NCT01580319

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

1.7 years

First QC Date

June 30, 2011

Last Update Submit

May 7, 2012

Conditions

ObesityHypercholesterolemiaHigh Blood PressureSedentary Lifestyle

Keywords

obesitycholesterolcholesterol, LDLcholesterol, HDLblood glucoseTriglycerideC-Reactive Protein - hsblood pressurephysical activitySedentary Lifestyle

Outcome Measures

Primary Outcomes (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 (taken at end of study) are assessed for a external research (blind for randomization) to judge the individual outcome.

    These measurement were taken at end of followup (27th week)

Study Arms (2)

Control

NO INTERVENTION

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

Exercise

EXPERIMENTAL

Participants receive a physical exercise plan to play at home

Other: physical exercise

Interventions

physical exerciseOTHER

150 minutes per week

Also known as: physical activity, exercise
Exercise

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 17 years
  • obesity
  • high cholesterol

You may not qualify if:

  • congenital heart diseases
  • less than 6 or more than 17 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia / Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

Location

MeSH Terms

Conditions

ObesityHypercholesterolemiaHypertensionSedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Claudia C Cesa, MS

    Instituto de Cardiologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master´s Degree

Study Record Dates

First Submitted

June 30, 2011

First Posted

April 19, 2012

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

BR(1)