Exercise Intervention in Children Living in a Container City

NCT07394764 | Active Not Recruiting

• 2 other identifiers: Inonu323S479
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Disasters are natural events that deeply affect human life and can lead to psychosocial problems. Major disasters such as earthquakes can also jeopardize children's health both physically and psychologically. Children may suffer neurological, orthopedic, and traumatic injuries, in addition to the trauma of entrapment, displacement, loss of loved ones, and the upheaval of their daily lives during such events. These traumatic experiences can induce mental health issues like anxiety and depression, as well as physical symptoms such as fatigue, sleep disturbances, energy deficiency, and concentration loss. Post-earthquake, there is an observed increase in lifestyle-related illnesses, with individuals in temporary accommodations experiencing reduced physical activity levels, heightening the risk of these conditions. Although the health benefits of physical activity are well-documented, the aftermath of earthquakes can deter motivation for exercise due to housing and environmental challenges. Consequently, specialized strategies are advocated to promote physical activity and enhance individual self-confidence. The unique value of this research project is to explore the psychosocial advantages of physical activity in post-earthquake scenarios for children, emphasize the role of physiotherapists, and develop a model for countries in seismic zones, including our own. The proposal aims to protect and improve the health of children aged 6-10 residing in post-earthquake container cities through a designated station to increase physical activity. This project proposes:

• The creation of a physical activity unit in our country's frequently erected temporary housing for disaster victims, which typically lacks facilities to support children's physical and psychosocial health. This unit is envisioned to serve as a model.
• The design of a motivating and suitable environmental setting within the proposed unit for children whose activity opportunities have been curtailed post-earthquake.
• The role of the unit in safeguarding and enhancing the health of children following a disaster.
• The inclusion of child-specific, programmed, and engaging activities within the unit to boost children's physical performance and enable them to spend their free time productively. The research will be conducted in a container city established in Malatya's center following the earthquakes on February 6, 2023, which houses a significant density of children aged 6-10. The study will involve more children than the number determined by power analysis, divided randomly into experimental and control groups. The experimental group will participate in a program at a physical activity and exercise station established in the container city, under the guidance of physiotherapists. The program will feature diverse and individualized exercise models, with suitable environmental modifications and equipment provided at the exercise station to facilitate age-appropriate activities. A 12-week training program is planned for the experimental group, while the control group will not receive any training. Outcome measures will include assessments of the children's psychosocial health and physical fitness, conducted at the program's inception, the 12th week, and subsequently the 24th week. Upon completion, the project is expected to:
• Enable children in temporary housing to spend their time beneficially through scientifically guided training programs, thereby assuming a protective role.
• Serve as an exemplary model for intervention programs catering to the diverse needs of children requiring physical activity and exercise in temporary housing.
• Prepare the ground for integrating physical activity and exercise station units in future temporary housing established in the wake of natural disasters, thus contributing to disaster management.
• Ensure the stations are cost-effective, accessible, and financially efficient.

Conditions

This Study Focuses on Children Affected by the Earthquake

Keywords

Disaster; physical activity; exercise; psychosocial health; physical fitness; container city

Outcome Measures

Primary Outcomes (10)

• physical fitness

  The physical fitness levels of the participating children will be assessed using the European Fitness Tests (EuroFIT) battery.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

• psycosocial health-quality of life

  Developed in 1999, Pediatric Scale Quality of Life (PEDSQL) scale is designed to assess General Health-Related Quality of Life in children and adolescents aged 2-18 years. It includes both a parent-report form and a self-report form completed by children and adolescents. The scale consists of 23 items and yields scores in three domains: the Total Scale Score (TSS), the Total Physical Health Score (PHHS), and the Total Psychosocial Health Score (PSHS). The PSHS is derived from items assessing emotional, social, and school functioning.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

• psychosocial health-Strengths and Difficulties Questionnaire

  Another instrument used to screen for mental health problems in children and adolescents is the Strengths and Difficulties Questionnaire (SDQ), developed by Robert Goodman in 1997. The SDQ is designed for use with children and adolescents aged 4-16 years. It consists of 25 items and serves as a screening tool for the early identification of psychological difficulties and a range of behavioral and emotional problems in children.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

• psychosocial health - Depression Scale

  The DSM-5 Level 2 Depression Scale - Parent Form assesses depressive symptoms experienced by children over the past 7 days. The scale includes a parent-report form applicable to children aged 6-17 years and a self-report form completed by adolescents aged 11-17 years. In the present study, the parent-report form will be used. The parent form consists of 11 items.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

• psychosocial health - Anxiety Scale

  The DSM-5 Level 2 Anxiety Scale - Parent Form is designed for use in the initial assessment and treatment monitoring of children and adolescents with anxiety disorders. The scale evaluates the severity of anxiety symptoms experienced by children and adolescents during the past 7 days, with higher scores indicating greater anxiety severity. The instrument includes a 10-item parent-report form completed by a parent or guardian for children aged 6-17 years, as well as a 13-item self-report form completed by adolescents aged 11-17 years. In the present study, the parent-report form will be used.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

• psychosocial health-Post-Traumatic Stress Scale

  The Childhood Post-Traumatic Stress Disorder Scale (PEDS), developed by Saylor in 1999, is designed to assess behavioral symptoms associated with Post-Traumatic Stress Disorder in children aged 2-10 years. The scale consists of 21 items and is completed by caregivers. Items are rated on a Likert-type scale, yielding a total score ranging from 0 to 84, with higher scores indicating greater severity of post-traumatic stress symptoms.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

• psychosocial health - Psychiatric Condition Assessment

  The K-SADS-PL, developed by Kaufman and colleagues in 1997 to identify psychiatric conditions in children and adolescents aged 6-18 years, is a semi-structured psychiatric interview that was revised in 2016 in accordance with DSM-5 diagnostic criteria. The interview consists of several stages. The first section collects information on sociodemographic characteristics, presenting complaints, developmental history, health status, and functioning in school and home environments. The second section includes screening questions that assess both past and current psychiatric symptoms, with current symptoms referring to those present within the past two months. The third section consists of assessment and observational findings used to confirm DSM-5 diagnoses. Information obtained from each source is scored separately and subsequently integrated with the clinician's observations to reach the final diagnostic evaluation.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

• Sociodemographic and General Physical Examination Characteristics

  The sociodemographic characteristics of the participating children-including age, sex, school and grade level, family structure, number of siblings, family socioeconomic status, and parental education level-will be assessed using a structured questionnaire. In addition, information related to the earthquake experience (such as losses, school-based support, and peer support) will also be collected. General physical examination findings, including body weight, height, and blood pressure, will be measured and recorded.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention

• psychosocial health - Stress Axis Activities

  Salivary cortisol levels will be measured to determine the stress hormone profiles of the participants. To minimize the effects of confounding factors, cortisol sampling will be conducted between 09:00 and 11:00 a.m. for all participants, as salivary cortisol levels are known to become relatively stabilized after 09:00 a.m. The primary parameter to be evaluated is not the absolute cortisol level itself, but rather the change in state anxiety levels and salivary cortisol concentrations before and after the intervention.

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

• Physical Activity Level

  The Children's Physical Activity Questionnaire will be used to assess the physical activity levels of the participants. This questionnaire was originally developed in Canada as the Physical Activity Questionnaire for Older Children (PAQ-C).

  Baseline, at the end of the 12-week intervention, and at the end of the 24-week intervention.

Study Arms (2)

intervention group

EXPERIMENTAL

This study plans for a 12-week exercise training program, implemented three days a week. Children and families planned for inclusion in the experimental group will receive training on the importance of physical activity, the risks of a sedentary lifestyle, and daily physical activity recommendations, along with brochures. A daily logbook will be kept, and each child's information will be recorded in detail. On designated days, 60-minute sessions will be conducted, combining aerobic and strength training with play-based recreational activities. Each session will consist of 30 minutes of aerobic exercise and 10 minutes of strength training. Warm-up, cool-down, and relaxation exercises will be provided at the beginning and end of each session.

Other: Exercise

control group

NO INTERVENTION

Children in the control group will not receive any exercise training. This group will continue with their routine lives.

Interventions

Exercise OTHER

934 Children and families planned for inclusion in the experimental group will receive training on the importance of physical activity, the risks of a sedentary lifestyle, and daily physical activity recommendations, along with brochures. On designated days, 60-minute sessions will be conducted, combining aerobic and strength training with play-based recreational activities. Each session will consist of 30 minutes of aerobic exercise and 10 minutes of strength training. Warm-up, cool-down, and relaxation exercises will be provided at the beginning and end of each session. The exercise program will be individualized according to the FITTE principle. The FITTE principle involves creating an individual exercise prescription based on the steps (Frequency, Intensity, Type, Time, Enjoy).

Also known as: warm-up exercise, aerobic exercise, strengthening exercise, relaxation exercises, cool-down exercise

intervention group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being between 6-10 years old
• Permanently residing in a container city
• Family and child consent to participate in the study

You may not qualify if:

• Presence of a metabolic disease (celiac disease, diabetes, thyroid disorders, obesity, etc.)
• Presence of a neuromuscular disease (cerebral palsy, muscle diseases, spina bifida, etc.)
• Presence of a cardiopulmonary disease (congenital heart diseases, asthma, cystic fibrosis, etc.)
• BMI percentile value between \<5 and \>99
• History of psychiatric diagnosis and treatment according to DSM-5 criteria
• Having a neurodevelopmental disorder (autism, mental retardation, etc.)
• Having a diagnosis of schizophrenia and bipolar disorder, etc.
• Children who are on chronic medication for any medical reason
• Having hearing, visual, or orthopedic impairment

Sponsors & Collaborators

• Inonu University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Warm-Up Exercise; Cool-Down Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Post-Exercise Recovery Techniques; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR DR.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 6, 2026
• Study Start: September 12, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)