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Prevention of Osteoporosis: Effects of Mini-trampoline Training on the Bone Remodeling (TRAMBONE)

Primary Purpose

Perimenopausal Bone Loss, Postmenopausal Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
physical activity
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perimenopausal Bone Loss

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sport and Exercise Research Unit, Palermo University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

non-exercise group (control group)

exercise group

Arm Description

The control group not performed physical activity for a total of 20-weeks.

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.

Outcomes

Primary Outcome Measures

Serum bone remodelling markers
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks
Serum bone matabolism markers
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks
Plasma concentrations of Gastrointestinal peptides
GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks

Secondary Outcome Measures

body mass index (BMI)
Weight (Kg) Hight (m) BMI (kg/m2) All these measurements will be assessed at baseline and after 20weeks
body composition
lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 20weeks
insulin
measured in plasma will be assessed at baseline and after 20 weeks
glucose
measured in plasma will be assessed at baseline and after 20 weeks
triglicerises
measured in plasma will be assessed at baseline and after 20 weeks
HDL
measured in plasma will be assessed at baseline and after 20 weeks
Cholesterol
measured in plasma will be assessed at baseline and after 20 weeks

Full Information

First Posted
June 8, 2021
Last Updated
June 25, 2021
Sponsor
University of Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT04942691
Brief Title
Prevention of Osteoporosis: Effects of Mini-trampoline Training on the Bone Remodeling
Acronym
TRAMBONE
Official Title
Sport and Prevention of Bone Resorption
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perimenopausal Bone Loss, Postmenopausal Osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The control group not performed physical activity during the time of the study. In the exercise group SuperJump® training was performed for three times a week, each session lasting 60 minutes for a total of 20-weeks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-exercise group (control group)
Arm Type
No Intervention
Arm Description
The control group not performed physical activity for a total of 20-weeks.
Arm Title
exercise group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
physical activity
Other Intervention Name(s)
SuperJump® Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum bone remodelling markers
Description
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks
Time Frame
20 WEEKS
Title
Serum bone matabolism markers
Description
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks
Time Frame
20 WEEKS
Title
Plasma concentrations of Gastrointestinal peptides
Description
GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks
Time Frame
20 WEEKS
Secondary Outcome Measure Information:
Title
body mass index (BMI)
Description
Weight (Kg) Hight (m) BMI (kg/m2) All these measurements will be assessed at baseline and after 20weeks
Time Frame
20 WEEKS
Title
body composition
Description
lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 20weeks
Time Frame
20 WEEKS
Title
insulin
Description
measured in plasma will be assessed at baseline and after 20 weeks
Time Frame
20 WEEKS
Title
glucose
Description
measured in plasma will be assessed at baseline and after 20 weeks
Time Frame
20 WEEKS
Title
triglicerises
Description
measured in plasma will be assessed at baseline and after 20 weeks
Time Frame
20 WEEKS
Title
HDL
Description
measured in plasma will be assessed at baseline and after 20 weeks
Time Frame
20 WEEKS
Title
Cholesterol
Description
measured in plasma will be assessed at baseline and after 20 weeks
Time Frame
20 WEEKS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrizia Proia, PhD
Organizational Affiliation
Faculty of Sport and Physical Education, University of Palermo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sport and Exercise Research Unit, Palermo University
City
Palermo
ZIP/Postal Code
90144
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
36247958
Citation
Vasto S, Amato A, Proia P, Caldarella R, Cortis C, Baldassano S. Dare to jump: The effect of the new high impact activity SuperJump on bone remodeling. A new tool to maintain fitness during COVID-19 home confinement. Biol Sport. 2022 Oct;39(4):1011-1019. doi: 10.5114/biolsport.2022.108993. Epub 2021 Dec 30.
Results Reference
derived

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Prevention of Osteoporosis: Effects of Mini-trampoline Training on the Bone Remodeling

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