- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07393789
A Multicomponent Physical Activity Intervention Effect on Weekly Steps and Physical Fitness in Preadolescents
A Multicomponent Physical Activity Intervention Effect on Weekly Steps and Physical Fitness in Preadolescents: A Pretest-Posttest Study and Randomized Control Trial
This study examines the effects of a 16-week structured physical activity program on physical fitness, steps number, and body mass index in children aged 8 to 10 years.
Participants were randomly assigned to either an intervention group that participated in the physical activity program or a control group that continued with their usual daily activities without additional intervention.
Physical fitness outcomes include standing broad jump, handgrip strength, and 20-meter shuttle run performance. Body mass index is calculated from measured height and body mass.
The goal of the study is to determine whether participation in a multicomponent physical activity intervention leads to greater improvements in physical fitness, steps number, and body composition compared with no additional intervention.
Study Overview
Status
Intervention / Treatment
Detailed Description
This randomized controlled trial investigated the effects of a multicomponent physical activity intervention on physical fitness, steps number, and body mass index in preadolescent children.
Children aged 8 to 10 years were recruited from a primary school setting and randomly allocated to either an intervention group or a control group. The intervention group participated in a structured physical activity program and motivational strategies lasting 16 weeks, while the control group continued their regular daily routines and school activities without additional intervention activities provided by the study.
The physical activity program consisted of planned sessions designed to develop muscular strength, cardiorespiratory endurance, speed, and coordination through age-appropriate exercises and games.
Assessments were conducted before and after the intervention period. Physical fitness was evaluated using the standing broad jump (lower-body muscular power), handgrip strength (upper-body muscular strength), and the 20-meter shuttle run test (cardiorespiratory fitness). Body mass index was calculated using measured body mass and height.
The primary objective of the study was to determine whether children participating in the intervention demonstrate greater improvements in physical fitness and body mass index compared with children in the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 8 to 10 years.
- Enrollment in regular primary school.
- Written informed consent obtained from parent or legal guardian.
- Ability to participate in physical education and physical activity.
Exclusion Criteria:
- Medical conditions or physical disabilities that limit participation in physical activity.
- Acute illness or injury at the time of testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Activity Intervention Group
Participants receive a 16-week structured multicomponent physical activity program.
|
Structured physical activity sessions and motivational procedures designed to improve muscular strength, cardiorespiratory fitness, speed, and coordination.
|
|
No Intervention: Control Group
Participants continue their usual daily activities without additional intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip Strength
Time Frame: Baseline and 16 weeks
|
Handgrip Strength in kg
|
Baseline and 16 weeks
|
|
Standing Broad Jump Distance
Time Frame: Baseline and 16 weeks
|
Assessment of lower-body muscular power measured in centimeters
|
Baseline and 16 weeks
|
|
20-Meter Shuttle Run Performance
Time Frame: Baseline and 16 weeks
|
20-Meter Shuttle Run result in seconds
|
Baseline and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: Baseline and 16 weeks
|
BMI is calculated by dividing weight in kilograms by height in meters squared.
|
Baseline and 16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- COMPASS-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multicomponent Physical Activity Program
-
Pontificia Universidad Catolica de ValparaisoAgencia Nacional de Investigación y DesarrolloCompletedPhysical Activity | Sleep | Exercise | Health Promotion | Physical Fitness | Sedentary BehaviorsChile
-
University of BarcelonaUniversity of Pittsburgh; Germans Trias i Pujol Hospital; Fundació La Marató... and other collaboratorsCompleted
-
Edge Hill UniversityWest Lancashire Sport Partnership; West Lancashire Leisure TrustCompleted
-
China Medical University HospitalCompletedFrailty | Aging | Physical InactivityTaiwan
-
Hospital de la RiberaUnknown
-
Universidad Santo TomasEmory University; Universidad Pública de Navarra; Universidad de Granada; University... and other collaboratorsCompletedObesity | Lipid Metabolism Disorders | Mental Health Wellness 1 | Body Composition, Beneficial | Metabolic Syndrome X
-
Elena Pérez Expósito, MDNot yet recruiting
-
University Hospital, Clermont-FerrandRecruiting
-
Universidad de MurciaCompletedPhysical Activity | Frail Elderly Syndrome | AgingSpain
-
Case Western Reserve UniversityNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States