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

NCT ID: NCT02488122

Last Updated: 2016-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Loss, Age-Related,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High Impact Exercise

weight bearing exercises, jumps, plyometric exercises

Group Type EXPERIMENTAL

High Impact Exercise

Intervention Type OTHER

In these workouts, both feet leave the ground at the same time.

Low Impact Exercise

Walking, Strength training, Cycling, Yoga.

Group Type SHAM_COMPARATOR

Low Impact Exercise

Intervention Type OTHER

A workout is low-impact if at least one of your feet remains in contact with the ground at all times.

Interventions

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High Impact Exercise

In these workouts, both feet leave the ground at the same time.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

Fundación Santa Fe de Bogota

OTHER

Sponsor Role lead

Responsible Party

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ANA KARINA SARMIENTO

ORAL AND MAXILLOFACIAL SURGEON

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANA KARINA SARMIENTO, DDS

Role: PRINCIPAL_INVESTIGATOR

FUNDACION SANTA FE DE BOGOTA

References

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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.

Reference Type BACKGROUND
PMID: 12469922 (View on PubMed)

Sayers 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.

Reference Type BACKGROUND
PMID: 21325463 (View on PubMed)

Hernandez 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.

Reference Type BACKGROUND
PMID: 12904837 (View on PubMed)

Fuchs 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.

Reference Type BACKGROUND
PMID: 11149479 (View on PubMed)

Kontulainen 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.

Reference Type BACKGROUND
PMID: 17505117 (View on PubMed)

Rauch 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.

Reference Type BACKGROUND
PMID: 11315987 (View on PubMed)

Grimston 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.

Reference Type BACKGROUND
PMID: 8289606 (View on PubMed)

Witzke 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.

Reference Type BACKGROUND
PMID: 10862529 (View on PubMed)

MacKelvie 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.

Reference Type BACKGROUND
PMID: 12009014 (View on PubMed)

Other Identifiers

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FSFBK1

Identifier Type: -

Identifier Source: org_study_id

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