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Not yet recruitingNCT06723470Updated Dec 18, 2024

Effect of Passive Smoking on Functional Capacity, Cognition and Academic Performance in Primary School Children

An observational study in Smoke Exposure and Smokeless Tobacco, sponsored by Egyptian Chinese University. Not yet recruiting. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Egyptian Chinese University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
6 Years to 11 Years
Sex
All
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Study summary

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.

Read the detailed description

This observational study aims to assess the effects of passive smoking on functional capacity, cognitive abilities, and academic performance in primary school children aged 6-11 years. The study will compare two groups: children exposed to secondhand smoke (passive smokers) and children not exposed (non-smokers).

Children in the passive smoking group have one or both parents who have been smoking for at least six years, with moderate to high levels of exposure based on a smoking index. These children will be compared with children in the non-smoking group who are not exposed to secondhand smoke at home or in other environments. The study will focus on three primary outcome areas:

  • **Functional Capacity**: Measured by the 3-Minute Step Test to assess cardiorespiratory fitness and physical performance.
  • **Cognitive Abilities**: Evaluated using the Wechsler Intelligence Scale for Children (WISC-V), which measures various cognitive functions, including verbal comprehension, working memory, and processing speed.
  • **Academic Performance**: Assessed using the Academic Performance Rating Scale (APRS), which provides an evaluation of the child's academic success, attention, and classroom behavior.

This study will not involve any interventions, as it is observational in nature. Instead, it will collect data to identify differences in physical, cognitive, and academic outcomes based on passive smoking exposure. All data collection will occur at baseline, with the assessments conducted in a controlled, quiet environment to minimize distractions.

The sample will consist of 90 children (45 in each group), with participation based on inclusion and exclusion criteria. Children will be selected from primary schools in Cairo, Egypt, where parents have provided informed consent for participation. The study results will contribute valuable insights into the negative effects of secondhand smoke on children's health and development, which can guide health care providers, educators, and families in promoting smoke-free environments for children.

02

Conditions studied

  • Smoke Exposure
  • Smokeless Tobacco

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Keywords

  • Passive Smoking
  • Functional Capacity
  • Cognitive Abilities
  • Academic Performance
  • Children
  • Primary School
  • Physical Fitness
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In context

Tobacco Use

420 studies on the registry are indexed under Tobacco Use; 82 are open to participants now.

This study's planned enrollment of 90 is below the median of 560 across 53 observational studies indexed under Tobacco Use.

Browse Tobacco Use studies →

Lead sponsor

Egyptian Chinese University is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Children aged 6-11 years, enrolled in primary school.
  2. Both genders (male and female).
  3. Healthy children with no musculoskeletal, visual, auditory, or cognitive impairments.
  4. Children whose parents have been smoking for at least 6 years, with moderate to high smoking levels (based on the smoking index).
  5. Children residing in a moderate socioeconomic status.
  6. Children living in Cairo, Egypt.
  7. Children who are able to follow simple commands and participate in assessments.

Exclusion criteria

Exclusion Criteria:

  1. Children with musculoskeletal problems, congenital deformities, visual or auditory defects, learning disabilities, or autism.
  2. Children who are currently taking medications that affect alertness or cognitive function.
  3. 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.
  4. Children who are unable to cooperate or participate in the assessments.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1: Passive Smokers

    This group includes children aged 6-11 years who are exposed to secondhand smoke at home. At least one parent or caregiver is a smoker, with a smoking history of no less than six years. The level of exposure is categorized as moderate to high based on the smoking index (number of cigarettes per day multiplied by years of smoking).

  • Group 2: Non-Smokers

    This group includes children aged 6-11 years who are not exposed to secondhand smoke at home or in other environments. Neither parent nor caregiver is a smoker, ensuring no passive smoke exposure.

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What researchers measure

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).

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06723470
Lead sponsor
Egyptian Chinese University
Responsible party
Nourhan Abdelaleem (Assistant lecturer of Pediatric Physical Therapy, Egyptian Chinese University) — Principal investigator
First posted
Dec 9, 2024
Start date
Dec 15, 2024 (estimated)
Primary completion
Sep 15, 2025 (estimated)
Completion
Dec 15, 2025 (estimated)
Last update
Dec 18, 2024

Study contacts

Nourhan M. Abd El_Aleem
Contact
Nmabdelaleem@ecu.edu.eg
+201091112543

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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