- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04942691
Prevention of Osteoporosis: Effects of Mini-trampoline Training on the Bone Remodeling (TRAMBONE)
25. juni 2021 oppdatert av: Patrizia Proia, University of Palermo
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Palermo, Italia, 90144
- Sport and Exercise Research Unit, Palermo University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: non-exercise group (control group)
The control group not performed physical activity for a total of 20-weeks.
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Eksperimentell: 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.
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Serum bone remodelling markers
Tidsramme: 20 WEEKS
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bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks
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20 WEEKS
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Serum bone matabolism markers
Tidsramme: 20 WEEKS
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PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks
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20 WEEKS
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Plasma concentrations of Gastrointestinal peptides
Tidsramme: 20 WEEKS
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GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks
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20 WEEKS
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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body mass index (BMI)
Tidsramme: 20 WEEKS
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Weight (Kg) Hight (m) BMI (kg/m2) All these measurements will be assessed at baseline and after 20weeks |
20 WEEKS
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body composition
Tidsramme: 20 WEEKS
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lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 20weeks
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20 WEEKS
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insulin
Tidsramme: 20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
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20 WEEKS
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glucose
Tidsramme: 20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
|
20 WEEKS
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triglicerises
Tidsramme: 20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
|
20 WEEKS
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HDL
Tidsramme: 20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
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20 WEEKS
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Cholesterol
Tidsramme: 20 WEEKS
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measured in plasma will be assessed at baseline and after 20 weeks
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20 WEEKS
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Patrizia Proia, PhD, Faculty of Sport and Physical Education, University of Palermo
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2019
Primær fullføring (Faktiske)
31. januar 2020
Studiet fullført (Faktiske)
3. mars 2020
Datoer for studieregistrering
Først innsendt
8. juni 2021
Først innsendt som oppfylte QC-kriteriene
25. juni 2021
Først lagt ut (Faktiske)
28. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. juni 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2021
Sist bekreftet
1. juni 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TRAMP2021
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
produkt produsert i og eksportert fra USA
Nei
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