NCT04552626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 17, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

September 10, 2020

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in cerebral blood flow

    Oxygenated and deoxygenated hemoglobin concentration changes measured with functional near-infrared spectroscopy

    before to after 80 minutes intervention

Secondary Outcomes (6)

  • Cognitive performance

    before and after 80 minutes intervention

  • Augmentation index

    before and after 80 minutes intervention

  • Cortisol

    morning; before and after 80 minutes intervention

  • Mood

    at the beginning of the day; before and after 80 minutes intervention

  • Sleepiness

    at the beginning of the day; before and after 80 minutes intervention

  • +1 more secondary outcomes

Study Arms (3)

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

Interventions

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 (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 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 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 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.

Prolonged sitting with simple resistance activity breaks

Eligibility Criteria

Age13 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Swedish School of Sport and Health Sciences (GIH)

Stockholm, 114 86, Sweden

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Örjan Ekblom, PhD

    The Swedish School of Sport and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 17, 2020

Study Start

September 17, 2020

Primary Completion

December 16, 2020

Study Completion

December 16, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations