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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02380664
Other study ID # DEP2011-29093
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 23, 2015
Last updated February 27, 2015
Start date January 2012
Est. completion date December 2015

Study information

Verified date February 2015
Source Universidad de Zaragoza
Contact n/a
Is FDA regulated No
Health authority Spain: CEICA Government of Aragon
Study type Interventional

Clinical Trial Summary

Swimming training is associated with decreased bone mass and lower bone mass acquisition during growth periods, mainly when compared to other weight-bearing sports. Little information is available in adolescents pointing in the same direction but still controversial.

On the other hand, bone strength do not only depends on bone mass but on bone structure and microarchitecture. The cross sectional area, cortex thickness or trabecular density are important aspects of bone health. There are few studies on the effect of swimming on bone architecture of adolescents. This information is relevant for present and future health of adolescents practicing swimming and for all the organizations promoting this sport. Jumping and whole body vibration training programs seem to elicit important osteogenic effects; however, there is little information on this regard in adolescent population, even less in these adolescents with potentially decreased bone acquisition such as swimmers.

The main aims of this research project are therefore, to analyze the effect of swimming training on bone mass, metabolism, structure and architecture in adolescents analyzing possible relationships among them. Secondly, to test whether including short boots of jumping or whole body vibration may be able to palliate the possible deleterious effects of swimming and facilitate a normal or even healthier bone development. And finally to study the durability of training-related bone gains over time.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- Specific for the swimmers: With a history of training at least 3 years for more than 6 hours per week and currently still training

- Specific for the control group: Subjects that do not perform more than 3 hours of physical activity per week

Exclusion Criteria:

- Non-caucasian

- Smoking

- Taking medication affecting bone

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Whole-body vibration (Powerplate®)
Swimmers will perform a 15 minute whole-body vibration training 3 times per week. This intervention will be performed with a Powerplate®. The vibration protocol will be progressive starting with 30 Hz and an amplitude op 4 mm reaching at the end of the protocol 38 Hz and 4 mm amplitude.
Behavioral:
Jumping intervention
Swimmers will perform a jumping intervention, 15 minutes 3 times per week. Jumps will include drop jumps, one leg jumps, squat jumps and countermovement jumps.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Zaragoza

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body composition during 3 years evaluated by dual energy X-ray Change from baseline in body composition at 3 years No
Secondary Change in bone strength and structure evaluated by peripheral quantitative computed tomography Change from baseline in bone strength and structure at 3 years No
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