Attention Capacity and Before-school Physical Activity Intervention Program

NCT03893149 | Completed DMC

• 1 other identifier: N°: 938 USACH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the evidence and the potential of physical activity related to cognition and academic performance in children, the effects of a before-school physical activity program on these parameters remains unknown.

Conditions

Physical Activity; Behavior; Child Behavior; Attention Deficit Hyperactivity Disorder

Keywords

Exercise; Prevention; Attention capacity

Outcome Measures

Primary Outcomes (1)

• Selective attention

  The D2- Test were used as indicators of selective attention

  Change from Baseline and 8-weeks immediately after the interventions ends

Secondary Outcomes (12)

• Academic performance

  Change from Baseline and 8-weeks immediately after the interventions ends

• Executive function

  Change from Baseline and 8-weeks immediately after the interventions ends

• Body fat percentage

  Change from Baseline and 8-weeks immediately after the interventions ends

• Body mass index

  Change from Baseline and 8-weeks immediately after the interventions ends

• Waist circumference

  Change from Baseline and 8-weeks immediately after the interventions ends

Study Arms (2)

Active-Start intervention

EXPERIMENTAL

Supervised exercise training

Behavioral: Active-Start intervention; Behavioral: No Intervention

Control group

NO INTERVENTION

No-exercise

Interventions

Active-Start intervention BEHAVIORAL

Supervised exercise training. The intervention is a physical activity intervention that consist of 5 times per week before starting the first school-class (8:00-8:30 a.m.), 5 times per week. Each session was previously planned and described in a manual dedicated to the study. These sessions were designed by the research team and delivered by a graduate in Sport The intervention program included sports games adapted to the age of the participants, playground games, dance and other recreational activities. The intensity of the main part of the sessions was moderate-to-vigorous according to a previous study and this intensity was confirmed by accelerometry. Also, different activities favoring social interactions were designed to facilitate the interactions between the participants at the end of the sessions (cold-down).

Active-Start intervention

No Intervention BEHAVIORAL

No-exercise

Active-Start intervention

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All students in fourth grade (aged 8-10 years)
• Children's parents/caregivers will give their written consent to the children's participation.
• Collaboration in the family to respond to questionnaires

You may not qualify if:

• Children with some physical pathology or medical contraindication to perform physical exercise
• Diagnosed with learning disabilities or mental disorders

Sponsors & Collaborators

• Universidad Santo Tomas: lead
• Universidad Pública de Navarra: collaborator

Study Sites (1)

Universidad de Santiago de Chile

Santiago, Chile

Location

MeSH Terms

Conditions

Motor Activity; Behavior; Child Behavior; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio García-Hermoso, PhD

  Universidad de Santiago de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 28, 2019
• Study Start: March 3, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 5, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD

Locations

CL (1)