NCT04942691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

June 8, 2021

Last Update Submit

June 25, 2021

Conditions

Perimenopausal Bone LossPostmenopausal Osteopenia

Outcome Measures

Primary Outcomes (3)

  • Serum bone remodelling markers

    bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 20weeks

    20 WEEKS

  • Serum bone matabolism markers

    PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after 20weeks

    20 WEEKS

  • Plasma concentrations of Gastrointestinal peptides

    GLP-1, GLP-2, GIP, PYY, Ghrelin will be assessed at baseline and after 20weeks

    20 WEEKS

Secondary Outcomes (7)

  • body mass index (BMI)

    20 WEEKS

  • body composition

    20 WEEKS

  • insulin

    20 WEEKS

  • glucose

    20 WEEKS

  • triglicerises

    20 WEEKS

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: physical activity

Interventions

physical activityOTHER

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.

Also known as: SuperJump® Training
exercise group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian
  • age: 18-55 years
  • currently injury free
  • Body mass index between 18.5 and 28 kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Exercise Research Unit, Palermo University

Palermo, 90144, Italy

Location

Related Publications (1)

  • 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.

    PMID: 36247958DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Patrizia Proia, PhD

    Faculty of Sport and Physical Education, University of Palermo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 28, 2021

Study Start

September 1, 2019

Primary Completion

January 31, 2020

Study Completion

March 3, 2020

Last Updated

June 28, 2021

Record last verified: 2021-06

Locations

IT(1)