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

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01580319
• Collaborator: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil (Other)
• Enrollment: 27
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 0.8

Study Details

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	Phase
Obesity; Hypercholesterolemia; High Blood Pressure; Sedentary Lifestyle	Other: physical exercise	N/A

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
• 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: Apr 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 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) [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

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Claudia Ciceri Cesa, Master´s Degree, Instituto de Cardiologia do Rio Grande do Sul
• ClinicalTrials.gov Identifier: NCT01580319
• Other Study ID Numbers: 2994/01
• First Posted: Apr 19, 2012
• Last Update Posted: May 9, 2012
• Last Verified: May 1, 2012

• Keywords provided by Claudia Ciceri Cesa, Master´s Degree, 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; Hypertension; Hypercholesterolemia

Study Results

No Results Posted as of May 9, 2012