Perimenopausal Bone LossTRAMBONENCT04942691
Prevention of Osteoporosis: Effects of Mini-trampoline Training on the Bone Remodeling
A study testing physical activity in people with Perimenopausal Bone Loss and Postmenopausal Osteopenia, run by University of Palermo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Bone Loss, Postmenopausal Osteopenia
- What is being tested?
- physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 3 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian
- age: 18-55 years
- currently injury free
- Body mass index between 18.5 and 28 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- physical activity
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityOther
Also called SuperJump® Training
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.
| Study group | Role | What they receive |
|---|---|---|
| non-exercise group (control group) | No intervention | The control group not performed physical activity for a total of 20-weeks. |
| exercise group | Experimental | 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. Receives: Other: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum bone remodelling markers
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks
Measured: 20 WEEKS
Serum bone matabolism markers
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks
Measured: 20 WEEKS
Plasma concentrations of Gastrointestinal peptides
GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks
Measured: 20 WEEKS
Secondary outcomes (7)
body mass index (BMI)
Weight (Kg)
Hight (m)
BMI (kg/m2)
All these measurements will be assessed at baseline and after 20weeks
Measured: 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
Measured: 20 WEEKS
insulin
measured in plasma will be assessed at baseline and after 20 weeks
Measured: 20 WEEKS
glucose
measured in plasma will be assessed at baseline and after 20 weeks
Measured: 20 WEEKS
triglicerises
measured in plasma will be assessed at baseline and after 20 weeks
Measured: 20 WEEKS
HDL
measured in plasma will be assessed at baseline and after 20 weeks
Measured: 20 WEEKS
Cholesterol
measured in plasma will be assessed at baseline and after 20 weeks
Measured: 20 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Sep 2019
- Primary completion31 Jan 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perimenopausal Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrizia Proia, University of Palermo
- Investigators
- Patrizia Proia, PhD, Principal investigator, Faculty of Sport and Physical Education, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942691
- Sponsor's protocol ID
- TRAMP2021
- Acronym
- TRAMBONE
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36247958
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sport and Prevention of Bone Resorption
- ClinicalTrials.gov ID
- NCT04942691
- Acronym / sponsor ID
- TRAMBONE / TRAMP2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| non-exercise group (control group) | No intervention | –The control group not performed physical activity for a total of 20-weeks. |
| exercise group | Experimental | Other: physical activityThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Caucasian
- age: 18-55 years
- currently injury free
- Body mass index between 18.5 and 28 kg/m2
Key exclusion criteria (6 listed)
- bone fracture within the previous year
- use of medication or suffering from any condition known to affect bone metabolism
- pregnancy
- breastfeeding
- current smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activityAlso: SuperJump® Trainingtraining 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 | exercise group |
Primary outcome
Serum bone remodelling markers
Time frame: 20 WEEKS
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks
Serum bone matabolism markers
Time frame: 20 WEEKS
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks
Plasma concentrations of Gastrointestinal peptides
Time frame: 20 WEEKS
GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks
7 secondary outcomes
body mass index (BMI)
Time frame: 20 WEEKS
body composition
Time frame: 20 WEEKS
insulin
Time frame: 20 WEEKS
glucose
Time frame: 20 WEEKS
triglicerises
Time frame: 20 WEEKS
HDL
Time frame: 20 WEEKS
Cholesterol
Time frame: 20 WEEKS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Derived from this study: PubMed 36247958Vasto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrizia Proia, PhD principal investigator
Faculty of Sport and Physical Education, University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with Perimenopausal Bone Loss and Postmenopausal Osteopenia, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum bone remodelling markers (time frame: 20 WEEKS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.