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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06198231
Other study ID # REC/RCR&AHS/23/0758
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date February 5, 2024

Study information

Verified date January 2024
Source Riphah International University
Contact Imran amjad, PhD
Phone 9233224390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 9 Years
Eligibility Inclusion Criteria: - Children between the ages of 6 and 9 years - Both male and female students. - Students with normal BMI. - Students willingness for participation. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates exercises
Pilates exercises
Flexibility ,strength and endurance excercises
flexibility ,strength and endurance excercises

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 8 weeks
Primary 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). 8 weeks
Secondary 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). 8 weeks
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