Skip to main content
Clinical Trials/NCT01580319
NCT01580319TerminatedNot Applicable

Outpatient Strategy of Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity

Instituto de Cardiologia do Rio Grande do Sul2 sites in 1 country27 target enrollmentStarted: April 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
27
Locations
2
Primary Endpoint
Reduction on risk factors for a cardiovascular diseases (reduction on BMI, cholesterol, LDL, glucose, high-sensitivity C-reactive protein, blood pressure and/or increase on HDL)

Study Overview

Brief Summary

This research project is about a physical activity intervention in pediatric outpatients to try control and prevent heart diseases such as hypertension, obesity, high cholesterol.

Detailed Description

Control Group: receive information about health lifestyle Interventional Group: receive a structured plan with exercises to do 3 times per week within 50 minutes.

It is a randomized clinical trial and population are children and adolescents.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 6 to 17 years
  • high cholesterol

Exclusion Criteria

  • congenital heart diseases
  • less than 6 or more than 17 years old

Outcomes

Primary Outcomes

Reduction on risk factors for a cardiovascular diseases (reduction on BMI, cholesterol, LDL, glucose, high-sensitivity C-reactive protein, blood pressure and/or increase on HDL)

Time Frame: These measurement were taken at end of followup (27th week)

These measurement (taken at end of study) are assessed for a external research (blind for randomization) to judge the individual outcome.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claudia Ciceri Cesa

Master´s Degree

Instituto de Cardiologia do Rio Grande do Sul

Study Sites (2)

Loading locations...

Similar Trials