NCT06943300

Brief Summary

Childhood obesity is a growing concern, with potential consequences for long-term health. The number of obese children has increased more than tenfold in the last forty years. Over the course of their lifetimes, more and more young people worldwide will be exposed to obesity, which will hasten the onset of type 2 diabetes, fatty liver, and cardiovascular problems. Promoting physical activity in children is crucial for maintaining a healthy weight and improving overall well-being. Less than 30% of kids and teenagers worldwide fulfill the recommended daily minimum of 60 minutes of moderate to intense physical activity. Since that most children and adolescents spend a significant amount of time traveling to and from school or attending school, schools may be the best places for interventions. This project will investigate the effectiveness of two common exercise approaches, aerobic training and circuit training, on body mass index (BMI), physical fitness, and quality of life in healthy children. A randomized controlled trial will be conducted, recruiting healthy children within a specific age range 8-12. This study will be conducted in the Leader's Lyceum School.Two experimental groups will be made. Participants will be randomly assigned to either an aerobic training group or a circuit training group. Non-probability convenient sampling technique will be used. The study will include the children from age 8 to 12, both genders, healthy children. Both programs will be implemented for a set duration of 12 weeks, with specific parameters regarding intensity, duration, and exercise types. The project will assess changes in BMI, physical fitness components (e.g., cardiovascular endurance, muscular strength, flexibility), and quality of life through validated measures, including Pediatric Quality of Life Generic Score 4.0 (PedsQL), Physical Fitness Test, Presidential Fitness test and BMI.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

April 17, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

ObesityPhysical ActivityAerobic TrainingCircuit TrainingBody Mass IndexQuality of Life

Outcome Measures

Primary Outcomes (4)

  • Pediatric Quality of Life Generic Score 4.0 (PedsQL)

    The PedsQL 4.0 Generic Core Scales is a standardized tool used to measure health-related quality of life in children aged 2 to 18 years, through self-report and parent proxy-report. It includes 23 items across four domains-physical, emotional, social, and school functioning. Items are rated on a 5-point scale and converted to scores from 0-100, with higher scores indicating better quality of life.The PedsQL 4.0 has demonstrated high reliability, with Cronbach's alpha values typically above 0.70 for subscales and \>0.90 for the total score. It also shows strong validity, effectively distinguishing between healthy children and those with chronic conditions, and is sensitive to changes over time-making it a reliable and valid tool for assessing pediatric quality of life.

    Baseline, 4th week, 8th week, 12th week

  • Physical Fitness Test

    A physical fitness test evaluates key components of fitness such as cardiovascular endurance, muscular strength, muscular endurance, flexibility, and body composition. It helps assess overall physical health and performance. When standardized and properly administered, these tests are generally considered valid (accurately measure fitness components) and reliable (produce consistent results over time).

    Baseline, 4th week, 8th week, 12th week

  • Presidential Fitness Test

    The Presidential Fitness Test was a U.S. school-based program designed to assess children's physical fitness through activities like sit-ups, push-ups, a mile run, and flexibility tests. It aimed to promote health and fitness in youth. It has moderate to good reliability and validity for measuring specific fitness components like strength and endurance. It was generally consistent when properly administered, but less valid as a health-focused tool due to its emphasis on performance over personal progress.

    Baseline, 4th week, 8th week, 12th week

  • Body Mass Index

    The BMI chart classifies individuals based on their body mass index (BMI) into categories like underweight, normal weight, overweight, and obesity. While valid for large population assessments, it doesn't directly measure body fat and may misclassify individuals, such as athletes or older adults. It's reliable for general screening, but additional measures are needed for a more accurate assessment of individual health.

    Baseline, 4th week, 8th week, 12th week

Study Arms (2)

Group A

EXPERIMENTAL

Group A: Experiment Group A (aerobic Group); Children will receive Aerobic training.

Other: Aerboic TrainingOther: Circuit Training

Group B

EXPERIMENTAL

Group B: Experiment Group B (circuit group); Children will receive Circuit training.

Other: Aerboic TrainingOther: Circuit Training

Interventions

Group A will perform Aerobic training exercises will be conducted 2 times per 12 weeks in which the warm up phase for 10 minutes. 30 minutes of aerobic exercise like walking, jogging, cycling, calisthenics, rhythmic exercises, continuous slow running, sit ups and cool down phase for stretching Phase 1: stretching of upper limb, trunk, lower limb muscles for 10 minutes. Phase 2: Individualized walking, jogging, cycling, rhythmic exercises, continuous slow running, sit ups Phase 3: Cool down exercise for 10 minutes.

Group AGroup B

The training program will consist of 10 types of resistance and aerobic exercise and will be done 2 times per week for 12 weeks. Specifically, the resistance exercise program comprises of push-up, squat, crunches, lunge and superman exercise. An aerobic exercise program comprises of light jumping, running on the spot, foot stamping, stepping and jumping jack. Phase 1: In Warm up period, dynamic stretching for 10 minutes. Phase 2: Resistance and aerobic exercise (push-up, squat, crunches, lunge and superman exercise, light jumping, running on the spot, foot stamping, stepping and jumping jack) Phase 3: In cool down period, static stretching for 10 minutes.

Group AGroup B

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ⦁ School Age Children from age 7-12 years
  • Both Genders, Male and Female
  • Healthy and fit children
  • Interventions should be given inside the premises of school
  • Children with normal range BMI: 13.3-24.1
  • Children with presidential fitness score at or above the 85th percentile
  • Children with Quality of Life score: minimum 50

You may not qualify if:

  • ⦁ Any Children havig any mental condition: Depession or Anxiety
  • Visual, vestibular, or balance disorders in the preceding six months
  • Children with any orthotic devices
  • Children undertaking any previous aerobic or circuit training
  • Refusal of any child or parent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ahmadi A, Moheb-Mohammadi F, Navabi ZS, Dehghani M, Heydari H, Sajjadi F, Khodarahmi S. The effects of aerobic training, resistance training, combined training, and healthy eating recommendations on lipid profile and body mass index in overweight and obese children and adolescents: A randomized clinical trial. ARYA Atheroscler. 2020 Sep;16(5):226-234. doi: 10.22122/arya.v16i5.1990.

    PMID: 33889189BACKGROUND

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Circuit-Based Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aniqa Asif, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized controlled trial will be conducted, recruiting healthy children within a specific age range 8-12. This study will be conducted in the Leader's Lyceum School. Two experimental groups will be made. Participants will be randomly assigned to either an aerobic training group or a circuit training group. Non-probability convenient sampling technique will be used. The study will include the children from age 8 to 12, both genders, healthy children. Both programs will be implemented for a set duration of 12 weeks, with specific parameters regarding intensity, duration, and exercise types. The project will assess changes in BMI, physical fitness components (e.g., cardiovascular endurance, muscular strength, flexibility), and quality of life through validated measures, including Pediatric Quality of Life Generic Score 4.0 (PedsQL), Physical Fitness Test, Presidential Fitness test and BMI.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

April 15, 2025

Primary Completion

April 15, 2025

Study Completion

July 14, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share