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

Sport and Prevention of Bone Resorption

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04942691
Acronym
TRAMBONE
Enrollment
40
Registered
2021-06-28
Start date
2019-09-01
Completion date
2020-03-03
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perimenopausal Bone Loss, Postmenopausal Osteopenia

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.

Interventions

OTHERphysical activity

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.

Sponsors

University of Palermo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum bone remodelling markers20 WEEKSbone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks
Serum bone matabolism markers20 WEEKSPTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks
Plasma concentrations of Gastrointestinal peptides20 WEEKSGLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks

Secondary

MeasureTime frameDescription
glucose20 WEEKSmeasured in plasma will be assessed at baseline and after 20 weeks
triglicerises20 WEEKSmeasured in plasma will be assessed at baseline and after 20 weeks
body mass index (BMI)20 WEEKSWeight (Kg) Hight (m) BMI (kg/m2) All these measurements will be assessed at baseline and after 20weeks
Cholesterol20 WEEKSmeasured in plasma will be assessed at baseline and after 20 weeks
HDL20 WEEKSmeasured in plasma will be assessed at baseline and after 20 weeks
body composition20 WEEKSlean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 20weeks
insulin20 WEEKSmeasured in plasma will be assessed at baseline and after 20 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026