NCT05744323

Brief Summary

The goal of this clinical trial is to examine the effects that functional training may have on the development of fundamental motor skills and to create a systematic functional training program suitable for healthy children aged 6-7 years. The main question\[s\] it aims to answer are:

  • \[To examine the effects of functional training on FMS among children aged 6-7 years.\]
  • \[To compare the effects of functional training on FMS between boys and girls\] This study will include an experimental group and a control group. The experimental group will engage in functional training, while the control group will follow the state-mandated physical education curriculum. Through experiments, we will investigate the effect of functional training on children's fundamental motor skills and assess whether the experimental group's intervention effect is superior to the control group. The samples in this study were normal Chinese children aged 6-7 years. There were 40 people in both the experimental and control groups, including 20 boys and 20 girls

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

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

February 9, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

February 9, 2023

Last Update Submit

November 30, 2023

Conditions

Keywords

functional training

Outcome Measures

Primary Outcomes (3)

  • Use the TGMD-2 scale to test locomotor skills

    6 patterns tested within locomotor subtests. The scoring is based on points listed for each pattern. The total score is 24 points. The athletic performance will be criterion-based scores compared with norm-referenced standards.

    baseline, pre-intervention/Change from baseline locomotor skills at 12 weeks.

  • Use the TGMD-2 scale to test object control skills

    6 patterns tested within object control subtests. The scoring is based on points listed for each pattern. The total score is 24 points. The athletic performance will be criterion-based scores compared with norm-referenced standards.

    baseline, pre-intervention/Change from baseline object control skills at 12 weeks.

  • Use the Y-test to test balance skill

    YBT requires children to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial. The YBT composite score is calculated by summing the 3 reach directions and normalizing the results to the lower limb length. All measurement scores were taken from scales on standing boards to the nearest 0.5 cm. Distances can be read from the test equipment. Each test was repeated three times, and the maximum range in each direction was recorded.

    baseline, pre-intervention/Change from baseline object balance skills at 12 weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will engage in functional training

Other: Functional training

Control group

NO INTERVENTION

the control group will follow the state-mandated physical education curriculum.

Interventions

Physical and motor function training for children,may use BOSU balls, medicine balls, balance mats, fitness steps, and other training equipment to improve gradually

Experimental group

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Chinese Children in Taiyuan
  • Primary school children are aged 6-7
  • Including both gender boys and girls

You may not qualify if:

  • Children cannot normally participate in regular physical education courses.
  • The children have movement disorders.
  • The children have physical or mental diseases.
  • During the training period, the children have to do other sports training.
  • The procedure for selecting samples will make use of stratified sampling in addition to a random number table.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuyi Road Primary School, Taiyuan City, Shanxi Province, China

Taiyuan, Shanxi, 030012, China

Location

Related Publications (7)

  • Baron J, Bieniec A, Swinarew AS, Gabrys T, Stanula A. Effect of 12-Week Functional Training Intervention on the Speed of Young Footballers. Int J Environ Res Public Health. 2019 Dec 24;17(1):160. doi: 10.3390/ijerph17010160.

    PMID: 31878326BACKGROUND
  • James, C. R. (2007). Functional Training for Athletes At All Levels.

    BACKGROUND
  • Boyle, M. (2004). Functional training for sports. Human Kinetics Publishers.

    BACKGROUND
  • Liebenson, C. (2014). Functional training handbook. Lippincott Williams & Wilkins.

    BACKGROUND
  • Heggond, M. S., Suresh, M. M., & Sundar, K. (2020). Impact of functional training on selected motor fitness components of sprinters. Journal of Xi'an University of Architecture & Technology, 12, 649-654.

    RESULT
  • Kovac D, Krkeljas Z, Venter R. Effect of six-week traditional resistance and functional training on functional performance in female netball players. BMC Sports Sci Med Rehabil. 2022 Jan 15;14(1):10. doi: 10.1186/s13102-022-00402-8.

  • Radcliffe, J. C. (2007). Functional training for athletes at all levels: workouts for agility, speed and power. Simon and Schuster.

    RESULT

Study Officials

  • Kim Geok soh

    Universiti Putra Malaysia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
in order to avoid the Contamination caused by the mutual interference between the experimental group and the control group, blinding was necessary in the study. In this study, a single-blind experiment will be used to blind the participating children. During sample selection and grouping, the participating children will not know the specific grouping situation, and will not be informed of the relevant experimental objectives
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The study will be conducted using a randomized controlled trial (RCT), and the study will be divided into three parts: pre-study baseline testing, intervention training and post-study testing. The entire experiment will be conducted in the first academic year of 2023.2-2023.4. A pilot study will be carried out first, followed by the actual research, in order to provide the framework and offer support for the full-scale experiment that will follow. The subjects involved in this study are 6-year-old and 7-year-old children, all students participating in the study will be divided into experimental and control groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 27, 2023

Study Start

March 1, 2023

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations