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

NCT ID: NCT01580319

Last Updated: 2012-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Hypercholesterolemia High Blood Pressure Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Participants do not receive a physical exercise plan. Participants receive a simple orientations about lifestyle activities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise

Participants receive a physical exercise plan to play at home

Group Type EXPERIMENTAL

physical exercise

Intervention Type OTHER

150 minutes per week

Interventions

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physical exercise

150 minutes per week

Intervention Type OTHER

Other Intervention Names

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physical activity exercise

Eligibility Criteria

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Inclusion Criteria

* 6 to 17 years
* obesity
* high cholesterol

Exclusion Criteria

* congenital heart diseases
* less than 6 or more than 17 years old
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

OTHER

Sponsor Role collaborator

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Claudia Ciceri Cesa

Master´s Degree

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia C Cesa, MS

Role: PRINCIPAL_INVESTIGATOR

Instituto de Cardiologia

Locations

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Instituto de Cardiologia / Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2994/01

Identifier Type: -

Identifier Source: org_study_id

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