NCT02000492

Brief Summary

Inactivity among schoolchildren is a challenge to public health and for the municipality in particular. This study´s aim is to evaluate the cognitive and physical as well as social and fitness adaptations, and learning outcomes of short- and long term ball training for 9-11 years old girls and boys, and to determine to what extend the organisation (5x12 minutes og 3x40 minute a week) and type of training (ball games, circuit training or running) influence the magnitude of response.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
423

participants targeted

Target at P75+ 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

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

November 26, 2013

Last Update Submit

October 25, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cardiac function

    echocardiography

    1 year

  • Body composition

    dual energy x-ray absorptiometry (DXA-scanning)

    1 year

Secondary Outcomes (1)

  • Cognitive effect

    1 year

Other Outcomes (1)

  • Social effects

    1 Year

Study Arms (2)

Training

EXPERIMENTAL

Football, circuit training or running 5x12 minutes or 3x 40 minutes

Behavioral: FootballBehavioral: RunningBehavioral: Circuit training

Control

NO INTERVENTION

Interventions

FootballBEHAVIORAL
Training
RunningBEHAVIORAL
Training
Training

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old girls and boys in 3rd grade in schools in Frederikssund and Copenhagen

You may not qualify if:

  • Children with severe mental or physical disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Municipality of Frederikssund

Frederikssund, Denmark, 3600, Denmark

Location

Related Publications (2)

  • Larsen MN, Madsen M, Nielsen CM, Manniche V, Hansen L, Bangsbo J, Krustrup P, Hansen PR. Cardiovascular adaptations after 10 months of daily 12-min bouts of intense school-based physical training for 8-10-year-old children. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):813-817. doi: 10.1016/j.pcad.2020.05.011. Epub 2020 Jun 1.

  • Larsen MN, Nielsen CM, Helge EW, Madsen M, Manniche V, Hansen L, Hansen PR, Bangsbo J, Krustrup P. Positive effects on bone mineralisation and muscular fitness after 10 months of intense school-based physical training for children aged 8-10 years: the FIT FIRST randomised controlled trial. Br J Sports Med. 2018 Feb;52(4):254-260. doi: 10.1136/bjsports-2016-096219. Epub 2016 Jun 13.

MeSH Terms

Interventions

RunningCircuit-Based Exercise

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor ActivityPhysical Conditioning, Human

Study Officials

  • Peter Krustrup, Professor

    Centre of team sports and health, University of Copenhagen

    PRINCIPAL INVESTIGATOR
  • Peter R Hansen, dr Msc

    University hospital og Gentofte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Municipal doktor

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 4, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations