- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06765460
Prescription of Exercise in Children
January 2, 2025 updated by: Ángel Morillas Mingorance, University Hospital Virgen de las Nieves
Effectiveness of Medical Prescription of Exercise in Children to Increase Physical Activity Levels.
Most pediatric populations do not meet the physical activity (PA) recommendations set by international organizations.
The effectiveness of casual PA advice provided during medical consultations has not been adequately assessed for its role in fostering this healthy habit.
This study aims to evaluate the effectiveness of medical prescriptions for PA in increasing PA levels in children compared to standard health advice (HA), as well as measuring the effectiveness of these recommendations in reducing daily screen time (ST) in the pediatric population.
A randomized controlled clinical trial with parallel groups was conducted, including 130 participants aged 6 to 14 years.
Data on PA levels (duration and intensity), ST, and anthropometric measures were collected via questionnaire.
Participants were divided into two groups: HA (3 minutes) and medical prescription of exercise [MPE] (10 minutes).
PA levels were assessed at 3 and 12 months, with results recorded using the same questionnaire.
A multivariate data analysis was performed.
Further research is needed to develop effective and sustainable public health interventions to prevent long-term sedentary behavior in children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Both HA and MPE interventions could effectively increase children's PA duration and intensity, resulting in a higher PA classification range.
- An inverse relationship may be identified between ST and PA, suggesting that reducing ST could encourage healthier habits in children.
- Pediatricians play a pivotal role in promoting lifestyle changes through brief yet targeted interventions, significantly influencing children's PA levels and reducing ST. These findings highlight the need for further research to optimize public health initiatives within pediatric care.
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Granada, Spain, 18014
- Avenida de las Fuerzas Armadas, 2, 18014, Granada
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
We included pediatric patients between 6 and 14 years of age who were part of two pediatric PC groups of an urban health centre in Granada (Spain) who attended a face-to-face consultation of any type.
Exclusion Criteria:
chronic or complex pathology preventing moderate or intense physical activity or those who did not give consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Medical prescription of exercise (MPE)
MPE consists of dedicating a specific time to establish a specific and individualized exercise plan for the patient, with the premises of fully assessing their physical fitness, motivation, adaptability to change and the possibility of exercising within their social environment, as well as the achievement of specific objectives within an agreed follow-up period.
|
MPE consists of dedicating a specific time to establish a specific and individualized exercise plan for the patient, with the premises of fully assessing their physical fitness, motivation, adaptability to change and the possibility of exercising within their social environment, as well as the achievement of specific objectives within an agreed follow-up period
|
|
Active Comparator: Health Advice (HA)
providing the patient with information and motivation in line with general international recommendations to try to increase PA levels in their daily life.
This advice can be given in a short period of time (up to three minutes) during any medical consultation
|
HA consists of providing the patient with information and motivation in line with general international recommendations to try to increase PA levels in their daily life.
This advice can be given in a short period of time (up to three minutes) during any medical consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efectiveness of MPE and HA
Time Frame: from enrollment to 12 months
|
test whether brief HA and/or individualized MPE in PC increases physical activity levels in childhood.
|
from enrollment to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
November 1, 2024
Study Registration Dates
First Submitted
December 23, 2024
First Submitted That Met QC Criteria
January 2, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 2, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Zaidin exercises
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Permission to reproduce material from other sources: Specific permissions and related documentation are available upon request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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 Physical Activity
-
Muğla Sıtkı Koçman UniversityEge UniversityCompletedPhysical Activity | Physical Activity Behavior | Physical Activity LevelsTurkey
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Universidad Pedagogica Nacional, ColombiaEnrolling by invitationPhysical Activity | Running | Running Performance | Running Endurance | Physical Activity in Adults | Physical Activity IntensityColombia
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
University of ManitobaResearch ManitobaCompletedPhysical Activity | Physical Activity Self-Definition
-
Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
-
Universidade do PortoActive, not recruitingPhysical Activity | Physical Fitness | Well BeingPortugal
-
Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Pham Ngoc Thach University of MedicineCompletedModerate Physical Activity (MPA) | Vigorous Physical Activity (VPA) | Moderate to Vigorous Physical Activity (MVPA) | Total of Sleep Time (TST)Vietnam
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
Clinical Trials on Medical prescription of exercise
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Unknown
-
Peking University People's HospitalNot yet recruiting
-
Royal Cornwall Hospitals TrustRecruitingBariatric Surgery | PrehabilitationUnited Kingdom
-
Jing MaNot yet recruitingCoronary Heart DiseaseChina
-
Dartmouth-Hitchcock Medical CenterNational Cancer Institute (NCI)Recruiting
-
Endocrinology and Clinical Nutrition Research Center...CompletedFrail Elderly Syndrome | SarcopeniaSpain
-
Istituti Clinici Scientifici Maugeri SpACompletedRehabilitation | Post-cardiac SurgeryItaly
-
Ottawa Hospital Research InstituteCanadian Institutes of Health Research (CIHR)Recruiting
-
University Hospital, CaenCompletedPhysical Activity | Chronic Disease | PrescriptionFrance
-
Peking University Third HospitalNot yet recruitingInfertility, Female | Diminished Ovarian Reserve