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

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ClinicalTrials.gov Identifier: NCT01580319
Recruitment Status : Terminated (Difficulty in selecting the sample and follow-up lost.)
First Posted : April 19, 2012
Last Update Posted : May 9, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Hypercholesterolemia High Blood Pressure Sedentary Lifestyle Other: physical exercise

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  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outpatient Strategy of Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
Study Start Date : April 2009
Primary Completion Date : December 2010
Study Completion Date : December 2011


Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
Participants do not receive a physical exercise plan. Participants receive a simple orientations about lifestyle activities.
Experimental: Exercise
Participants receive a physical exercise plan to play at home
Other: physical exercise
150 minutes per week
Other Names:
  • physical activity
  • exercise


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 6 to 17 years
  • obesity
  • high cholesterol

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580319


Locations
Brazil
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, Brazil, 90620-001
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Investigators
Principal Investigator: Claudia C Cesa, MS Instituto de Cardiologia
More Information

Responsible Party: Claudia Ciceri Cesa, Master´s Degree, Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01580319     History of Changes
Other Study ID Numbers: 2994/01
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Claudia Ciceri Cesa, Instituto de Cardiologia do Rio Grande do Sul:
obesity
cholesterol
cholesterol, LDL
cholesterol, HDL
blood glucose
Triglyceride
C-Reactive Protein - hs
blood pressure
physical activity
Sedentary Lifestyle

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hypertension
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases