Effect of Passive Smoking on Functional Capacity, Cognition and Academic Performance in Primary School Children
NCT ID: NCT06723470
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
90 participants
OBSERVATIONAL
2024-12-15
2025-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
4. Children who are unable to cooperate or participate in the assessments.
Exclusion Criteria
2. Children who are currently taking medications that affect alertness or cognitive function.
6 Years
11 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Egyptian Chinese University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nourhan Abdelaleem
Assistant lecturer of Pediatric Physical Therapy
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P.T.REC/012/005358
Identifier Type: -
Identifier Source: org_study_id