Vibration in Boys With a History of Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-09-30

Brief Summary

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Boys aged 9-12 years, with a history of facture will be asked to stand on one of two vibrating platforms for 10 minutes on 5 consecutive days. The investigators will take blood samples before and after the vibration to measure changes in the bone cells.

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Detailed Description

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Fractures in children are common, accounting for 10% of attendances in Accident and Emergency Departments. Research into risk factors for fracture has found that children who have narrower bones and a low bone mass are more likely to fracture than children with larger bones. Studies in postmenopausal women, young women with low bone mass and children with disabling conditions such as cerebral palsy, have shown that up to 10 minutes a day stood on a vibrating platform can significantly increase bone mass.

However little is known of the immediate response of bone to whole body vibration (WBV). The investigators previously investigated the acute bone response in healthy pre-pubertal boys to standing on one of two vibrating platforms for 10 minutes on 1, 3 or 5 consecutive days. This showed a platform dependent reduction in the bone resorption marker CTx pre to post vibration, with an increase in the bone formation marker P1NP over the 8 day study. The investigators would like to look at the response of bone to WBV in pre-pubertal boys who have a history of fracture(s). The investigators will compare this to the investigator's previous data to determine if bone in boys who have previously fractured responds in the same way as bone in boys who have not.

The investigators plan to recruit 24 boys aged 9-12 years who have had a previous fracture to stand on one of two vibrating platforms for 10 minutes on 5 consecutive days. Before and after the period of vibration on days 1, 3, 5, and on days 8 and 12 the investigators will take a blood sample to measure changes in the bone cells. The boys will be asked about the amount of exercise they have participated in over the previous seven days. The findings of this study will be used to direct further research.

Conditions

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Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Platform type 1

12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.

Group Type ACTIVE_COMPARATOR

vibrating platform

Intervention Type DEVICE

Use of two different types of vibrating platform

Platform type 2

12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.

Group Type ACTIVE_COMPARATOR

vibrating platform

Intervention Type DEVICE

Use of two different types of vibrating platform

Interventions

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vibrating platform

Use of two different types of vibrating platform

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Caucasian
* Aged 7-13yrs (pre-pubertal)
* First language English
* History of one or more fracture(s)

Exclusion Criteria

* Pre-existing chronic illness
* Known bone disease
* Current or healing fracture
* Recent (last 12 months) or current treatment likely to affect bone - this does not include inhaled or intermittent oral therapy with steroids for asthma
* Balance problems
* Continuing involvement in more than one other research study

Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes