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

Postmenopausal Osteopenia Clinical Trial

— TRAMBONE  

Official title:

Sport and Prevention of Bone Resorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942691
• Other study ID #: TRAMP2021
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: March 3, 2020

Study information

• Verified date: June 2021
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 3, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis, Postmenopausal
• Perimenopausal Bone Loss
• Postmenopausal Osteopenia

Intervention

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.

Locations

Country	Name	City	State
Italy	Sport and Exercise Research Unit, Palermo University	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum bone remodelling markers	bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks	20 WEEKS
Primary	Serum bone matabolism markers	PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks	20 WEEKS
Primary	Plasma concentrations of Gastrointestinal peptides	GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks	20 WEEKS
Secondary	body mass index (BMI)	Weight (Kg); Hight (m); BMI (kg/m2); All these measurements will be assessed at baseline and after 20weeks	20 WEEKS
Secondary	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
Secondary	insulin	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS
Secondary	glucose	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS
Secondary	triglicerises	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS
Secondary	HDL	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS
Secondary	Cholesterol	measured in plasma will be assessed at baseline and after 20 weeks	20 WEEKS