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

25. juni 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Palermo, Italien, 90144
        • Sport and Exercise Research Unit, Palermo University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: non-exercise group (control group)
The control group not performed physical activity for a total of 20-weeks.
Eksperimentel: 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.
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 navne:
  • SuperJump® Training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum bone remodelling markers
Tidsramme: 20 WEEKS
bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks
20 WEEKS
Serum bone matabolism markers
Tidsramme: 20 WEEKS
PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks
20 WEEKS
Plasma concentrations of Gastrointestinal peptides
Tidsramme: 20 WEEKS
GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks
20 WEEKS

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
body mass index (BMI)
Tidsramme: 20 WEEKS

Weight (Kg)

Hight (m)

BMI (kg/m2)

All these measurements will be assessed at baseline and after 20weeks

20 WEEKS
body composition
Tidsramme: 20 WEEKS
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
insulin
Tidsramme: 20 WEEKS
measured in plasma will be assessed at baseline and after 20 weeks
20 WEEKS
glucose
Tidsramme: 20 WEEKS
measured in plasma will be assessed at baseline and after 20 weeks
20 WEEKS
triglicerises
Tidsramme: 20 WEEKS
measured in plasma will be assessed at baseline and after 20 weeks
20 WEEKS
HDL
Tidsramme: 20 WEEKS
measured in plasma will be assessed at baseline and after 20 weeks
20 WEEKS
Cholesterol
Tidsramme: 20 WEEKS
measured in plasma will be assessed at baseline and after 20 weeks
20 WEEKS

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Patrizia Proia, PhD, Faculty of Sport and Physical Education, University of Palermo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2019

Primær færdiggørelse (Faktiske)

31. januar 2020

Studieafslutning (Faktiske)

3. marts 2020

Datoer for studieregistrering

Først indsendt

8. juni 2021

Først indsendt, der opfyldte QC-kriterier

25. juni 2021

Først opslået (Faktiske)

28. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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