Prevention of Osteoporosis: Effects of Mini-trampoline Training on the Bone Remodeling (TRAMBONE)
2021年6月25日 更新者:Patrizia Proia、University of Palermo
Sport and Prevention of Bone Resorption
The aim of the project is to study the effects on bone remodeling induced by training carried out with the trampoline in order to evaluate the reduction of the resorption itself and therefore the onset of osteoporosis in women.
研究概览
详细说明
Bone mineral density is modified by various factors and in particular by diet, nutritional status and exercise recommended to preserve or increase bone mass in adults.
The degree of bone formation and resorption can be assessed by measuring bone resorption markers in the blood or urine.
To date, there is no information about the effect of training with an elastic trampoline on the reduction of bone resorption.
The aim of the project is to study the effects on bone remodeling induced by training carried out with the trampoline, in order to evaluate the reduction of the resorption itself and therefore the onset of osteoporosis in women.
To examine whether exercise affects bone remodeling, the C-terminal telopeptide bone resorption markers (CTX) and osteocalcin formation marker will be measured.
For the evaluation of bone metabolism osteocalcin parathyroid hormone, Calcitonin, Vitamin D, Calcium, albumin, Phosphate, Potassium markers will be evaluated.
The markers can be detected in serum.
Women with no previous experience with the trampoline activity will participate in the project randomly assigned to the experimental training group (Jumpers) or to the control group, who will not do any training during the observation period (not Jumpers).
The control group will be inserted in order to compare the data and further verify the efficiency of the treatment.
Blood samples for bone resorption assay will be collected on the first day of training with the trampoline and 20 weeks.
Each training session will be monitored by detecting heart rate (heart rate monitor) and subjective perception of fatigue (Borg scale).
Each subject will be subjected to two venous blood samples taken at the beginning of the observation and at the end.
The samples thus obtained will be transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the experimenters at the laboratories of the Molecular Biology section of the University of Palermo.
Serum and plasma will be obtained from each blood sample.
All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations.
Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study.
Blood samples will be collected from the different groups of study.
Samples will be analyzed and compared for Osteocalcin, parathyroid hormone, CTX, Calcitonin, Vitamin D Calcium, albumin, Phosphate, Potassium.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Palermo、意大利、90144
- Sport and Exercise Research Unit, Palermo University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Caucasian
- age: 18-55 years
- currently injury free
- Body mass index between 18.5 and 28 kg/m2
Exclusion Criteria:
- bone fracture within the previous year
- use of medication or suffering from any condition known to affect bone metabolism
- pregnancy
- breastfeeding
- current smokers
- participation in moderate and high impact-activity for ≥3 h·week before enrolling the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:non-exercise group (control group)
The control group not performed physical activity for a total of 20-weeks.
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实验性的:exercise group
The exercise group performed SuperJump® training that will be performed for three times a week, each session lasting 60 minutes for a total of 20-weeks.
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training with trampoline.
Each session lasted sixty minutes.
Organization: a 5 minutes warm-up with breathing and mobility exercises from upper to lower body, central phase with jumping exercises involving the total body and 5 minutes of cool-down phase with total body active stretching exercise.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Serum bone remodelling markers
大体时间:20 WEEKS
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bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks
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20 WEEKS
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Serum bone matabolism markers
大体时间:20 WEEKS
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PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks
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20 WEEKS
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Plasma concentrations of Gastrointestinal peptides
大体时间:20 WEEKS
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GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks
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20 WEEKS
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
body mass index (BMI)
大体时间:20 WEEKS
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Weight (Kg) Hight (m) BMI (kg/m2) All these measurements will be assessed at baseline and after 20weeks |
20 WEEKS
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body composition
大体时间:20 WEEKS
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lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 20weeks
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20 WEEKS
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insulin
大体时间:20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
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20 WEEKS
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glucose
大体时间:20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
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20 WEEKS
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triglicerises
大体时间:20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
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20 WEEKS
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HDL
大体时间:20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
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20 WEEKS
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Cholesterol
大体时间:20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
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20 WEEKS
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Patrizia Proia, PhD、Faculty of Sport and Physical Education, University of Palermo
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年9月1日
初级完成 (实际的)
2020年1月31日
研究完成 (实际的)
2020年3月3日
研究注册日期
首次提交
2021年6月8日
首先提交符合 QC 标准的
2021年6月25日
首次发布 (实际的)
2021年6月28日
研究记录更新
最后更新发布 (实际的)
2021年6月28日
上次提交的符合 QC 标准的更新
2021年6月25日
最后验证
2021年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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