Bone Loss, Age-Related,NCT02488122
Effect of the High Impact Exercise on Bone Density in Prepuberal Girls
A study testing High Impact Exercise and Low Impact Exercise in people with Bone Loss, Age-Related,, run by Fundación Santa Fe de Bogota.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Age-Related,
- What is being tested?
- High Impact Exercise and Low Impact Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Girls between ages 8 to 10
- Tanner I
Who cannot join
- 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)
About this study
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
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.
- Conditions
- Bone Loss, Age-Related,
- Being tested
- High Impact Exercise, Low Impact Exercise
- Keywords
- Bone Mineral Density, Isometric Exercise, Bone Growth
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Impact ExerciseOther
In these workouts, both feet leave the ground at the same time.
Low Impact ExerciseOther
A workout is low-impact if at least one of your feet remains in contact with the ground at all times.
| Study group | Role | What they receive |
|---|---|---|
| High Impact Exercise | Experimental | weight bearing exercises, jumps, plyometric exercises Receives: Other: High Impact Exercise |
| Low Impact Exercise | Sham comparator | Walking, Strength training, Cycling, Yoga. Receives: Other: Low Impact Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionNov 2016 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Because the study has not yet sponsorship.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bone Loss, Age-Related,Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Responsible party
- Principal investigator, ANA KARINA SARMIENTO, Fundación Santa Fe de Bogota
- Investigators
- ANA KARINA SARMIENTO, DDS, Principal investigator, FUNDACION SANTA FE DE BOGOTA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488122
- Sponsor's protocol ID
- FSFBK1
- Status last verified
- Feb 2016
- First submitted
- 30 Jun 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12469922Sayers 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.
PubMed 21325463Hernandez 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.
PubMed 12904837Fuchs 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.
PubMed 11149479Kontulainen 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.
PubMed 17505117Rauch 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.
PubMed 11315987Grimston 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.
PubMed 8289606Witzke 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.
PubMed 10862529MacKelvie 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.
PubMed 12009014
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02488122
- Acronym / sponsor ID
- FSFBK1
- Conditions
- Bone Loss, Age-Related,
- Keywords
- Bone Mineral Density, Isometric Exercise, Bone Growth
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because the study has not yet sponsorship.
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Impact Exercise | Experimental | Other: High Impact Exerciseweight bearing exercises, jumps, plyometric exercises |
| Low Impact Exercise | Sham comparator | Other: Low Impact ExerciseWalking, Strength training, Cycling, Yoga. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Girls between ages 8 to 10
- Tanner I
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Impact ExerciseIn these workouts, both feet leave the ground at the same time. | Other | High Impact Exercise |
| Low Impact ExerciseA workout is low-impact if at least one of your feet remains in contact with the ground at all times. | Other | Low Impact Exercise |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Background: PubMed 12469922Bass 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.
- Background: PubMed 21325463Sayers 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.
- Background: PubMed 12904837Hernandez 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.
- Background: PubMed 11149479Fuchs 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.
- Background: PubMed 17505117Kontulainen 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.
- Background: PubMed 11315987Rauch 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.
- Background: PubMed 8289606Grimston 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.
- Background: PubMed 10862529Witzke 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.
- Background: PubMed 12009014MacKelvie 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.
Related trials for Bone Loss, Age-Related,
Recruiting
Stem Cell Ophthalmology Treatment Study II
Retinal Disease, Age-Related Macular Degeneration
Active, not recruitingPhase 4
Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
Age-Related Osteoporosis
Recruiting
Synbiotic to Attenuate Resorption of the Skeleton
Osteoporosis, Inflammation
Recruiting
Minimally Invasive Sinus Lift Through the Interradicular Septum
Bone Loss, Bone Loss, Age-related
Active, not recruitingPhase 1
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
Non-exudative Age-related Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANA KARINA SARMIENTO, DDS principal investigator
FUNDACION SANTA FE DE BOGOTA
Questions about this trial
What is this clinical trial studying?
A study testing High Impact Exercise and Low Impact Exercise in people with Bone Loss, Age-Related,, run by Fundación Santa Fe de Bogota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (BMD) are presented for the total Body total bone mineral density (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488122, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.