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Effect of the High Impact Exercise on Bone Density in Prepuberal Girls
1 other identifier
interventional
276
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFebruary 11, 2016
February 1, 2016
9 months
June 30, 2015
February 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone mineral density (BMD) are presented for the total Body total bone mineral density
whole body whole Amount of mineral matter per square centimeter of bones.
36 weeks
Study Arms (2)
High Impact Exercise
EXPERIMENTALweight bearing exercises, jumps, plyometric exercises
Low Impact Exercise
SHAM COMPARATORWalking, Strength training, Cycling, Yoga.
Interventions
In these workouts, both feet leave the ground at the same time.
A workout is low-impact if at least one of your feet remains in contact with the ground at all times.
Eligibility Criteria
You may qualify if:
- Girls between ages 8 to 10
- Tanner I
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (9)
Bass SL, Saxon L, Daly RM, Turner CH, Robling AG, Seeman E, Stuckey S. The effect of mechanical loading on the size and shape of bone in pre-, peri-, and postpubertal girls: a study in tennis players. J Bone Miner Res. 2002 Dec;17(12):2274-80. doi: 10.1359/jbmr.2002.17.12.2274.
PMID: 12469922BACKGROUNDSayers A, Mattocks C, Deere K, Ness A, Riddoch C, Tobias JH. Habitual levels of vigorous, but not moderate or light, physical activity is positively related to cortical bone mass in adolescents. J Clin Endocrinol Metab. 2011 May;96(5):E793-802. doi: 10.1210/jc.2010-2550. Epub 2011 Feb 16.
PMID: 21325463BACKGROUNDHernandez CJ, Beaupre GS, Carter DR. A theoretical analysis of the relative influences of peak BMD, age-related bone loss and menopause on the development of osteoporosis. Osteoporos Int. 2003 Oct;14(10):843-7. doi: 10.1007/s00198-003-1454-8. Epub 2003 Aug 7.
PMID: 12904837BACKGROUNDFuchs RK, Bauer JJ, Snow CM. Jumping improves hip and lumbar spine bone mass in prepubescent children: a randomized controlled trial. J Bone Miner Res. 2001 Jan;16(1):148-56. doi: 10.1359/jbmr.2001.16.1.148.
PMID: 11149479BACKGROUNDKontulainen SA, Hughes JM, Macdonald HM, Johnston JD. The biomechanical basis of bone strength development during growth. Med Sport Sci. 2007;51:13-32. doi: 10.1159/000103002.
PMID: 17505117BACKGROUNDRauch F, Schoenau E. Changes in bone density during childhood and adolescence: an approach based on bone's biological organization. J Bone Miner Res. 2001 Apr;16(4):597-604. doi: 10.1359/jbmr.2001.16.4.597.
PMID: 11315987BACKGROUNDGrimston SK, Willows ND, Hanley DA. Mechanical loading regime and its relationship to bone mineral density in children. Med Sci Sports Exerc. 1993 Nov;25(11):1203-10.
PMID: 8289606BACKGROUNDWitzke KA, Snow CM. Effects of plyometric jump training on bone mass in adolescent girls. Med Sci Sports Exerc. 2000 Jun;32(6):1051-7. doi: 10.1097/00005768-200006000-00003.
PMID: 10862529BACKGROUNDMacKelvie KJ, McKay HA, Petit MA, Moran O, Khan KM. Bone mineral response to a 7-month randomized controlled, school-based jumping intervention in 121 prepubertal boys: associations with ethnicity and body mass index. J Bone Miner Res. 2002 May;17(5):834-44. doi: 10.1359/jbmr.2002.17.5.834.
PMID: 12009014BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANA KARINA SARMIENTO, DDS
FUNDACION SANTA FE DE BOGOTA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ORAL AND MAXILLOFACIAL SURGEON
Study Record Dates
First Submitted
June 30, 2015
First Posted
July 2, 2015
Study Start
February 1, 2016
Primary Completion
November 1, 2016
Study Completion
May 1, 2017
Last Updated
February 11, 2016
Record last verified: 2016-02