Clinical trial NCT04942691: Prevention of Osteoporosis: Effects of Mini-trampoline Training on the Bone Remodeling
Official title: Sport and Prevention of Bone Resorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perimenopausal Bone Loss
Postmenopausal Osteopenia
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Serum bone remodelling markers
timeFrame: 20 WEEKS
measure: Serum bone matabolism markers
timeFrame: 20 WEEKS
measure: Plasma concentrations of Gastrointestinal peptides
timeFrame: 20 WEEKS
Secondary outcomes:
measure: body mass index (BMI)
timeFrame: 20 WEEKS
measure: body composition
timeFrame: 20 WEEKS
measure: insulin
timeFrame: 20 WEEKS
measure: glucose
timeFrame: 20 WEEKS
measure: triglicerises
timeFrame: 20 WEEKS
measure: HDL
timeFrame: 20 WEEKS
measure: Cholesterol
timeFrame: 20 WEEKS
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Sport and Exercise Research Unit, Palermo University
Study officials:
affiliation: Faculty of Sport and Physical Education, University of Palermo
name: Patrizia Proia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.