Clinical trial NCT03029312: Whole Body Vibration Training in Children With Osteogenesis Imperfecta and Limited Mobility
Official title: Whole Body Vibration as an Osteogenic Treatment for Children With Osteogenesis Imperfecta With Limited Mobility: A Randomised Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteogenesis Imperfecta
Keywords: whole body vibration
Muscle function
Physical activity
bone density
Lead sponsor: Birmingham Women's and Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Royal Manchester Children' s Hospital, Manchester
name: University of Sheffield
First posted: 2017-01-24
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paired randomized controlled study
Primary purpose: TREATMENT

Brief summary: Children with osteogenesis imperfecta (OI) have impaired bone strength, fractures, weak muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may benefit from muscle training that leads to secondary improvement in bone strength (osteogenic treatment). Recent studies in children with cerebral palsy but also OI suggest that Whole Body Vibration Training (WBVT) improves mobility and also bone strength. No randomized controlled trials exist in OI children. This randomized controlled pilot study assesses the effect of 5 months WBVT (2 x 9min/day) on muscle function, mobility, bone structure and density. 24 children \>5 years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a WBVT group and a control group matched by gender and pubertal stage. Main outcome measure is the change in tibial volumetric BMD, secondary outcomes include a variety of bone, mobility and dynamic muscle function variables.

Detailed description: Osteogenesis imperfecta (OI) is a bone fragility disorder with impaired bone strength, fractures, weak muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may not require bisphosphonate therapy but would benefit from muscle training that leads to secondary improvement in bone strength (osteogenic treatment). The mechanostat theory states that bone adapts its strength to mechanical forces mostly imposed by muscle. According to this widely accepted theory, any treatment that strengthens muscle should also strengthen bones. Whole body vibration therapy (WBVT) with side-alternating platforms (Galileo™) uses the body's neuromotor reflex system to train muscles. Recent studies in children with cerebral palsy but also OI suggest that WBVT improves mobility and also bone strength. No randomized controlled trials exist in OI children.

This randomized controlled study assesses the effect of 5 months whole body vibration training (2 x 9min/day) on muscle strength, motor function, bone structure and density. 24 children \>5 years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a WBVT group and a control group matched by gender and pubertal stage. Children with OI will be recruited from specialist clinics in Birmingham, Manchester and Sheffield, as well as via advertisement on the Brittle Bone Society's homepage. Patients will be equipped with side-alternating vibration platforms for home use and train with increasing intensity. Outcome measures are tested pre- and post 5-months intervention. Dynamic muscle function is measured by mechanography (jumping force plates) and mobility by CHAQ questionnaire and a six-minute walk test. Changes in bone structure and density are assessed by DXA and peripheral QCT of the tibia.

Eligibility criteria: Inclusion Criteria:

Patients with mild OI (type 1 and 4; \>5y of age) who need to be at least partly ambulant and have a CHAQ score of greater than 0.13, constituting at least mild disability. Minimum requirement is the ability to rise from a chair.

Informed consent is required from the participant and/or parent/guardian.

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Exclusion Criteria:

* On bisphosphonate treatment for less than 2years (since mobility usually improves during the initial phase treatment).
* Finished bisphosphonate therapy less than 6 months ago
* Recent lower limb fracture \<3months ago, or upper limb fracture which is still in plaster.
* Heart or lung disease, use of steroids (oral, systemic, topical or inhaled, for more than 3 weeks in the last 12 months) or any other bone-active treatment.

Primary outcomes:
measure: Does WBVT increase bone density at the distal tibia
timeFrame: 5 months
Secondary outcomes:
measure: Does WBVT result in an increase in dynamic muscle function
timeFrame: 5 months
measure: Does WBVT result in an increase in muscle mass
timeFrame: 5 months
measure: Does WBVT result in an increase in density
timeFrame: 5 months
measure: Does WBVT result in an increase in density of the tibia
timeFrame: 5 months
measure: Does WBVT result in an increase in bone geometry
timeFrame: 5 months
measure: Does WBVT result in an increase in 6-minute walking distance
timeFrame: 5 months
measure: Does WBVT result in improved disability
timeFrame: 5 months
measure: Does WBVT result in improved balance
timeFrame: 5 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
Study officials:
affiliation: Birmingham Children's Hospital
name: Wolfgang Högler, MD PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hogler W, Scott J, Bishop N, Arundel P, Nightingale P, Mughal MZ, Padidela R, Shaw N, Crabtree N. The Effect of Whole Body Vibration Training on Bone and Muscle Function in Children With Osteogenesis Imperfecta. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2734-2743. doi: 10.1210/jc.2017-00275.