Effect of Resistance Training on Microvascular, Hemodynam... | NCT01692314

Studies
Effect of Resistance Training on Microvascular, Hemodynamic and Physical Parameters in Obese Adolescents

NCT01692314

Sponsor

Rio de Janeiro State University

Status

Completed

Last Update Posted

Sep 25, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Resistance training

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Sep 2010Actual

Completion Date

May 2012Actual

First Submitted Date

Sep 14, 2012

First Submission Date that Met QC Criteria

Sep 24, 2012

First Posted Date

Sep 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2012

Last Update Posted Date

Sep 25, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ingrid Barbara Ferreira Dias, Principal Investigator, Rio de Janeiro State UniversityPrincipal Investigator

Lead Sponsor

Rio de Janeiro State UniversityOTHER

Collaborators

Name	Class
Rio de Janeiro State Research Supporting Foundation (FAPERJ)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the effect os resistance training on microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart rate, body composition and physical fitness in obese adolescents.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obese adolescents is being compared to control ones	Experimental	Patients underwent to resistance training, three times a week, during three months.	Other: Resistance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistance training	Other		Obese adolescents is being compared to control ones

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microvascular Reactivity		Three months

Secondary Outcomes

Measure	Description	Time Frame
Endothelial function		Three months

Other Outcomes

Measure	Description	Time Frame
Hemodynamic parameters		three months
Imflammatory markers		three months
Body composition

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Tanner pubertal stage of development between three and five
age between 13 up to 17 years old

Exclusion Criteria:

presence of chronic diseases (diabetes mellitus, nephropathy and/or hypertension),
musculoskeletal injury,
smoking and
to be in use of any medication.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eliete Bouskela, Phd	State University of Rio de Janeiro	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory for Clinical and Experimental Research in Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro		Rio de Janeiro	Rio de Janeiro		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided