HealthyNCT04575441
The Effects of Exercises With Pilates Ball on Balance, Reaction Time and Dual-task Performance of Kindergarten Children
A study testing Exercise with pilates ball in people with Healthy, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise with pilates ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCyprus
- Study dates
- 1 May 2020to 10 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- having a birth year 2015 or 2016.
Who cannot join
- Having cognitive, physical and/or orthopedic problem
- Any pain which may prevent doing exercise
- Having visual and/or auditory loss
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Exercises are generally suggested starting from primary school children. However, exercise habit should be given to people from earlier ages. Moreover, doing exercise can be beneficial to improve motor skills of this age and this improvement can support other developmental areas of these children. Thus, this study aims to investigate the effects of an exercise routine on balance, reaction time and dual task performance of preschool children. This exercise program includes pilates ball to make more fun for this age group. All movements are conducted with the same pilates ball. Exercises are conducted with individual sessions in the kindergartens of children.
- Conditions
- Healthy
- Being tested
- Exercise with pilates ball
- Keywords
- preschool children, physical fitness, exercise, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with pilates ballOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 6 weeks
Secondary outcomes (3)
Static balance
Children are asked to stand on dominant leg. Their standing duration is recorded.
Measured: change from baseline at 6 weeks
Reaction time
Ruler drop test is used to measure reaction time. A rule of 50 cm long is used. Children are asked to catch the ruler as fast as possible. Since the ruler is left with its zero point below, distance is recorded in cm as the result of this outcome.
Measured: change from baseline at 6 weeks
Dual task performance
Timed-up and go (TUG) test is used as a motor skill and a cognitive task is asked from children as a second task. For timed up and go test, a three meter pathway will be marked with red colored masking tape. The TUG test is administered using 2 standard chairs and children are asked to walk in a self preferred speed. At the same time, children are asked to count many animal names.
Measured: change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 May 2020
- Primary completion1 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Güçhan, Eastern Mediterranean University
- Investigators
- Zehra Güçhan Topcu, Dr., Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575441
- Sponsor's protocol ID
- 2019/0211
- Status last verified
- Dec 2020
- First submitted
- 27 Sep 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35514277
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercises With Pilates Ball on Balance, Reaction Time and Dual-task Performance of Kindergarten Children
- ClinicalTrials.gov ID
- NCT04575441
- Acronym / sponsor ID
- 2019/0211
- Conditions
- Healthy
- Keywords
- preschool children, physical fitness, exercise, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Exercises are generally suggested starting from primary school children. However, exercise habit should be given to people from earlier ages. Moreover, doing exercise can be beneficial to improve motor skills of this age and this improvement can support other developmental areas of these children. Thus, this study aims to investigate the effects of an exercise routine on balance, reaction time and dual task performance of preschool children. This exercise program includes pilates ball to make more fun for this age group. All movements are conducted with the same pilates ball. Exercises are conducted with individual sessions in the kindergartens of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Ball Exercises | Experimental | Other: Exercise with pilates ballVarious 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. |
| Without exercise | No intervention | –The children in this group are not included in any kind of exercise/sport program during 6 weeks. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- having a birth year 2015 or 2016.
Key exclusion criteria (3 listed)
- Having cognitive, physical and/or orthopedic problem
- Any pain which may prevent doing exercise
- Having visual and/or auditory loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with pilates ballPilates 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. | Other | Pilates Ball Exercises |
Primary outcome
Dynamic balance
Time frame: change from baseline at 6 weeks
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.
3 secondary outcomes
Static balance
Time frame: change from baseline at 6 weeks
Reaction time
Time frame: change from baseline at 6 weeks
Dual task performance
Time frame: change from baseline at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Derived from this study: PubMed 35514277Obuz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zehra Güçhan Topcu, Dr. study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with pilates ball in people with Healthy, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic balance (time frame: change from baseline at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.