ChildrenNCT06198231
Effects of Pilates Exercises on Balance and Gait in School Children
A study testing Pilates exercises and Flexibility ,strength and endurance excercises in people with Children, run by Riphah International University at 1 site in Pakistan.
Trial summary
The school children often spend prolonged hours in sedentary activities and may not engage in sufficient physical exercise A sedentary lifestyle among school-going children is a growing concern in modern society. Children are spending more time sitting down and less time being physically active. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Children
- What is being tested?
- Pilates exercises and Flexibility ,strength and endurance excercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 2024
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 6 and 9 years
- Both male and female students.
- Students with normal BMI.
- Students willingness for participation.
Who cannot join
- Students with cognitive impairments.
- Students with conditions such as chronic fatigue, myalgia, limb deformity or any orthopedic condition.
- Students who are currently taking any form of medication for chronic illnesses.
- Students with limb deformities e.g flat foot, genuvelgum, genuvarum and leg length discrepancy.
- Students with any type of psychological problem.
- Children who have participated in similar Pilates or physical therapy exercise programs targeting balance and gait in the past six months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Pilates Exercises on Balance and Gait in School Going Children
The school children often spend prolonged hours in sedentary activities and may not engage in sufficient physical exercise A sedentary lifestyle among school-going children is a growing concern in modern society. Children are spending more time sitting down and less time being physically active. This can lead to a variety of health problems, including obesity, poor posture, and a lack of cardiovascular fitness. Postural control is crucial for children's balance, gait, and functional tasks, and core stability and hip muscle strength play significant roles in maintaining proper posture and facilitating movement. Pilates is a popular exercise program known for improving core strength, balance, flexibility, and posture. Understanding the potential benefits of Pilates exercises on muscle strength and postural control in this population is essential, considering the sedentary lifestyles of many school children. Limited research has examined the effectiveness of Pilates exercises in school-aged children This randomized controlled trial will be conducted in schools in Daska City Govt. girls high school Raj okay Tehsil DASKA, Govt Girls elementary school KOT JANDHU Tehsil DASK e.g over a duration of six months. The sample size will consist of 96 children aged 6 to 9 years, divided equally into a control group and an experimental group. The inclusion criteria specify children without acute illnesses or injuries, within the normal BMI range, and free from cognitive impairments or chronic medication use. The control group will receive exercises that will focus on flexibility, strength, and endurance targeting postural stability for 45 minutes, while the experimental group will receive program of exercises including 15 minutes of conventional exercise along(strengthening, flexibility exercises) with 30 minutes of Pilates excercises including ( back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts) for 3 times a week, of Pilates exercises aimed at improving lower-limb strength, flexibility, and coordination. Assessments will be conducted at baseline, 4th week, and 8th-week using measures such as the Pediatric Berg Balance Scale, walking speed assessment, FRT.
Read the detailed description
The sample size will consist of 96 children aged 6 to 9 years, divided equally into a control group and an experimental group. The inclusion criteria specify children without acute illnesses or injuries, within the normal BMI range, and free from cognitive impairments or chronic medication use. The control group will receive exercises that will focus on flexibility, strength, and endurance targeting postural stability for 45 minutes, while the experimental group will receive program of exercises including 15 minutes of conventional exercise (strengthening, flexibility exercises) along with 30 minutes of Pilates exercises including ( back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts) for 3 times a week. Each session will be started with a 5-minute warm-up and concluded with a 5-minute cool-down. Pilates exercises aimed at improving lower-limb strength, flexibility, and coordination. Assessments will be conducted at baseline, 4th week, and 8th-week using measures such as the Paediatric Berg Balance Scale, walking speed assessment, FRT. This randomized controlled trial will be conducted in schools in Daska City Govt. girls high school Raj okay Tehsil DASKA, Govt Girls elementary school KOT JANDHU Tehsil DASK e.g over a duration of six months.
- Conditions
- Children
- Being tested
- Pilates exercises, Flexibility ,strength and endurance excercises
- Keywords
- Balance, Pilates exercises, Postural control, Randomized control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Pilates exercises
Flexibility ,strength and endurance excercisesOther
flexibility ,strength and endurance excercises
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercises | Experimental | The experimental group will receive the same program of exercises given to the control group, 45 minutes of Pilates exercises (such as back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts).The Pilates exercises will be aimed at improving lower-limb strength, flexibility, and coordination, and they will be performed on a mat, using a medical ball. The focus will be on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed, with a 2-minute rest period between repetitions. Receives: Other: Pilates exercises |
| Flexibility ,strength and endurance excercises | Active comparator | Control group will perform flexibility exercises for the hip (flexors and adductors), knee (flexors and extensors), and calf muscle, with a hold of 15 sec ,5 repetitions. Strengthening exercises for core muscles (curl-ups, prone extension),hip extensors (in prone position), hamstrings, quadriceps (knee extension in high sitting).Walking in all directions, standing on rough and soft surfaces, stepping down and up, walking,standing on one limb with both eyes closed and open. Each session will start with a 5-minute warm-up and 5-minute cool-down, session duration 45 minutes,3 times a week. Receives: Other: Flexibility ,strength and endurance excercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pediatric berg balance scale
The Pediatric Balance Scale (PBS) is an assessment tool consists of 14 different balance tasks that challenge various aspects of balance control, including static and dynamic balance (6) The tasks involve different postural positions, such as sitting, standing, and transferring weight, and may require the child to maintain balance while performing specific movements or tasks. Intra class correlation coefficient (ICC) = 0.998] or individual items (Kappa Coefficients, k = 0.87 to 1.0)
Measured: 8 weeks
walking speed assessment
The walking speed assessment will utilize a 6-minute walk test in which the child will be instructed to walk back and forth in a designated hallway for 6 minutes. They will pivot briskly around cones without hesitations. Participants will be accompanied by the assessor, who will be positioned just behind them without leading or influencing their walking speed. The assessment will be conducted before and after the exercise intervention to assess improvements in basic mobility. Strong test-retest reliability was demonstrated (intra class correlation = 0.97).
Measured: 8 weeks
Secondary outcomes (1)
functional reach test
The test involves the participant standing next to a wall, with their arm at 90 degrees of shoulder flexion and a closed fist. The starting position is recorded, and the participant is instructed to reach forward as far as possible without taking a step. The distance between the starting and ending positions is measured and recorded. Three trials will be performed, and the average of the last two trials will be noted. The reach distance is typically measured in inches. The criteria for stopping the test include the patient's feet lifting off the floor or falling forward. The intra-class correlation coefficient range 0.90 - 0.97).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
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 ChildrenStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kirn arshad, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198231
- Sponsor's protocol ID
- REC/RCR&AHS/23/0758
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franco MR, Grande GHD, Padulla SAT. Effect of pilates exercise for improving balance in older adults (PEDro synthesis). Br J Sports Med. 2018 Feb;52(3):199-200. doi: 10.1136/bjsports-2016-097073. Epub 2016 Nov 4. No abstract available.
PubMed 27815239
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Exercises on Balance and Gait in School Going Children
- ClinicalTrials.gov ID
- NCT06198231
- Acronym / sponsor ID
- REC/RCR&AHS/23/0758
- Conditions
- Children
- Keywords
- Balance, Pilates exercises, Postural control, Randomized control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (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 school children often spend prolonged hours in sedentary activities and may not engage in sufficient physical exercise A sedentary lifestyle among school-going children is a growing concern in modern society. Children are spending more time sitting down and less time being physically active. This can lead to a variety of health problems, including obesity, poor posture, and a lack of cardiovascular fitness. Postural control is crucial for children's balance, gait, and functional tasks, and core stability and hip muscle strength play significant roles in maintaining proper posture and facilitating movement. Pilates is a popular exercise program known for improving core strength, balance, flexibility, and posture. Understanding the potential benefits of Pilates exercises on muscle strength and postural control in this population is essential, considering the sedentary lifestyles of many school children. Limited research has examined the effectiveness of Pilates exercises in school-aged children This randomized controlled trial will be conducted in schools in Daska City Govt. girls high school Raj okay Tehsil DASKA, Govt Girls elementary school KOT JANDHU Tehsil DASK e.g over a duration of six months. The sample size will consist of 96 children aged 6 to 9 years, divided equally into a control group and an experimental group. The inclusion criteria specify children without acute illnesses or injuries, within the normal BMI range, and free from cognitive impairments or chronic medication use. The control group will receive exercises that will focus on flexibility, strength, and endurance targeting postural stability for 45 minutes, while the experimental group will receive program of exercises including 15 minutes of conventional exercise along(strengthening, flexibility exercises) with 30 minutes of Pilates excercises including ( back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts) for 3 times a week, of Pilates exercises aimed at improving lower-limb strength, flexibility, and coordination. Assessments will be conducted at baseline, 4th week, and 8th-week using measures such as the Pediatric Berg Balance Scale, walking speed assessment, FRT.
Detailed description
The sample size will consist of 96 children aged 6 to 9 years, divided equally into a control group and an experimental group. The inclusion criteria specify children without acute illnesses or injuries, within the normal BMI range, and free from cognitive impairments or chronic medication use. The control group will receive exercises that will focus on flexibility, strength, and endurance targeting postural stability for 45 minutes, while the experimental group will receive program of exercises including 15 minutes of conventional exercise (strengthening, flexibility exercises) along with 30 minutes of Pilates exercises including ( back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts) for 3 times a week. Each session will be started with a 5-minute warm-up and concluded with a 5-minute cool-down. Pilates exercises aimed at improving lower-limb strength, flexibility, and coordination. Assessments will be conducted at baseline, 4th week, and 8th-week using measures such as the Paediatric Berg Balance Scale, walking speed assessment, FRT. This randomized controlled trial will be conducted in schools in Daska City Govt. girls high school Raj okay Tehsil DASKA, Govt Girls elementary school KOT JANDHU Tehsil DASK e.g over a duration of six months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Pilates exercises | Experimental | Other: Pilates exercisesThe experimental group will receive the same program of exercises given to the control group, 45 minutes of Pilates exercises (such as back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts).The Pilates exercises will be aimed at improving lower-limb strength, flexibility, and coordination, and they will be performed on a mat, using a medical ball. The focus will be on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed, with a 2-minute rest period between repetitions. |
| Flexibility ,strength and endurance excercises | Active comparator | Other: Flexibility ,strength and endurance excercisesControl group will perform flexibility exercises for the hip (flexors and adductors), knee (flexors and extensors), and calf muscle, with a hold of 15 sec ,5 repetitions. Strengthening exercises for core muscles (curl-ups, prone extension),hip extensors (in prone position), hamstrings, quadriceps (knee extension in high sitting).Walking in all directions, standing on rough and soft surfaces, stepping down and up, walking,standing on one limb with both eyes closed and open. Each session will start with a 5-minute warm-up and 5-minute cool-down, session duration 45 minutes,3 times a week. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 6 and 9 years
- Both male and female students.
- Students with normal BMI.
- Students willingness for participation.
Key exclusion criteria (6 listed)
- Students with cognitive impairments.
- Students with conditions such as chronic fatigue, myalgia, limb deformity or any orthopedic condition.
- Students who are currently taking any form of medication for chronic illnesses.
- Students with limb deformities e.g flat foot, genuvelgum, genuvarum and leg length discrepancy.
- Students with any type of psychological problem.
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 |
|---|---|---|
| Pilates exercisesPilates exercises | Other | Pilates exercises |
| Flexibility ,strength and endurance excercisesflexibility ,strength and endurance excercises | Other | Flexibility ,strength and endurance excercises |
Primary outcome
pediatric berg balance scale
Time frame: 8 weeks
The Pediatric Balance Scale (PBS) is an assessment tool consists of 14 different balance tasks that challenge various aspects of balance control, including static and dynamic balance (6) The tasks involve different postural positions, such as sitting, standing, and transferring weight, and may require the child to maintain balance while performing specific movements or tasks. Intra class correlation coefficient (ICC) = 0.998] or individual items (Kappa Coefficients, k = 0.87 to 1.0)
walking speed assessment
Time frame: 8 weeks
The walking speed assessment will utilize a 6-minute walk test in which the child will be instructed to walk back and forth in a designated hallway for 6 minutes. They will pivot briskly around cones without hesitations. Participants will be accompanied by the assessor, who will be positioned just behind them without leading or influencing their walking speed. The assessment will be conducted before and after the exercise intervention to assess improvements in basic mobility. Strong test-retest reliability was demonstrated (intra class correlation = 0.97).
1 secondary outcome
functional reach test
Time frame: 8 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 13 Jun 2024.
- Background: PubMed 27815239Franco MR, Grande GHD, Padulla SAT. Effect of pilates exercise for improving balance in older adults (PEDro synthesis). Br J Sports Med. 2018 Feb;52(3):199-200. doi: 10.1136/bjsports-2016-097073. Epub 2016 Nov 4. No abstract available.
- 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.
kirn arshad, MS* principal investigator
Riphah International 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 Pilates exercises and Flexibility ,strength and endurance excercises in people with Children, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 6 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 13 Jun 2024. 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 Pakistan. 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?
pediatric berg balance scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT06198231, 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 13 Jun 2024.