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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Sweden
      • Stockholm, Sweden, 114 86
        • The Swedish School of Sport and Health Sciences (GIH)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prolonged sitting (social breaks)
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.
Experimental: Prolonged sitting with step-up exercise break
Behavioral: 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.
Experimental: Prolonged sitting with simple resistance activity breaks
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in cerebral blood flow
Time Frame: before to after 80 minutes intervention
Oxygenated and deoxygenated hemoglobin concentration changes measured with functional near-infrared spectroscopy
before to after 80 minutes intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive performance
Time Frame: before and after 80 minutes intervention
nback cognitive test (time and accuracy)
before and after 80 minutes intervention
Augmentation index
Time Frame: before and after 80 minutes intervention
measure of arterial stiffness
before and after 80 minutes intervention
Cortisol
Time Frame: morning; before and after 80 minutes intervention
measured from saliva
morning; before and after 80 minutes intervention
Mood
Time Frame: at the beginning of the day; before and after 80 minutes intervention
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
Sleepiness
Time Frame: at the beginning of the day; before and after 80 minutes intervention
Karolinska Sleepiness Questionnaire; goes from 1 (extremely alert) to 9 (extremely sleepy)
at the beginning of the day; before and after 80 minutes intervention
Alertness
Time Frame: at the beginning of the day; before and after 80 minutes intervention
100mm Visual Analogue Scale (VAS); range: 'not at all' to 'completely alert'
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Swedish School of Sport and Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Knowledge Foundation
IKEA
Skandia
Konsumentföreningen Stockholm
Generation PEP
COOP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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