Effects of Whole Body Vibration Exercise on Metabolic Sys... | NCT01635673

Studies
Effects of Whole Body Vibration Exercise on Metabolic Systems in Latino Boys

NCT01635673

Sponsor

University of Southern California

Status

Completed

Last Update Posted

Jul 9, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Effects of Whole Body Vibration Exercise on Metabolic Systems

Interventions

Exercise intervention

Countries

United States

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

May 2011

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

May 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jul 3, 2012

First Submission Date that Met QC Criteria

Jul 6, 2012

First Posted Date

Jul 9, 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

Jul 6, 2012

Last Update Posted Date

Jul 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Todd Schroeder, Principal Investigator, University of Southern CaliforniaPrincipal Investigator

Lead Sponsor

University of Southern CaliforniaOTHER

Collaborators

Not provided

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 determine if whole body vibration exercise improves insulin/glucose dynamics and bone metabolism in Latino Boys.

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
Control Group	No Intervention	A group that continues with their normal daily activities for the duration of the study
Exercise Group	Experimental	This group exercises 3 times each week	Other: Exercise intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise intervention	Other	Whole body vibration exercise 3 times per week	Exercise Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood insulin	Change in basal insulin levels	Baseline and week 10

Secondary Outcomes

Measure	Description	Time Frame
Bone Density	Change in bone mineral density	Baseline and week 10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Boy 8-10 years of age
Tanner Stage I
Age and gender BMI > 85th percentile
Hispanic descent( all four grandparents of Hispanic descent)

Exclusion Criteria:

Acute or chronic illness
Any condition known to influence body composition, or insulin/glucose dynamics
Musculoskeletal disease, injury, or orthopedic condition that would prevent exercise

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Todd Schroeder, PhD	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USC Biokinesiology and Physical Therapy, Clinical Exercise Research Center		Los Angeles	California	90033	United States