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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488122
Recruitment Status : Suspended (Because the study has not yet sponsorship.)
First Posted : July 2, 2015
Last Update Posted : February 11, 2016
Sponsor:
Collaborator:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by (Responsible Party):
ANA KARINA SARMIENTO, Fundación Santa Fe de Bogota

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.


Condition or disease Intervention/treatment Phase
Bone Loss, Age-Related, Other: High Impact Exercise Other: Low Impact Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: 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
Study Start Date : February 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488122


Sponsors and Collaborators
Fundación Santa Fe de Bogota
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Investigators
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Principal Investigator: ANA KARINA SARMIENTO, DDS FUNDACION SANTA FE DE BOGOTA
Publications:

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Responsible Party: ANA KARINA SARMIENTO, ORAL AND MAXILLOFACIAL SURGEON, Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier: NCT02488122    
Other Study ID Numbers: FSFBK1
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by ANA KARINA SARMIENTO, Fundación Santa Fe de Bogota:
Bone Mineral Density
Isometric Exercise
Bone Growth
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases