Bone Mineral ContentKOMO-BONENCT03201302
The KOMOtini BONE Study: Evaluation of the Osteogenic Potential of Sports
A study testing School physical education class, Taekwondo and Martial arts in people with Bone Mineral Content and Bone Density, run by Ioannis G. Fatouros at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Mineral Content, Bone Density, Bone Turnover Markers
- What is being tested?
- School physical education class, Taekwondo and Martial arts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2013to Dec 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Physical Education and Sports, Democritus University of Thrace, School of Physical Education & Sports Sciences
Komotini, 69100
About this study
Official title: 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.
Read the 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.
- Being tested
- School physical education class, Taekwondo, Martial arts, Climbing, Volleyball
- Keywords
- bone, childhood, pre-adolescence, bone turnover markers, sclerostin, sports, physical activity, nutrition
- Medical subject headings
- Sclerosteosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School physical education classOther
Children participated only in school physical education classes only.
TaekwondoOther
Children participated only in taekwondo training only.
Martial artsOther
Children participated only in martial arts training only.
ClimbingOther
Children participated only in climbing training only.
VolleyballOther
Children participated only in volleyball training only.
Artistic gymnasticsOther
Children participated only in artistic gymnastics training only.
SwimmingOther
Children participated only in swimming training only.
DanceOther
Children participated only in dance training only.
BasketballOther
Children participated only in basketball training only.
WrestlingOther
Children participated only in wrestling training only.
Football (soccer)Other
Children participated only in football (soccer) training only.
Rhythmic gymnasticsOther
Children participated only in rhythmic gymnastics training only.
Track and fieldOther
Children participated only in track and field training only.
TennisOther
Children participated only in tennis training only.
Combination of activities 1Other
Children participated in two weight-bearing activities.
Combination of activities 2Other
Children participated in one weight-bearing activity and in one non weight-bearing activity.
| Study group | Role | What they receive |
|---|---|---|
| School physical education class | Experimental | Children who participated only in their school physical activity classes only for the entire school year. Receives: Other: School physical education class |
| Taekwondo | Experimental | Children who participated in organized Taekwondo training for the entire school year. Receives: Other: Taekwondo |
| Martial arts | Experimental | Children who participated in organized Martial arts training for the entire school year. Receives: Other: Martial arts |
| Climbing | Experimental | Children who participated in organized climbing training for the entire school year. Receives: Other: Climbing |
| Volleyball | Experimental | Children who participated in organized volleyball training for the entire school year. Receives: Other: Volleyball |
| Artistic gymnastics | Experimental | Children who participated in organized artistic gymnastics training for the entire school year. Receives: Other: Artistic gymnastics |
| Swimming | Experimental | Children who participated in organized swimming training for the entire school year. Receives: Other: Swimming |
| Dance | Experimental | Children who participated in organized dance training for the entire school year. Receives: Other: Dance |
| Basketball | Experimental | Children who participated in organized basketball training for the entire school year. Receives: Other: Basketball |
| Wrestling | Experimental | Children who participated in organized wrestling training for the entire school year. Receives: Other: Wrestling |
| Football (soccer) | Experimental | Children who participated in organized football (soccer) training for the entire school year. Receives: Other: Football (soccer) |
| Rhythmic gymnastics | Experimental | Children who participated in organized rhythmic gymnastics training for the entire school year. Receives: Other: Rhythmic gymnastics |
| Track and field | Experimental | Children who participated in organized track and field training for the entire school year. Receives: Other: Track and field |
| Tennis | Experimental | Children who participated in organized tennis training for the entire school year. Receives: Other: Tennis |
| Combination of activities 1 | Experimental | Children who participated in two different weight-bearing activities for the entire school year. Receives: Other: Combination of activities 1 |
| Combination of activities 2 | Experimental | Children who participated in one weight-bearing and in one non weight-bearing activity for the entire school year. Receives: Other: Combination of activities 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At baseline and 9 months.
Changes in cardiorespiratory performance
Using a shuttle run test
Measured: 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.
Measured: At baseline and 9 months.
Changes in flexibility performance
Using the sit and reach test
Measured: At baseline and 9 months.
Changes in muscle strength
Using handgrip dynamometry (left and right arm)
Measured: At baseline and immediately after the completion of training.
Changes in motor performance
Using a standard motor ability test battery
Measured: At baseline and 9 months.
Changes in stature (cm)
Measured: At baseline and 9 months.
Changes in seated height (cm)
Measured: At baseline and 9 months.
Changes in body mass (kg)
Measured: At baseline and 9 months.
Changes in body mass index (BMI)
Calculated as body mass (kg) divided by the height (m) squared.
Measured: At baseline and 9 months.
Changes in arm span
Measured: At baseline and 9 months.
Changes in tibia length
Measured: At baseline and 9 months.
Changes in biacromial length
Measured: At baseline and 9 months.
Changes in chest width
Measured: At baseline and 9 months.
Changes in waist circumference
Measured: At baseline and 9 months.
Changes in hip circumference
Measured: At baseline and 9 months.
Changes in forearm length
Measured: At baseline and 9 months.
Changes in hand length
Measured: 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).
Measured: 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).
Measured: At baseline and 9 months.
Secondary outcomes (5)
Changes in sexual maturation
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).
Measured: At baseline and 9 months.
Changes in diet intake
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.
Measured: At baseline, after 4,5 months of training and after 9 months of training.
Changes in habitual physical activity
Daily habitual physical activity was measured using an accelerometer.
Measured: At baseline, after 4,5 months of training and after 9 months of training.
Changes in training intensity
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.
Measured: At baseline, after 4,5 months of training and after 9 months of training.
Changes in training volume
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.
Measured: At baseline, after 4,5 months of training and after 9 months of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startApr 2013
- Primary completionJun 2014
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral ContentStudies 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ioannis G. Fatouros
- Sponsor type
- University, hospital or other
- Collaborators
- Democritus University of Thrace
- Responsible party
- Sponsor-investigator, Ioannis G. Fatouros, University of Thessaly
- Investigators
- Antonis Kambas, Study director, Democritus University of ThraceDiamanda Leontsini, Principal investigator, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201302
- Sponsor's protocol ID
- DUTH-UTH
- Acronym
- KOMO-BONE
- Status last verified
- Jun 2017
- First submitted
- 2 Jan 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The KOMOtini BONE Study: Evaluation of Sports-Related Osteogenic Potential in School-Aged Children
- ClinicalTrials.gov ID
- NCT03201302
- Acronym / sponsor ID
- KOMO-BONE / DUTH-UTH
- Keywords
- bone, childhood, pre-adolescence, bone turnover markers, sclerostin, sports, physical activity, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Ioannis G. FatourosUniversity, hospital or other
- Collaborators
- Democritus University of Thrace
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Jun 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| School physical education class | Experimental | Other: School physical education classChildren who participated only in their school physical activity classes only for the entire school year. |
| Taekwondo | Experimental | Other: TaekwondoChildren who participated in organized Taekwondo training for the entire school year. |
| Martial arts | Experimental | Other: Martial artsChildren who participated in organized Martial arts training for the entire school year. |
| Climbing | Experimental | Other: ClimbingChildren who participated in organized climbing training for the entire school year. |
| Volleyball | Experimental | Other: VolleyballChildren who participated in organized volleyball training for the entire school year. |
| Artistic gymnastics | Experimental | Other: Artistic gymnasticsChildren who participated in organized artistic gymnastics training for the entire school year. |
| Swimming | Experimental | Other: SwimmingChildren who participated in organized swimming training for the entire school year. |
| Dance | Experimental | Other: DanceChildren who participated in organized dance training for the entire school year. |
| Basketball | Experimental | Other: BasketballChildren who participated in organized basketball training for the entire school year. |
| Wrestling | Experimental | Other: WrestlingChildren who participated in organized wrestling training for the entire school year. |
| Football (soccer) | Experimental | Other: Football (soccer)Children who participated in organized football (soccer) training for the entire school year. |
| Rhythmic gymnastics | Experimental | Other: Rhythmic gymnasticsChildren who participated in organized rhythmic gymnastics training for the entire school year. |
| Track and field | Experimental | Other: Track and fieldChildren who participated in organized track and field training for the entire school year. |
| Tennis | Experimental | Other: TennisChildren who participated in organized tennis training for the entire school year. |
| Combination of activities 1 | Experimental | Other: Combination of activities 1Children who participated in two different weight-bearing activities for the entire school year. |
| Combination of activities 2 | Experimental | Other: Combination of activities 2Children who participated in one weight-bearing and in one non weight-bearing activity for the entire school year. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (6 listed)
- 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.)
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 |
|---|---|---|
| School physical education classChildren participated only in school physical education classes only. | Other | School physical education class |
| TaekwondoChildren participated only in taekwondo training only. | Other | Taekwondo |
| Martial artsChildren participated only in martial arts training only. | Other | Martial arts |
| ClimbingChildren participated only in climbing training only. | Other | Climbing |
| VolleyballChildren participated only in volleyball training only. | Other | Volleyball |
| Artistic gymnasticsChildren participated only in artistic gymnastics training only. | Other | Artistic gymnastics |
| SwimmingChildren participated only in swimming training only. | Other | Swimming |
| DanceChildren participated only in dance training only. | Other | Dance |
| BasketballChildren participated only in basketball training only. | Other | Basketball |
| WrestlingChildren participated only in wrestling training only. | Other | Wrestling |
| Football (soccer)Children participated only in football (soccer) training only. | Other | Football (soccer) |
| Rhythmic gymnasticsChildren participated only in rhythmic gymnastics training only. | Other | Rhythmic gymnastics |
| Track and fieldChildren participated only in track and field training only. | Other | Track and field |
| TennisChildren participated only in tennis training only. | Other | Tennis |
| Combination of activities 1Children participated in two weight-bearing activities. | Other | Combination of activities 1 |
| Combination of activities 2Children participated in one weight-bearing activity and in one non weight-bearing activity. | Other | Combination of activities 2 |
Primary outcome
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.
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.
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.
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).
Changes in cardiorespiratory performance
Time frame: At baseline and 9 months.
Using a shuttle run test
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.
Changes in flexibility performance
Time frame: At baseline and 9 months.
Using the sit and reach test
Changes in muscle strength
Time frame: At baseline and immediately after the completion of training.
Using handgrip dynamometry (left and right arm)
Changes in motor performance
Time frame: At baseline and 9 months.
Using a standard motor ability test battery
Changes in stature (cm)
Time frame: At baseline and 9 months.
Changes in seated height (cm)
Time frame: At baseline and 9 months.
Changes in body mass (kg)
Time frame: 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.
Changes in arm span
Time frame: At baseline and 9 months.
Changes in tibia length
Time frame: At baseline and 9 months.
Changes in biacromial length
Time frame: At baseline and 9 months.
Changes in chest width
Time frame: At baseline and 9 months.
Changes in waist circumference
Time frame: At baseline and 9 months.
Changes in hip circumference
Time frame: At baseline and 9 months.
Changes in forearm length
Time frame: At baseline and 9 months.
Changes in hand length
Time frame: 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).
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).
5 secondary outcomes
Changes in sexual maturation
Time frame: 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.
Changes in habitual physical activity
Time frame: 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.
Changes in training volume
Time frame: At baseline, after 4,5 months of training and after 9 months of training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Antonis Kambas study director
Democritus University of Thrace
Diamanda Leontsini principal investigator
Democritus University of Thrace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School physical education class, Taekwondo and Martial arts in people with Bone Mineral Content and Bone Density, run by Ioannis G. Fatouros at 1 site in Greece.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Changes in bone mineral content (time frame: At baseline and 9 months.). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2017.