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Completed

NCT Number: NCT04942691

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sport and Exercise Research Unit, Palermo University

Palermo, 90144, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Other

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.

Other names: SuperJump® Training

Primary outcomes

  1. Serum bone remodelling markers

    Time frame: 20 WEEKS

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

  2. Serum bone matabolism markers

    Time frame: 20 WEEKS

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

  3. 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

  1. body mass index (BMI)

    Time frame: 20 WEEKS

    Weight (Kg)

    Hight (m)

    BMI (kg/m2)

    All these measurements will be assessed at baseline and after 20weeks

  2. body composition

    Time frame: 20 WEEKS

    lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 20weeks

  3. insulin

    Time frame: 20 WEEKS

    measured in plasma will be assessed at baseline and after 20 weeks

  4. glucose

    Time frame: 20 WEEKS

    measured in plasma will be assessed at baseline and after 20 weeks

  5. triglicerises

    Time frame: 20 WEEKS

    measured in plasma will be assessed at baseline and after 20 weeks

  6. HDL

    Time frame: 20 WEEKS

    measured in plasma will be assessed at baseline and after 20 weeks

  7. Cholesterol

    Time frame: 20 WEEKS

    measured in plasma will be assessed at baseline and after 20 weeks

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Sport and Prevention of Bone Resorption

Acronym: TRAMBONE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 28, 2021
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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