CompletedNot Applicable

Effects of Structured Physical Activity Breaks and Free Play in Children With Mild Intellectual Disability

Pakistan22 participantsStarted 2025-04-17

Plain-language summary

Children with mild intellectual disability (MID) typically exhibit delays in both intellectual and adaptive functioning, with the onset occurring during the developmental period. These children often learn new information and skills at a slower pace compared to their peers and frequently struggle academically. Structured physical activity breaks (SPAB) in the classroom are short, planned periods of physical exercise integrated into the school day to enhance children's physical fitness and behavioral outcomes. Free play (FP) in which children may choose and engage in activities at their own pace, establishing creativity, social engagement, and self-regulation. Study includes 22 participants and divided into 2 groups, one group receiving (SPAB) and the other group participating in free play (FP). The physical activity breaks, lasting between 5 to 30 minutes. SPAB group will engage in a sequence of activities. These activities will start with a 5-minute stretch, followed by 5 minutes of marching in place, 30 seconds of jumping an invisible rope, 30 seconds of flapping arms like a bird, 5 minutes of mirroring each other's actions and guessing, 5 minutes of hopping on one foot or jumping on both feet, drawing on the board, guessing the color, and making a circle to play a game in class. In comparison, the FP group will have access to various activity stations within the classroom, allowing children to choose their activities within a 30-minute time frame. The intervention will be implemented 5-days a week for a total of 8-weeks. Gross Motor Development-2 (TGMD-2) use for assessing gross motor skills, the 6-minute walk test use for measuring functional capacity of endurance, and the Strengths and Difficulties Questionnaire (SDQ) use for evaluating behavior. Data analysis will be conducted using SPSS version 27.

Who can participate

Age range

7 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Mild Intellectual Disability i-e mild deficit in intellectual and adaptive functions, having onset in developmental period (24) approximate IQ range of 50 to 69 (25). * ADLs are preserved and complex functions minimally impaired (26). * Attendance of a special educational center; * A medically cleared status from any physical ailment for participation in the baseline examinations. * Children are able/ allowed to interact with the environment and use of resources during free play in school/institute Exclusion Criteria: * Children with chronic medical conditions/ physical disabilities/balance issues/injuries that prevent participation in physical activity * Lack of informed consent from parents' and/or legal guardians' for their children's participation; * Coexisting conditions: autism, Down syndrome, cerebral palsy (CP), any muscular dystrophy, or neurological disorders such as epilepsy or brain damage; * Children with severe motor disability Comorbidities like oncological, rheumatic, orthopedic or cardiac diseases

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TGMD-2 for Gross Motor Skills

Timeframe: 8-weeks.

6MWT for endurance

Timeframe: 8-weeks

Strengths and Difficulties Questionnaire for behavior

Timeframe: 8-weeks

Trial details

NCT IDNCT06943196

SponsorRiphah International University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-17

View on ClinicalTrials.gov More Intellectual Disability, Mild trials