Skip to main content
Clinical Trials/NCT02488122
NCT02488122SuspendedNot Applicable

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

Fundación Santa Fe de Bogota0 sites276 target enrollmentStarted: February 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Sponsor
Enrollment
276
Primary Endpoint
bone mineral density (BMD) are presented for the total Body total bone mineral density

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
8 Years to 10 Years (Child)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Girls between ages 8 to 10

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Fundación Santa Fe de Bogota
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ANA KARINA SARMIENTO

ORAL AND MAXILLOFACIAL SURGEON

Fundación Santa Fe de Bogota

Similar Trials

Effect of the High Impact Exercise on Bone... | Clinical Trial