NCT02143453

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 18, 2014

Last Update Submit

May 20, 2014

Conditions

Keywords

exerciseoverweightchildren

Outcome Measures

Primary Outcomes (3)

  • body mass index (BMI)

    12 weeks

  • aerobic conditioning (VO2max)

    12 weeks

  • insulin sensitivity (HOMA-index)

    12 weeks

Study Arms (2)

High intensity interval training

EXPERIMENTAL
Other: High intensity interval training

Endurance training

EXPERIMENTAL
Other: Endurance training

Interventions

30 to 60-minute continuous exercise at 80% of the peak heart rate

Endurance training

3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.

High intensity interval training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital (School of Medicine, University of Sao Paulo)

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

ObesityMotor ActivityOverweight

Interventions

Endurance TrainingHigh-Intensity Interval Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bruno Gualano, Professor

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2014

First Posted

May 21, 2014

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations