NCT02982967

Brief Summary

The purpose of present study was to investigate the effect of 10 weeks of recreational physical activity program on the irisin levels, progenitor endothelial cells and cardiometabolic profile in healthy children. Also, we investigated the correlation between this markers with anthropometric data, body composition, cardiac autonomic balance and physical fitness parameters. We evaluated eighty children aged 6 to 14 participated in the recreational physical activity program by 10 weeks (Duration: 60 minutes; Intensity: 65%-85% heart rate reserve; Frequency: 4 sessions/week). All parameters were evaluated before and after this approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

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

April 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

December 2, 2016

Last Update Submit

December 5, 2016

Conditions

Keywords

childphysical activityirisinEPCs

Outcome Measures

Primary Outcomes (1)

  • improvement in body composition

    10 weeks

Study Arms (1)

Physical Activity

OTHER

Single-arm study with recreational physical activity intervention by 10 weeks (Duration: 60 minutes; Intensity: 65%-85% heart rate reserve; Frequency: 4 sessions/week).

Other: Physical Activity

Interventions

Recreational Physical Activity (Duration: 60 minutes; Intensity: 65%-85% heart rate reserve; Frequency: 4 sessions/week).

Physical Activity

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy Children
  • Both Gender
  • Aged 6 to 14 years

You may not qualify if:

  • Clinical signs of musculoskeletal or orthopedic disorders that prevented them from performing the proposed physical fitness tests.
  • Not completed anthropometric, metabolic or physical fitness assessments in the post-physical activity period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiology Department - Federal University of são Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (1)

  • Souza LV, De Meneck F, Fernandes T, Oliveira EM, Franco MDC. Physical activity intervention improved the number and functionality of endothelial progenitor cells in low birth weight children. Nutr Metab Cardiovasc Dis. 2020 Jan 3;30(1):60-70. doi: 10.1016/j.numecd.2019.08.011. Epub 2019 Aug 30.

MeSH Terms

Conditions

Motor ActivityMetabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria do Carmo Franco, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 6, 2016

Study Start

April 1, 2013

Primary Completion

September 1, 2014

Study Completion

June 1, 2015

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access

Locations