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

This study has been terminated.
(Difficulty in selecting the sample and follow-up lost.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580319
First Posted: April 19, 2012
Last Update Posted: May 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Information provided by (Responsible Party):
Claudia Ciceri Cesa, Instituto de Cardiologia do Rio Grande do Sul
  Purpose
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 Intervention
Obesity Hypercholesterolemia High Blood Pressure Sedentary Lifestyle Other: physical exercise

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Claudia Ciceri Cesa, Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:
  • 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.


Enrollment: 27
Study Start Date: April 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: June 30, 2011
First Posted: April 19, 2012
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