

Study information

Verified date February 2021
Source The Swedish School of Sport and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date December 16, 2020
Est. primary completion date December 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 14 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Prolonged sitting (social breaks)
Participants are required to sit for 80 minutes doing schoolwork, with a toilet break in between. Every twenty minutes participants will have a short social break. Test day begins at 8:00 with pretest measures, followed by the intervention at about 9:00, which will end around 12:00, with subsequent posttest measures.
Prolonged sitting with step-up exercise break
Participants are required to sit for 80 minutes doing schoolwork, with a toilet break in between. Every twenty minutes participants will have a physical activity break, where they will perform a simple moderate-intensity step-up exercise for three minutes at a predetermined pace. Test day begins at 8:00 with pretest measures, followed by the intervention at about 9:30, which will end around 12:00, with subsequent posttest measures.
Prolonged sitting with simple resistance activity breaks
Participants are required to sit for 80 minutes doing schoolwork, with a toilet break in between. Every twenty minutes participants will have a physical activity break, where they will perform simple resistance activities following a video for about three minutes. Test day begins at 8:00 with pretest measures, followed by the intervention at about 9:30, which will end around 12:00, with subsequent posttest measures.

Locations

Country Name City State
Sweden The Swedish School of Sport and Health Sciences (GIH) Stockholm

Sponsors (7)

Lead Sponsor Collaborator
The Swedish School of Sport and Health Sciences COOP, Generation PEP, IKEA, Konsumentföreningen Stockholm, Skandia, The Knowledge Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in cerebral blood flow Oxygenated and deoxygenated hemoglobin concentration changes measured with functional near-infrared spectroscopy before to after 80 minutes intervention
Secondary Cognitive performance nback cognitive test (time and accuracy) before and after 80 minutes intervention
Secondary Augmentation index measure of arterial stiffness before and after 80 minutes intervention
Secondary Cortisol measured from saliva morning; before and after 80 minutes intervention
Secondary Mood Positive and Negative Affect Schedule (PANAS) comprised of 20 affect states (10 positive and 10 negative), each affect state scored on a scale going from 1 (very slightly or not at all) to 5 (extremely) at the beginning of the day; before and after 80 minutes intervention
Secondary Sleepiness Karolinska Sleepiness Questionnaire; goes from 1 (extremely alert) to 9 (extremely sleepy) at the beginning of the day; before and after 80 minutes intervention
Secondary Alertness 100mm Visual Analogue Scale (VAS); range: 'not at all' to 'completely alert' at the beginning of the day; before and after 80 minutes intervention
See also
  Status Clinical Trial Phase
Completed NCT06047743 - Comparison of Upper and Lower Extremity Isometrics on Cognition in Healthy Adolescents N/A
Completed NCT03213613 - Double-Blind Randomized Controlled Trial for the Evaluation of a Novel Adaptive Attention Training in Healthy Adolescents N/A