Comparative Study of High Intensity Interval Training and... | NCT02143453

Studies
Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity

NCT02143453

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

May 21, 2014Estimated

Enrollment

39Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Endurance training
High intensity interval 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

May 2014

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

Aug 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

May 18, 2014

First Submission Date that Met QC Criteria

May 20, 2014

First Posted Date

May 21, 2014Estimated

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

May 20, 2014

Last Update Posted Date

May 21, 2014Estimated

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

Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise training mode is still unclear. In this study, the investigators compared the health-related effects of high intensity interval training versus endurance training in obese children.

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

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High intensity interval training	Experimental		Other: High intensity interval training
Endurance training	Experimental		Other: Endurance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurance training	Other	30 to 60-minute continuous exercise at 80% of the peak heart rate	Endurance training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
body mass index (BMI)		12 weeks
aerobic conditioning (VO2max)		12 weeks
insulin sensitivity (HOMA-index)		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 8 and 12 years
Body mass index (BMI) = 95th percentile, according to the First National Health and Nutrition Examination Survey
no pharmacological treatment
no evidence of metabolic, hormonal, orthopedic, and cardiovascular disease at the time of the study's commencement
no participation in any regular exercise training program (except physical education classes, two days a week) at least 6 months before the commencement of the study and throughout the protocol.

Exclusion Criteria:

non-obese participants
physically active participants
participants with cardiovascular diseases or any other condition that could preclude the participation in the the exercise training program

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Gualano, Professor	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital (School of Medicine, University of Sao Paulo)		São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D009043	Motor Activity
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000076663	Endurance Training
D000072696	High-Intensity Interval 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