NCT02488122

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

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

June 30, 2015

Last Update Submit

February 9, 2016

Conditions

Keywords

Bone Mineral DensityIsometric ExerciseBone Growth

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

EXPERIMENTAL

weight bearing exercises, jumps, plyometric exercises

Other: High Impact Exercise

Low Impact Exercise

SHAM COMPARATOR

Walking, Strength training, Cycling, Yoga.

Other: Low Impact Exercise

Interventions

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

High Impact Exercise

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

Low Impact Exercise

Eligibility Criteria

Age8 Years - 10 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

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: 12469922BACKGROUND
  • 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.

    PMID: 21325463BACKGROUND
  • 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.

    PMID: 12904837BACKGROUND
  • 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.

    PMID: 11149479BACKGROUND
  • 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.

    PMID: 17505117BACKGROUND
  • 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.

    PMID: 11315987BACKGROUND
  • 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.

    PMID: 8289606BACKGROUND
  • 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.

    PMID: 10862529BACKGROUND
  • 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.

    PMID: 12009014BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • ANA KARINA SARMIENTO, DDS

    FUNDACION SANTA FE DE BOGOTA

    PRINCIPAL INVESTIGATOR

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