The KOMOtini BONE Study: Evaluation of the Osteogenic Potential of Sports
KOMO-BONE
1 other identifier
interventional
335
1 country
1
Brief Summary
Bone mass develops throughout childhood and adolescence until a peak bone mass is achieved during early adulthood. Fracture risk later in life can be predicted at a large extent by peak bone mass. Occurence of sarcopenia and osteoporosis (i.e. loss of mone mass) during late adulthood has been strongly associated with the degree of bone mineralization during early life. Nearly 50% of total bone mineral content (BMC) reached during adulthood is obtained during pre-adolescence rendering this period critical for skeletal health and is considered as an optimal period for bone/skeletal growth since during this time bones are more adaptable to osteogenic stimuli such as exercise-induced mechanical loading. Organized sport activities and/or nutrition appear to affect profoundly bone mineral density (BMD), BMC, bone geometry, and overall skeletal health during preadolescence offering an effective type of prevention of osteoporosis, a condition very difficult to treat later in life. Evidence suggest that some modes of exercise activities may be more effective (osteogenic) for bone development due to the magnitude and type of mechanical strain placed on long bones causing them to be more dense. Weight-bearing activities (e.g. running, jumping etc.) are believed to be more osteogenic than non-weight bearing activities. However, more research is required in order to determine: i) whether weight-bearing activities are more osteogenic than non weight -bearing activities during childhood and ii) the osteogenic potential of a large number of sport activities used by school-children as compared to a control treatment of no participation in organized sport activities. The present trial attempted to compare a large number of different sport activities in respect to their osteogenic potential based on training variables that are thought to affect osteogenesis while at the same time allows direct comparison of exercise modes that are entirely different. Therefore, the goal of this investigation was to determine the osteogenic potential of a large number of exercise training activities in boys and girls of 8-12 years of age during an entire primary school season.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 28, 2017
June 1, 2017
1.2 years
January 2, 2017
June 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (23)
Changes in bone mineral content
Using a whole body, hip (left and right), lumbar spine, and wrist (left and right) scans performed by a dual-energy x-ray absorptiometry scanner.
At baseline and 9 months.
Changes in bone density
Using a whole body, hip (left and right), lumbar spine, and wrist (left and right) scans performed by a dual-energy x-ray absorptiometry scanner.
At baseline and 9 months.
Changes in area of different regions and sub-regions
Using a whole body, hip (left and right), lumbar spine, and wrist (left and right) scans performed by a dual-energy x-ray absorptiometry scanner.
At baseline and 9 months.
Changes in bone resorption
By measuring blood levels of sclerostin, calcium, phosphorus, magnesium, creatinine, alkaline phosphatase (ALP), vitamin D (if budget allows), serum procollagen type 1 aminoterminal propeptide (P1NP, if budget allows) and isomer of the Carboxy-terminal telopeptide of type 1 collagen (CTX-1, if budget allows).
At baseline and 9 months.
Changes in cardiorespiratory performance
Using a shuttle run test
At baseline and 9 months.
Changes in muscle power performance of the lower limbs
Using long jump test, standing long jump test, countermovement jump test and the Abalakov jump.
At baseline and 9 months.
Changes in flexibility performance
Using the sit and reach test
At baseline and 9 months.
Changes in muscle strength
Using handgrip dynamometry (left and right arm)
At baseline and immediately after the completion of training.
Changes in motor performance
Using a standard motor ability test battery
At baseline and 9 months.
Changes in stature (cm)
At baseline and 9 months.
Changes in seated height (cm)
At baseline and 9 months.
Changes in body mass (kg)
At baseline and 9 months.
Changes in body mass index (BMI)
Calculated as body mass (kg) divided by the height (m) squared.
At baseline and 9 months.
Changes in arm span
At baseline and 9 months.
Changes in tibia length
At baseline and 9 months.
Changes in biacromial length
At baseline and 9 months.
Changes in chest width
At baseline and 9 months.
Changes in waist circumference
At baseline and 9 months.
Changes in hip circumference
At baseline and 9 months.
Changes in forearm length
At baseline and 9 months.
Changes in hand length
At baseline and 9 months.
Changes in body fat mass
Body composition was measured using a dual-energy x-ray absorptiometry scanner (DEXA). DEXA instrumentation allowed the measurement of regional (legs, arms, trunk) weight, body fat (%), and fat mass (kg).
At baseline and 9 months.
Changes in lean body mass
Body composition was measured using a dual-energy x-ray absorptiometry scanner (DEXA). DEXA instrumentation allowed the measurement of regional (legs, arms) weight, lean mass (kg).
At baseline and 9 months.
Secondary Outcomes (5)
Changes in sexual maturation
At baseline and 9 months.
Changes in diet intake
At baseline, after 4,5 months of training and after 9 months of training.
Changes in habitual physical activity
At baseline, after 4,5 months of training and after 9 months of training.
Changes in training intensity
At baseline, after 4,5 months of training and after 9 months of training.
Changes in training volume
At baseline, after 4,5 months of training and after 9 months of training.
Study Arms (16)
School physical education class
EXPERIMENTALChildren who participated only in their school physical activity classes only for the entire school year.
Taekwondo
EXPERIMENTALChildren who participated in organized Taekwondo training for the entire school year.
Martial arts
EXPERIMENTALChildren who participated in organized Martial arts training for the entire school year.
Climbing
EXPERIMENTALChildren who participated in organized climbing training for the entire school year.
Volleyball
EXPERIMENTALChildren who participated in organized volleyball training for the entire school year.
Artistic gymnastics
EXPERIMENTALChildren who participated in organized artistic gymnastics training for the entire school year.
Swimming
EXPERIMENTALChildren who participated in organized swimming training for the entire school year.
Dance
EXPERIMENTALChildren who participated in organized dance training for the entire school year.
Basketball
EXPERIMENTALChildren who participated in organized basketball training for the entire school year.
Wrestling
EXPERIMENTALChildren who participated in organized wrestling training for the entire school year.
Football (soccer)
EXPERIMENTALChildren who participated in organized football (soccer) training for the entire school year.
Rhythmic gymnastics
EXPERIMENTALChildren who participated in organized rhythmic gymnastics training for the entire school year.
Track and field
EXPERIMENTALChildren who participated in organized track and field training for the entire school year.
Tennis
EXPERIMENTALChildren who participated in organized tennis training for the entire school year.
Combination of activities 1
EXPERIMENTALChildren who participated in two different weight-bearing activities for the entire school year.
Combination of activities 2
EXPERIMENTALChildren who participated in one weight-bearing and in one non weight-bearing activity for the entire school year.
Interventions
Children participated only in school physical education classes only.
Children participated only in artistic gymnastics training only.
Children participated only in football (soccer) training only.
Children participated only in rhythmic gymnastics training only.
Children participated in two weight-bearing activities.
Children participated in one weight-bearing activity and in one non weight-bearing activity.
Eligibility Criteria
You may qualify if:
- were 8-12 years and pre-pubertal
- were healthy and had no prior bone fractures or related surgical operation
- had not been involved in organized sport activities previously
- their body fat was \<30%, e) had no history of growth irregularities
- were not receiving agents or drugs that affect bone tissue (e.g. Gonadotropin-Releasing Hormone (GnRH) agonists, antiresorptive, bisphosphonates, etc.)
You may not qualify if:
- had prior bone fractures or related surgical operation
- had been involved in organized sport activities previously
- their body fat was \>30%
- had history of growth irregularities
- were receiving agents or drugs that affect bone tissue (e.g. GnRH agonists, antiresorptive, bisphosphonates, etc.)
- missed more than 10% of training sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ioannis G. Fatouroslead
- Democritus University of Thracecollaborator
Study Sites (1)
Laboratory of Physical Education and Sports, Democritus University of Thrace, School of Physical Education & Sports Sciences
Komotini, 69100, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antonis Kambas
Democritus University of Thrace
- PRINCIPAL INVESTIGATOR
Diamanda Leontsini
Democritus University of Thrace
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 2, 2017
First Posted
June 28, 2017
Study Start
April 1, 2013
Primary Completion
June 1, 2014
Study Completion
December 1, 2017
Last Updated
June 28, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share