Healthy AdolescentsABBaH teensNCT04552626
Activity Breaks for Brain Health in Adolescents
A study testing Prolonged sitting (social breaks), Prolonged sitting with step-up exercise break and Prolonged sitting with simple resistance activity breaks in people with Healthy Adolescents, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 13 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adolescents
- What is being tested?
- Prolonged sitting (social breaks), Prolonged sitting with step-up exercise break and Prolonged sitting with simple resistance activity breaks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- 17 Sep 2020to 16 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Ongoing medication that can affect central circulation or brain circulation
- Ongoing infection
- Inability to apprehend information about the study or to perform the tests
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Swedish School of Sport and Health Sciences (GIH)
Stockholm, 114 86
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Adolescents
- Being tested
- Prolonged sitting (social breaks), Prolonged sitting with step-up exercise break, Prolonged sitting with simple resistance activity breaks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged sitting (social breaks)Behavioural
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 breakBehavioural
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 breaksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting (social breaks) | Experimental | Not described Receives: Behavioral: Prolonged sitting (social breaks) |
| Prolonged sitting with step-up exercise break | Experimental | Not described Receives: Behavioral: Prolonged sitting with step-up exercise break |
| Prolonged sitting with simple resistance activity breaks | Experimental | Not described Receives: Behavioral: Prolonged sitting with simple resistance activity breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral blood flow
Oxygenated and deoxygenated hemoglobin concentration changes measured with functional near-infrared spectroscopy
Measured: before to after 80 minutes intervention
Secondary outcomes (6)
Cognitive performance
nback cognitive test (time and accuracy)
Measured: before and after 80 minutes intervention
Augmentation index
measure of arterial stiffness
Measured: before and after 80 minutes intervention
Cortisol
measured from saliva
Measured: morning; before and after 80 minutes intervention
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)
Measured: at the beginning of the day; before and after 80 minutes intervention
Sleepiness
Karolinska Sleepiness Questionnaire; goes from 1 (extremely alert) to 9 (extremely sleepy)
Measured: at the beginning of the day; before and after 80 minutes intervention
Alertness
100mm Visual Analogue Scale (VAS); range: 'not at all' to 'completely alert'
Measured: at the beginning of the day; before and after 80 minutes intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start17 Sep 2020
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Swedish School of Sport and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Knowledge Foundation, IKEA, Skandia, Konsumentföreningen Stockholm, Generation PEP, COOP
- Responsible party
- Sponsor
- Investigators
- Örjan Ekblom, PhD, Principal investigator, The Swedish School of Sport and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552626
- Sponsor's protocol ID
- Dnr 2020-02597
- Acronym
- ABBaH teens
- Status last verified
- Feb 2021
- First submitted
- 10 Sep 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kjellenberg K, Ekblom O, Tarassova O, Fernstrom M, Nyberg G, Ekblom MM, Helgadottir B, Heiland EG. Short, frequent physical activity breaks improve working memory while preserving cerebral blood flow in adolescents during prolonged sitting - AbbaH teen, a randomized crossover trial. BMC Public Health. 2024 Aug 2;24(1):2090. doi: 10.1186/s12889-024-19306-y.
PubMed 39095724Heiland 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.
PubMed 34991692
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects From Prolonged Inactivity and Physical Activity Interventions on Cortical Blood Flow and Arterials Stiffness in School-aged Adolescents.
- ClinicalTrials.gov ID
- NCT04552626
- Acronym / sponsor ID
- ABBaH teens / Dnr 2020-02597
- Conditions
- Healthy Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Swedish School of Sport and Health SciencesUniversity, hospital or other
- Collaborators
- The Knowledge Foundation, IKEA, Skandia, Konsumentföreningen Stockholm, Generation PEP, COOP
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting (social breaks) | Experimental | Behavioral: Prolonged sitting (social breaks) |
| Prolonged sitting with step-up exercise break | Experimental | Behavioral: Prolonged sitting with step-up exercise break |
| Prolonged sitting with simple resistance activity breaks | Experimental | Behavioral: Prolonged sitting with simple resistance activity breaks |
Who may qualify
- Ages
- 13 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Ongoing medication that can affect central circulation or brain circulation
- Ongoing infection
- Inability to apprehend information about the study or to perform the tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Prolonged sitting (social breaks) |
| Prolonged sitting with step-up exercise breakParticipants 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. | Behavioural | Prolonged sitting with step-up exercise break |
| Prolonged sitting with simple resistance activity breaksParticipants 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. | Behavioural | Prolonged sitting with simple resistance activity breaks |
Primary outcome
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
6 secondary outcomes
Cognitive performance
Time frame: before and after 80 minutes intervention
Augmentation index
Time frame: before and after 80 minutes intervention
Cortisol
Time frame: morning; before and after 80 minutes intervention
Mood
Time frame: 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
Alertness
Time frame: at the beginning of the day; before and after 80 minutes intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 39095724Kjellenberg K, Ekblom O, Tarassova O, Fernstrom M, Nyberg G, Ekblom MM, Helgadottir B, Heiland EG. Short, frequent physical activity breaks improve working memory while preserving cerebral blood flow in adolescents during prolonged sitting - AbbaH teen, a randomized crossover trial. BMC Public Health. 2024 Aug 2;24(1):2090. doi: 10.1186/s12889-024-19306-y.
- Derived from this study: PubMed 34991692Heiland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Örjan Ekblom, PhD principal investigator
The Swedish School of Sport and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged sitting (social breaks), Prolonged sitting with step-up exercise break and Prolonged sitting with simple resistance activity breaks in people with Healthy Adolescents, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cerebral blood flow (time frame: before to after 80 minutes intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04552626, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.