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Clinical Trials/NCT04942691
NCT04942691
Completed
Not Applicable

Sport and Prevention of Bone Resorption

University of Palermo1 site in 1 country40 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perimenopausal Bone Loss
Sponsor
University of Palermo
Enrollment
40
Locations
1
Primary Endpoint
Serum bone matabolism markers
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
March 3, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrizia Proia

Associate Professor

University of Palermo

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Serum bone matabolism markers

Time Frame: 20 WEEKS

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

Serum bone remodelling markers

Time Frame: 20 WEEKS

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

Plasma concentrations of Gastrointestinal peptides

Time Frame: 20 WEEKS

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

Secondary Outcomes

  • 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)

Study Sites (1)

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