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临床试验/NCT03201302
NCT03201302Unknown不适用

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

Ioannis G. Fatouros2 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
335
试验地点
2
主要终点
Changes in seated height (cm)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

结局指标

主要结局

Changes in seated height (cm)

时间窗: At baseline and 9 months.

Changes in bone density

时间窗: 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 muscle strength

时间窗: At baseline and immediately after the completion of training.

Using handgrip dynamometry (left and right arm)

Changes in motor performance

时间窗: At baseline and 9 months.

Using a standard motor ability test battery

Changes in bone mineral content

时间窗: 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

时间窗: 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

时间窗: 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 muscle power performance of the lower limbs

时间窗: At baseline and 9 months.

Using long jump test, standing long jump test, countermovement jump test and the Abalakov jump.

Changes in cardiorespiratory performance

时间窗: At baseline and 9 months.

Using a shuttle run test

Changes in flexibility performance

时间窗: At baseline and 9 months.

Using the sit and reach test

Changes in stature (cm)

时间窗: At baseline and 9 months.

Changes in body mass (kg)

时间窗: At baseline and 9 months.

Changes in arm span

时间窗: At baseline and 9 months.

Changes in forearm length

时间窗: At baseline and 9 months.

Changes in body mass index (BMI)

时间窗: At baseline and 9 months.

Calculated as body mass (kg) divided by the height (m) squared.

Changes in tibia length

时间窗: At baseline and 9 months.

Changes in biacromial length

时间窗: At baseline and 9 months.

Changes in chest width

时间窗: At baseline and 9 months.

Changes in waist circumference

时间窗: At baseline and 9 months.

Changes in hip circumference

时间窗: At baseline and 9 months.

Changes in hand length

时间窗: At baseline and 9 months.

Changes in body fat mass

时间窗: 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

时间窗: 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).

次要结局

  • 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.)

研究者

发起方
Ioannis G. Fatouros
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ioannis G. Fatouros

Associate Professor

University of Thessaly

研究点 (2)

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