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

NCT ID: NCT04942691

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-03-03

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.

Conditions

Perimenopausal Bone Loss; Postmenopausal Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

non-exercise group (control group)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

physical activity

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

SuperJump® Training

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Patrizia Proia

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrizia Proia, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Sport and Physical Education, University of Palermo

Locations

Sport and Exercise Research Unit, Palermo University

Palermo, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 36247958 (View on PubMed)

Other Identifiers

TRAMP2021

Identifier Type: -

Identifier Source: org_study_id