Effect of Passive Smoking on Functional Capacity, Cognition and Academic Performance in Primary School Children
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-11
SponsorEgyptian Chinese University
About this trial
This is an observational study that aims to understand the effects of passive smoking (secondhand smoke exposure) on children's health and development. The main question the study seeks to answer is:
How does exposure to secondhand smoke affect the physical fitness, cognitive abilities, and academic performance of primary school children?
The study will compare two groups of children aged 6-11 years: one group exposed to secondhand smoke at home (due to parents or caregivers who smoke) and another group not exposed to secondhand smoke. The children's physical capacity, cognitive skills, and school performance will be assessed through various tests.
The goal of the study is to provide valuable insights into how secondhand smoke may negatively impact children, helping families, schools, and healthcare providers understand the risks and promote healthier, smoke-free environments for children.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 6-11 years, enrolled in primary school.
Both genders (male and female).
Healthy children with no musculoskeletal, visual, auditory, or cognitive impairments.
Children whose parents have been smoking for at least 6 years, with moderate to high smoking levels (based on the smoking index).
Disqualifiers
Children with musculoskeletal problems, congenital deformities, visual or auditory defects, learning disabilities, or autism.
Children who are currently taking medications that affect alertness or cognitive function.
Children who are not exposed to secondhand smoke (non-smokers) but have parents who smoke at very low levels or do not meet the inclusion criteria for passive smoking exposure.
Children who are unable to cooperate or participate in the assessments.
Trial population
The study population consists of 90 primary school children aged 6-11 years, selected from various primary schools in Cairo, Egypt. These children are categorized into two groups: 45 children exposed to secondhand smoke (passive smokers) and 45 children not exposed to secondhand smoke (non-smokers). All children are healthy and without any cognitive, visual, or musculoskeletal impairments. The children in the passive smokers group have parents who have been smoking for at least 6 years with moderate to high levels of smoking exposure. The non-smokers group consists of children who are not exposed to secondhand smoke at home or in their environments. The children's participation is voluntary, with informed consent obtained from parents or guardians.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: Group 1: Passive Smokers
Group B: Group 2: Non-Smokers
Trial outcomes
Primary outcomes
1
Impact of Passive Smoking on Functional Capacity in Primary School Children
Functional capacity will be assessed using the 3-Minute Step Test (3MST). This test measures cardiorespiratory fitness by evaluating the total number of completed step cycles (up and down) within 3 minutes and the heart rate recovery one minute post-exercise. The reported outcomes will include: Number of steps completed (unit: step cycles). Heart rate recovery (unit: beats per minute). These outcomes will be analyzed separately. Higher heart rate recovery values indicate worse cardiorespiratory fitness, whereas more completed step cycles indicate better fitness.
Time frame
At the start of the study (baseline).Secondary outcomes
1
Impact of Passive Smoking on Cognitive Abilities in Primary School Children
Cognitive abilities will be assessed using the Wechsler Intelligence Scale for Children (WISC-V). The WISC-V provides composite scores in five domains: Verbal Comprehension Index (VCI): range 50-150. Working Memory Index (WMI): range 50-150. Processing Speed Index (PSI): range 50-150. Fluid Reasoning Index (FRI): range 50-150. Full-Scale IQ (FSIQ): range 50-150. Higher scores indicate better cognitive functioning in each domain.
Time frame
At the start of the study (baseline).2
Impact of Passive Smoking on Academic Performance in Primary School Children
Academic performance will be assessed using the Academic Performance Rating Scale (APRS). This scale includes 19 items, each rated on a 5-point Likert scale (1 = poor, 5 = excellent). The total score ranges from 19 to 95, with higher scores indicating better academic performance.
Time frame
At the start of the study (baseline).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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