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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:
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
ClinicalTrials.gov Identifier:
NCT01580319
First received: June 30, 2011
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  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 Blind (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:

U.S. FDA Resources

Further study details as provided by 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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 30, 2011
Last Updated: May 7, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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
Obesity
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013