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

Sport and Prevention 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.

Study Overview

• Status: Completed
• Conditions: Perimenopausal Bone Loss; Postmenopausal Osteopenia
• Intervention / Treatment: Other: physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90144
    • Sport and Exercise Research Unit, Palermo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: non-exercise group (control group); The control group not performed physical activity for a total of 20-weeks.
Experimental: exercise group; 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.	Other: physical 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.; Other Names: SuperJump® Training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index (BMI)	Weight (Kg) Hight (m) BMI (kg/m2) All these measurements will be assessed at baseline and after 20weeks	20 WEEKS
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	20 WEEKS
insulin	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS
glucose	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS
triglicerises	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS
HDL	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS
Cholesterol	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS

Collaborators and Investigators

• Sponsor: University of Palermo
• Investigators: Principal Investigator: Patrizia Proia, PhD, Faculty of Sport and Physical Education, University of Palermo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
• Other Study ID Numbers: TRAMP2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No