NCT04575441

Brief Summary

The aim of this study is to investigate the effects of exercises conducted with pilates ball on balance, reaction time, quality of life, and behavior among preschool children. 60 volunteers, aged 4 and 5 years old, who continue kindergartens will randomly be grouped into two as study group (SG) (n=30) and control group (CG) (n=30). Exercises including pilates ball will be applied to SG children for 40 minutes, twice a week, 6 weeks. CG will continue normal daily routines for 6 weeks. Sociodemographic information of all people will be recorded after their parents signed informed consent form. Single Leg Standing (eyes open and close) for static balance, Functional Reach Test (FRT)for dynamic balance, Ruler Drop Test for reaction time, dual task performance methods will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2020

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

May 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

September 27, 2020

Last Update Submit

December 1, 2020

Conditions

Keywords

preschool childrenphysical fitnessexercisephysical activity

Outcome Measures

Primary Outcomes (1)

  • Dynamic balance

    Functional reach test is used. Children are asked to stand next to the wall with their right side and extend their right arm with 90 degree shoulder flexion. Then they are asked to extend with their arm as far as possible by protecting their lower limb posture. The distance is recorded in cm.

    change from baseline at 6 weeks

Secondary Outcomes (3)

  • Static balance

    change from baseline at 6 weeks

  • Reaction time

    change from baseline at 6 weeks

  • Dual task performance

    change from baseline at 6 weeks

Study Arms (2)

Pilates Ball Exercises

EXPERIMENTAL

Various exercises are conducted with using pilates ball. Sensory feedbacks like proprioception and vestibulation are given. Many physical fitness parameters like balance, coordination, speed and agility are used in this exercise program. Children are taken to the program for 40 min, twice a week during 6 weeks.

Other: Exercise with pilates ball

Without exercise

NO INTERVENTION

The children in this group are not included in any kind of exercise/sport program during 6 weeks.

Interventions

Pilates ball exercises are used to give various sensory stimulation and increase motor skills. Children usually enjoy these kind of exercises as there is ball in every movement.

Pilates Ball Exercises

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • having a birth year 2015 or 2016.

You may not qualify if:

  • Having cognitive, physical and/or orthopedic problem
  • Any pain which may prevent doing exercise
  • Having visual and/or auditory loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zehra Güçhan Topcu

Famagusta, 99628, Cyprus

Location

Related Publications (1)

  • Obuz T, Topcu ZG. The effects of exercises with a Pilates ball on balance, reaction time and dual-task performance of kindergarten children. J Comp Eff Res. 2022 Jun;11(8):583-593. doi: 10.2217/cer-2021-0293. Epub 2022 May 6.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Zehra Güçhan Topcu, Dr.

    Eastern Mediterranean University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 5, 2020

Study Start

May 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 10, 2020

Last Updated

December 3, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations