- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552626
Activity Breaks for Brain Health in Adolescents (ABBaH teens)
February 23, 2021 updated by: The Swedish School of Sport and Health Sciences
Acute Effects From Prolonged Inactivity and Physical Activity Interventions on Cortical Blood Flow and Arterials Stiffness in School-aged Adolescents.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Stockholm, Sweden, 114 86
- The Swedish School of Sport and Health Sciences (GIH)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Experimental: Prolonged sitting with step-up exercise break
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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.
|
Experimental: Prolonged sitting with simple resistance activity breaks
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cerebral blood flow
Time Frame: before to after 80 minutes intervention
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Oxygenated and deoxygenated hemoglobin concentration changes measured with functional near-infrared spectroscopy
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before to after 80 minutes intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive performance
Time Frame: before and after 80 minutes intervention
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nback cognitive test (time and accuracy)
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before and after 80 minutes intervention
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Augmentation index
Time Frame: before and after 80 minutes intervention
|
measure of arterial stiffness
|
before and after 80 minutes intervention
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Cortisol
Time Frame: morning; before and after 80 minutes intervention
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measured from saliva
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morning; before and after 80 minutes intervention
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Mood
Time Frame: at the beginning of the day; before and after 80 minutes intervention
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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)
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at the beginning of the day; before and after 80 minutes intervention
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Sleepiness
Time Frame: at the beginning of the day; before and after 80 minutes intervention
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Karolinska Sleepiness Questionnaire; goes from 1 (extremely alert) to 9 (extremely sleepy)
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at the beginning of the day; before and after 80 minutes intervention
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Alertness
Time Frame: at the beginning of the day; before and after 80 minutes intervention
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100mm Visual Analogue Scale (VAS); range: 'not at all' to 'completely alert'
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at the beginning of the day; before and after 80 minutes intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Örjan Ekblom, PhD, The Swedish School of Sport and Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2020
Primary Completion (Actual)
December 16, 2020
Study Completion (Actual)
December 16, 2020
Study Registration Dates
First Submitted
September 10, 2020
First Submitted That Met QC Criteria
September 10, 2020
First Posted (Actual)
September 17, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Dnr 2020-02597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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