NCT07689474

Brief Summary

This randomized controlled study evaluated whether an 8-week balance-cognitive-strength training program improved balance ability, inhibitory control, and gait performance in preschool children aged 3 to 6 years. Children completed balance tests, single-task walking tests, dual-task walking tests, and an iPad-based Go/No-Go task before and after the intervention. The intervention group received exercise-cognitive integrated training 3 times per week for 8 weeks, and the control group maintained usual daily activities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 1, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

preschool childrenbalance abilitygait performancedual taskinhibitory controlexercise-cognitive interventionbalance-cognitive-strength training

Outcome Measures

Primary Outcomes (4)

  • Change From Baseline in Single-Task Gait Index at Week 8

    The Single-Task Gait Index was derived from gait variables measured during normal walking. Gait was assessed using a gait analysis system during single-task walking. Variables included stance time, stride time, double-support time, step width variability, loading rate, and related temporal-spatial gait parameters. Variables were standardized and direction-unified before construction of the gait index. Higher scores indicate better single-task gait performance. The change score was calculated as the post-intervention score minus the baseline score.

    Baseline and immediately after the 8-week intervention

  • Change From Baseline in Dual-Task Gait Index at Week 8

    The Dual-Task Gait Index was derived from gait variables measured while children walked and performed a concurrent cognitive task. During dual-task walking, participants walked while counting backward from 10 to 1. Variables included stance time, stride time, double-support time, step width variability, loading rate, and related temporal-spatial gait parameters. Variables were standardized and direction-unified before construction of the gait index. Higher scores indicate better gait performance under cognitive load. The change score was calculated as the post-intervention score minus the baseline score.

    Baseline and immediately after the 8-week intervention

  • Change From Baseline in Balance Composite Score at Week 8

    Balance ability was assessed using static and dynamic balance tasks on a Zebris force platform. The Balance Composite Score was constructed from standardized balance variables using principal component analysis. The composite score reflected anterior-posterior sway control, load symmetry, and dynamic postural adjustment. Negative indicators, such as center-of-pressure velocity and ellipse area, were direction-unified before score calculation. Higher scores indicate better overall balance ability. The change score was calculated as the post-intervention score minus the baseline score.

    Baseline and immediately after the 8-week intervention

  • Change From Baseline in Inhibitory Control Composite Score at Week 8

    Inhibitory control was assessed using an iPad-based Go/No-Go task from the Early Years Toolbox. Children were instructed to respond to Go stimuli and inhibit responses to No-Go stimuli. Accuracy and reaction time were standardized and direction-unified to create an inhibitory control composite score. Higher scores indicate better inhibitory control. The change score was calculated as the post-intervention score minus the baseline score.

    Baseline and immediately after the 8-week intervention

Secondary Outcomes (10)

  • Change From Baseline in MABC-2 Total Test Standard Score at Week 8

    Baseline and immediately after the 8-week intervention

  • Change From Baseline in MABC-2 Manual Dexterity Component Score at Week 8

    Baseline and immediately after the 8-week intervention

  • Change From Baseline in MABC-2 Aiming and Catching Component Score at Week 8

    Baseline and immediately after the 8-week intervention

  • Change From Baseline in MABC-2 Balance Component Score at Week 8

    Baseline and immediately after the 8-week intervention

  • Change From Baseline in 10-Meter Shuttle Run Time at Week 8

    Baseline and immediately after the 8-week intervention

  • +5 more secondary outcomes

Study Arms (2)

Balance-Cognitive-Strength Training

EXPERIMENTAL

Participants received an 8-week exercise-cognitive integrated training program, 3 sessions per week and 40 minutes per session. The program combined balance exercises, lower-limb strength activities, brisk walking or aerobic walking games, and embedded cognitive tasks involving counting, verbal naming, working memory, and response inhibition.

Behavioral: Balance-Cognitive-Strength Training

Usual Daily Activities

NO INTERVENTION

Participants maintained their usual kindergarten and daily physical activities during the same 8-week period and did not receive the structured balance-cognitive-strength training program.

Interventions

The intervention was an 8-week exercise-cognitive integrated training program for preschool children. Sessions were conducted 3 times per week, 40 minutes per session, at moderate intensity. The program combined balance exercises, lower-limb strength activities, brisk walking or aerobic walking games, and embedded cognitive tasks involving counting, verbal naming, working memory, and response inhibition.

Also known as: Exercise-Cognitive Integrated Training
Balance-Cognitive-Strength Training

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 3 to 6 years.
  • Children enrolled in the participating kindergarten in Weifang, China.
  • Children able to understand and follow simple instructions for motor, gait, balance, and cognitive testing.
  • Children able to participate in regular physical activity and complete the 8-week intervention or usual activity period.
  • Written informed consent provided by a parent or legal guardian.

You may not qualify if:

  • Diagnosed neurological, developmental, or motor disorder.
  • Serious cardiovascular, respiratory, musculoskeletal, or other medical condition that would limit safe participation in physical activity.
  • Lower-limb injury, deformity, or disease affecting standing, walking, balance, or jumping.
  • Visual or hearing impairment that would prevent completion of the study tasks.
  • Inability to complete the baseline assessments or comply with study procedures.
  • Participation in another structured motor or cognitive intervention during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Institute of Sport Science

Beijing, 100061, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was used because participants and trainers were aware of group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two parallel groups: an 8-week balance-cognitive-strength training group or a usual daily activity control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

October 1, 2024

Primary Completion

February 25, 2025

Study Completion

February 25, 2025

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study involved preschool children and the informed consent and ethics approval did not include public sharing of individual-level participant data. Summary results will be reported in publications and on ClinicalTrials.gov as required.

Locations