The KOMOtini BONE Study: Evaluation of the Osteogenic Potential of Sports (KOMO-BONE)

June 27, 2017 updated by: Ioannis G. Fatouros

The KOMOtini BONE Study: Evaluation of Sports-Related Osteogenic Potential in School-Aged Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Healthy, previously untrained, pre-pubertal boys and girls (N=335) were assigned to 16 different groups: 1) physical education, i.e. children participated only school in physical education classes (control group), 2) football (soccer) training, 3) basketball training, 4) volleyball training, 5) wrestling training, 6) martial arts training, 7) tennis training, 8) track and field training, 9) taekwondo training, 10) rhythmic gymnastics training, 11) artistic gymnastics training, 12) dance training, 13) swimming training, 14) climbing training, 15) two weight-bearing training modes, and 16) one weight-bearing and one non-weight bearing activity. Exercise training was performed three times per week for nine months and each training session had a 60-minute duration (except for the physical education classes at school in the control group). Anthropometric measurements (body height, body mass, and length and circumferences of various body segments), blood sampling, measurements of body composition (using dual X-ray energy absorptiometry or DEXA and skinfold calibers), bone measurements (bone density and bone mineral content at lumbar spine, both hips, both wrists and whole body using DEXA), and performance (cardiorespiratory fitness, muscle strength, muscle power, flexibility and motor ability) were performed at baseline and after the completion of a 9-month training intervention. Nutritional intake and habitual physical activity were measured at baseline, mid-training and post-training (using diet recalls and accelerometry, respectively). Intensity and volume of training was measured once every three months using heart rate monitoring, accelerometry, Global Positioning System (GPS) devices and jump measurement. Furthermore, two other studies were also performed as a part of this project: a) assessment of physical activity during physical education classes for primary school (using accelerometry, GPS instrumentation and jump measurement) and b) a smaller number of participants in the football, track and field, swimming and tennis training groups provided blood samples before and after a training session at baseline.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
335

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Komotini, Greece, 69100
        • Laboratory of Physical Education and Sports, Democritus University of Thrace, School of Physical Education & Sports Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria

  • 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.)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: School physical education class
Children who participated only in their school physical activity classes only for the entire school year.
Other: School physical education class
Children participated only in school physical education classes only.
EXPERIMENTAL: Taekwondo
Children who participated in organized Taekwondo training for the entire school year.
Other: Taekwondo
Children participated only in taekwondo training only.
EXPERIMENTAL: Martial arts
Children who participated in organized Martial arts training for the entire school year.
Other: Martial arts
Children participated only in martial arts training only.
EXPERIMENTAL: Climbing
Children who participated in organized climbing training for the entire school year.
Other: Climbing
Children participated only in climbing training only.
EXPERIMENTAL: Volleyball
Children who participated in organized volleyball training for the entire school year.
Other: Volleyball
Children participated only in volleyball training only.
EXPERIMENTAL: Artistic gymnastics
Children who participated in organized artistic gymnastics training for the entire school year.
Other: Artistic gymnastics
Children participated only in artistic gymnastics training only.
EXPERIMENTAL: Swimming
Children who participated in organized swimming training for the entire school year.
Other: Swimming
Children participated only in swimming training only.
EXPERIMENTAL: Dance
Children who participated in organized dance training for the entire school year.
Other: Dance
Children participated only in dance training only.
EXPERIMENTAL: Basketball
Children who participated in organized basketball training for the entire school year.
Other: Basketball
Children participated only in basketball training only.
EXPERIMENTAL: Wrestling
Children who participated in organized wrestling training for the entire school year.
Other: Wrestling
Children participated only in wrestling training only.
EXPERIMENTAL: Football (soccer)
Children who participated in organized football (soccer) training for the entire school year.
Other: Football (soccer)
Children participated only in football (soccer) training only.
EXPERIMENTAL: Rhythmic gymnastics
Children who participated in organized rhythmic gymnastics training for the entire school year.
Other: Rhythmic gymnastics
Children participated only in rhythmic gymnastics training only.
EXPERIMENTAL: Track and field
Children who participated in organized track and field training for the entire school year.
Other: Track and field
Children participated only in track and field training only.
EXPERIMENTAL: Tennis
Children who participated in organized tennis training for the entire school year.
Other: Tennis
Children participated only in tennis training only.
EXPERIMENTAL: Combination of activities 1
Children who participated in two different weight-bearing activities for the entire school year.
Other: Combination of activities 1
Children participated in two weight-bearing activities.
EXPERIMENTAL: Combination of activities 2
Children who participated in one weight-bearing and in one non weight-bearing activity for the entire school year.
Other: Combination of activities 2
Children participated in one weight-bearing activity and in one non weight-bearing activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in bone mineral content
Time Frame: At baseline and 9 months.
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
Time Frame: At baseline and 9 months.
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
Time Frame: At baseline and 9 months.
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
Time Frame: At baseline and 9 months.
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
Time Frame: At baseline and 9 months.
Using a shuttle run test
At baseline and 9 months.
Changes in muscle power performance of the lower limbs
Time Frame: At baseline and 9 months.
Using long jump test, standing long jump test, countermovement jump test and the Abalakov jump.
At baseline and 9 months.
Changes in flexibility performance
Time Frame: At baseline and 9 months.
Using the sit and reach test
At baseline and 9 months.
Changes in muscle strength
Time Frame: At baseline and immediately after the completion of training.
Using handgrip dynamometry (left and right arm)
At baseline and immediately after the completion of training.
Changes in motor performance
Time Frame: At baseline and 9 months.
Using a standard motor ability test battery
At baseline and 9 months.
Changes in stature (cm)
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in seated height (cm)
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in body mass (kg)
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in body mass index (BMI)
Time Frame: At baseline and 9 months.
Calculated as body mass (kg) divided by the height (m) squared.
At baseline and 9 months.
Changes in arm span
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in tibia length
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in biacromial length
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in chest width
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in waist circumference
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in hip circumference
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in forearm length
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in hand length
Time Frame: At baseline and 9 months.
At baseline and 9 months.
Changes in body fat mass
Time Frame: At baseline and 9 months.
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
Time Frame: At baseline and 9 months.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in sexual maturation
Time Frame: At baseline and 9 months.
Sexual maturation was assessed using the Tanner scale with stages of sexual maturation, orchidometer for boys. Potentially sexual maturation will be assessed also using measurement of hormonal concentration in the blood (if budget allows).
At baseline and 9 months.
Changes in diet intake
Time Frame: At baseline, after 4,5 months of training and after 9 months of training.
Food intake was measured using diet recalls. Participants and their parents were instructed how to record the type and the quantity of solid and liquid foods consumed daily. Daily caloric intake as well daily intake of all nutrients was estimated using a nutritional software.
At baseline, after 4,5 months of training and after 9 months of training.
Changes in habitual physical activity
Time Frame: At baseline, after 4,5 months of training and after 9 months of training.
Daily habitual physical activity was measured using an accelerometer.
At baseline, after 4,5 months of training and after 9 months of training.
Changes in training intensity
Time Frame: At baseline, after 4,5 months of training and after 9 months of training.
Training intensity was measured in two consecutive training sessions for each sport activity at three time points during the intervention. Training intensity was assessed using the following: a) heart rate responses using heart rate monitors, b) accelerometry (except for swimming), c) GPS instrumentation (global positioning system) for outdoor activities only.
At baseline, after 4,5 months of training and after 9 months of training.
Changes in training volume
Time Frame: At baseline, after 4,5 months of training and after 9 months of training.
Training volume was measured in two consecutive training sessions for each sport activity at three time points during the intervention. Training volume was measured using the following: a) total distance covered using GPS instrumentation and accelerometry for outdoor activities, b) accelerometry for indoor activities, c) recording of total meters covered during a session for swimming and d) total vertical jump number.
At baseline, after 4,5 months of training and after 9 months of training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ioannis G. Fatouros

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Democritus University of Thrace

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Antonis Kambas, Democritus University of Thrace
  • Principal Investigator: Diamanda Leontsini, Democritus University of Thrace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DUTH-UTH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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