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临床试验/NCT04942691
NCT04942691已完成不适用

Sport and Prevention of Bone Resorption

University of Palermo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Serum bone matabolism markers

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Caucasian
  • age: 18-55 years
  • currently injury free
  • Body mass index between 18.5 and 28 kg/m2

排除标准

  • 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.

结局指标

主要结局

Serum bone matabolism markers

时间窗: 20 WEEKS

PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks

Serum bone remodelling markers

时间窗: 20 WEEKS

bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks

Plasma concentrations of Gastrointestinal peptides

时间窗: 20 WEEKS

GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks

次要结局

  • body mass index (BMI)(20 WEEKS)
  • glucose(20 WEEKS)
  • triglicerises(20 WEEKS)
  • body composition(20 WEEKS)
  • insulin(20 WEEKS)
  • HDL(20 WEEKS)
  • Cholesterol(20 WEEKS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrizia Proia

Associate Professor

University of Palermo

研究点 (2)

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