Back to resultsPrimary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
Primary Purpose
Obesity, Hypercholesterolemia, High Blood Pressure
Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, cholesterol, cholesterol, LDL, cholesterol, HDL, blood glucose, Triglyceride, C-Reactive Protein - hs, blood pressure, physical activity, Sedentary Lifestyle
Eligibility Criteria
Inclusion Criteria:
- 6 to 17 years
- obesity
- high cholesterol
Exclusion Criteria:
- congenital heart diseases
- less than 6 or more than 17 years old
Sites / Locations
- Instituto de Cardiologia / Fundação Universitária de Cardiologia
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Exercise
Arm Description
Participants do not receive a physical exercise plan. Participants receive a simple orientations about lifestyle activities.
Participants receive a physical exercise plan to play at home
Outcomes
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)
These measurement (taken at end of study) are assessed for a external research (blind for randomization) to judge the individual outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT01580319
First Posted
June 30, 2011
Last Updated
May 7, 2012
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01580319
Brief Title
Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
Official Title
Outpatient Strategy of Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in selecting the sample and follow-up lost.
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypercholesterolemia, High Blood Pressure, Sedentary Lifestyle
Keywords
obesity, cholesterol, cholesterol, LDL, cholesterol, HDL, blood glucose, Triglyceride, C-Reactive Protein - hs, blood pressure, physical activity, Sedentary Lifestyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants do not receive a physical exercise plan. Participants receive a simple orientations about lifestyle activities.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Participants receive a physical exercise plan to play at home
Intervention Type
Other
Intervention Name(s)
physical exercise
Other Intervention Name(s)
physical activity, exercise
Intervention Description
150 minutes per week
Primary Outcome Measure Information:
Title
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)
Description
These measurement (taken at end of study) are assessed for a external research (blind for randomization) to judge the individual outcome.
Time Frame
These measurement were taken at end of followup (27th week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
6 to 17 years
obesity
high cholesterol
Exclusion Criteria:
congenital heart diseases
less than 6 or more than 17 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia C Cesa, MS
Organizational Affiliation
Instituto de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Cardiologia / Fundação Universitária de Cardiologia
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90620-001
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
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