NCT06319833

Brief Summary

A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

February 2, 2024

Last Update Submit

March 12, 2024

Conditions

Keywords

active breaksexecutive functionsacademic performanceexercise

Outcome Measures

Primary Outcomes (6)

  • Academic achievement

    Only the general academic fluency index was administered, consisting of the reading, mathematics, and writing fluency subtests. Reading fluency assessed the participant's capacity to read simple sentences rapidly, mathematical fluency gauged the ability to quickly solve simple addition, subtraction, and multiplication problems, and writing fluency measured the skill to formulate and write sentences promptly.

    8 weeks

  • Inhibition-attention and cognitive flexibility

    The assessment of inhibition-attention and cognitive flexibility was conducted using the "Trail Making Test".

    8 weeks

  • Working memory

    The measurement of working memory through "The Digit Memory Test," specifically focusing on auditory attention and verbal memory.

    8 weeks

  • Selective attention

    The measurement of selective attention within a limited timeframe was carried out using the "D2 test."

    8 weeks

  • Design of active breaks: semi-structured questionnaires

    Pre- and post-intervention, to guarantee a proper design and future sustainability of the experimental condition, semi-structured questionnaires are administered to students. The responses are systematically categorized.

    2 months (november and may)

  • Design of active breaks: semi-structured interviews

    Pre- and post-intervention, to guarantee a proper design and future sustainability of the experimental condition, semi-structured interviews are administered to teachers and the management team. The responses are systematically categorized.

    2 months (november and may)

Secondary Outcomes (8)

  • Physical activity patterns

    8 weeks

  • Self-report physical activity patterns

    8 weeks

  • Self-report sedentary patterns

    8 weeks

  • Self-report physical fitness

    8 weeks

  • Socioeconomic level

    8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Physical activity interacting with a video

EXPERIMENTAL

This experimental condition involves engaging in physical activity interspersed with rest periods. The type of exercises are based on phase I.

Behavioral: Physical activity interacting with a video

Control condition

NO INTERVENTION

Interventions

This experimental condition will be implemented five times a week, once per day, over 8 weeks. It will follow a structured format, including seven consecutive 40-second blocks of physical activity. The total video duration will amount to 9 minutes (40 seconds of activity followed by 20 seconds of rest, maintaining a 2:1 work-to-rest ratio). Additionally, participants will engage in 5 minutes of warm-up exercises and 5 minutes of cool-down activities. The experimental condition will consist of 10 videos, each centered around one of five different themes (a different one will be administered every day).

Physical activity interacting with a video

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 10-12 years.

You may not qualify if:

  • Children who have serious physical or mental disorders (autism spectrum disorder, intellectual disability, and cerebral palsy) that would impede participation in the experimental conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Balearic Islands

Palma, Balearic Islands, 07122, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

February 2, 2024

First Posted

March 20, 2024

Study Start

January 8, 2024

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations