Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03454061
Other study ID # TH Project
Secondary ID
Status Completed
Phase N/A
First received February 7, 2018
Last updated February 26, 2018
Start date December 2015
Est. completion date June 2016

Study information

Verified date February 2018
Source University of Palermo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Unlike other European countries, Italian kindergartens do not include the physical education teacher in the school organic personnel. This is frequently associated with the lack of opportunities to perform physical education by preschool children. The aim of this study was to analyse the effects of a specific 16-week-long physical education programme (PEP) of 16-week length on the development of locomotor and object control skills in preschool children.


Description:

We conducted a school-based non-randomised controlled trial to evaluate the effect of a specific 16-week-long physical education program (PEP) on the quotient of gross motor development (QGMD) in preschool children. This study involved 119 children who were clustered in a control group (CG, n= 29, age: 52.1±8.65 months; height: 1.1±0.07 m, body weight: 19.2±5.55 Kg, BMI: 16.9±3.16) and an intervention group (IG, n= 90, age: 57.4±9.42 months; height: 1.1±0.06 m, body weight: 19.3±3.65 Kg, BMI: 16±1.75). Participants were assessed for locomotor ability and object control skills using the Italian version of gross motor development test, before and after the experimental period.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date June 2016
Est. primary completion date May 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Months to 67 Months
Eligibility Inclusion Criteria

- preschool children

Exclusion Criteria:

- Age < 40 months

- Age > 67 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
physical activity
Physical education program (PEP) of 16-week length

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Palermo

Outcome

Type Measure Description Time frame Safety issue
Primary Quotient of gross motor development change Quotient of gross motor development Change from Baseline at 16 weeks
Secondary BMI Body mass index Change from Baseline at 16 weeks
Secondary Weight Weight Change from Baseline at 16 weeks
Secondary Height Height Change from Baseline at 16 weeks
Secondary Object control skills change Object control Change from Baseline at 16 weeks
Secondary Locomotion skills change locomotion Change from Baseline at 16 weeks
See also
  Status Clinical Trial Phase
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Active, not recruiting NCT05143294 - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT05267730 - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT00362076 - The Role of Motion in Infants' Ability to Categorize N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03232606 - Physical Activity of Asthmatic Children
Completed NCT05955755 - The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear N/A
Recruiting NCT04443855 - WASH Benefits Child Development Follow up N/A
Not yet recruiting NCT06335524 - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants N/A
Not yet recruiting NCT05783141 - Prebiotic Effects in Healthy Toddlers N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Completed NCT02800616 - The Healthy Elementary School of the Future N/A
Completed NCT02539251 - Arabic Ages and Stages Questionnaire-III
Completed NCT02242539 - Tools to Improve Parental Recognition of Developmental Deficits in Children N/A
Completed NCT03010306 - CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru N/A
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT00989859 - Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Recruiting NCT00980733 - Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits Phase 3
Terminated NCT04347707 - Building Regulation in Dual Generations N/A