Effect of the High Impact Exercise on Bone Density in Prepuberal Girls

February 9, 2016 updated by: ANA KARINA SARMIENTO, Fundación Santa Fe de Bogota

Effect of the High Impact Exercise on Bone Density in Prepuberal Girls in 12 Private Schools in Bogota - Colombia During 2016 - 2017. Open Label Randomized Controlled Trial

Osteoporosis has become a worldwide concern an a matter of public health as osteoporosis is a major contributing factor associated with insufficiency fracture of the spine, wrist and proximal femur, and as a result, can diminish quality of life as well as increase direct and indirect healthcare costs.

The pathophysiology of osteoporosis is based on two main factors; low bone mass and age associated architectural changes within the bone, high impact exercise in childhood can improve the peak bone mass and bone architecture. The evidence suggests that bone adaptation to increased load is optimal in early puberty (Tanner stages I and II) since around 30% of total body adult bone mass is accrued during this period.

However, the optimal exercise program for increasing peak bone mineral content is still unclear. Therefore, the aim of this study is to assess if 15 minutes of high-impact exercise three times per week improve areal bone mineral density assessed by DXA of pre pubertal girls after a ten-month regimen compared to low-impact exercise. This information could highly impact the development of public health policies directed to pre pubertal girls.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

276

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Girls between ages 8 to 10
  • Tanner I

Exclusion Criteria:

  • Precocious menarche (within the selected timeframe)
  • Chronic disorders or medications known to affect bone metabolism or musculoskeletal function.
  • Body Mass Index 30 or higher
  • Regular vigorous physical activity (training more than 8 hours per week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Impact Exercise
weight bearing exercises, jumps, plyometric exercises
Other: High Impact Exercise
In these workouts, both feet leave the ground at the same time.
Sham Comparator: Low Impact Exercise
Walking, Strength training, Cycling, Yoga.
Other: Low Impact Exercise
A workout is low-impact if at least one of your feet remains in contact with the ground at all times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mineral density (BMD) are presented for the total Body total bone mineral density
Time Frame: 36 weeks
whole body whole Amount of mineral matter per square centimeter of bones.
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Santa Fe de Bogota

Collaborators

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Investigators

  • Principal Investigator: ANA KARINA SARMIENTO, DDS, Fundacion Santa Fe de Bogota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSFBK1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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