The KOMOtini BONE Study: Evaluation of the Osteogenic Potential of Sports

Athletic Performance Clinical Trial

— KOMO-BONE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03201302
• Other study ID #: DUTH-UTH
• Status: Active, not recruiting
• Phase: N/A
• First received: January 2, 2017
• Last updated: June 27, 2017
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 335
• Est. completion date: December 2017
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletic Performance
• Bone Density
• Bone Mineral Content
• Bone Turnover Markers

Intervention

Other:
• School physical education class
Children participated only in school physical education classes only.
• Taekwondo
Children participated only in taekwondo training only.
• Martial arts
Children participated only in martial arts training only.
• Climbing
Children participated only in climbing training only.
• Volleyball
Children participated only in volleyball training only.
• Artistic gymnastics
Children participated only in artistic gymnastics training only.
• Swimming
Children participated only in swimming training only.
• Dance
Children participated only in dance training only.
• Basketball
Children participated only in basketball training only.
• Wrestling
Children participated only in wrestling training only.
• Football (soccer)
Children participated only in football (soccer) training only.
• Rhythmic gymnastics
Children participated only in rhythmic gymnastics training only.
• Track and field
Children participated only in track and field training only.
• Tennis
Children participated only in tennis training only.
• Combination of activities 1
Children participated in two weight-bearing activities.
• Combination of activities 2
Children participated in one weight-bearing activity and in one non weight-bearing activity.

Locations

Country	Name	City	State
Greece	Laboratory of Physical Education and Sports, Democritus University of Thrace, School of Physical Education & Sports Sciences	Komotini

Sponsors (2)

Lead Sponsor	Collaborator
Ioannis G. Fatouros	Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Changes in cardiorespiratory performance	Using a shuttle run test	At baseline and 9 months.
Primary	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.
Primary	Changes in flexibility performance	Using the sit and reach test	At baseline and 9 months.
Primary	Changes in muscle strength	Using handgrip dynamometry (left and right arm)	At baseline and immediately after the completion of training.
Primary	Changes in motor performance	Using a standard motor ability test battery	At baseline and 9 months.
Primary	Changes in stature (cm)		At baseline and 9 months.
Primary	Changes in seated height (cm)		At baseline and 9 months.
Primary	Changes in body mass (kg)		At baseline and 9 months.
Primary	Changes in body mass index (BMI)	Calculated as body mass (kg) divided by the height (m) squared.	At baseline and 9 months.
Primary	Changes in arm span		At baseline and 9 months.
Primary	Changes in tibia length		At baseline and 9 months.
Primary	Changes in biacromial length		At baseline and 9 months.
Primary	Changes in chest width		At baseline and 9 months.
Primary	Changes in waist circumference		At baseline and 9 months.
Primary	Changes in hip circumference		At baseline and 9 months.
Primary	Changes in forearm length		At baseline and 9 months.
Primary	Changes in hand length		At baseline and 9 months.
Primary	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.
Primary	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	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).	At baseline and 9 months.
Secondary	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.	At baseline, after 4,5 months of training and after 9 months of training.
Secondary	Changes in habitual physical activity	Daily habitual physical activity was measured using an accelerometer.	At baseline, after 4,5 months of training and after 9 months of training.
Secondary	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.	At baseline, after 4,5 months of training and after 9 months of training.
Secondary	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.	At baseline, after 4,5 months of training and after 9 months of training.