Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000353291
Ethics application status
Approved
Date submitted
22/04/2009
Date registered
25/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Good Vibrations Study: A comparison of whole body
vibration exposure using locked or soft knees in older adults.
Scientific title
Randomized Controlled Trial of Whole Body Vibration Exposure using
Locked or Soft Knees in Older Adults.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia, Osteoporosis, Sarcopenia 4643 0
Condition category
Condition code
Musculoskeletal 4945 4945 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) Whole Body Vibration (WBV) uses high frequency stimuli which are generated by a vibrating platform transmitted through the body where they load the bone and stimulate muscle.
b) participants stand upright with knees either soft or locked. Participants will be randomized into one of the groups (ie locked kness ot soft knees) according to a randomisation plan generated from www.randomization.com by a researcher not directly involved in the study. The trainers will monitor the knee position throughout the training session. An overhead transparency drawn with the correct knee angle for soft knees will be used to enable the correct knee angle is maintained throughout each training session.
c) the duration and frequency of whole body vibration intermittent exposure is 20 minute (alternating 1 minute vibration, 1 minute off; 10 min total vibration exposure) sessions 3 times a week for 26 weeks.
Intervention code [1] 4405 0
Treatment: Devices
Intervention code [2] 4406 0
Prevention
Comparator / control treatment
Sham Whole Body Vibration duration and frequency of sessions 20 minute (1 minute noise without vibration, 1 minute off) sessions 3 times a week for 26 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 5792 0
Bone Mineral Density and Bone Mineral Content will be measured by Dual energy X-ray absorptiometry and periheral quantitative computed tomography
Timepoint [1] 5792 0
At baseline and at 6 months, following commencement of intervention
Primary outcome [2] 5793 0
Muscle Cross Sectional Area will be measured using Dual energy X-ray absorptiometry and peripheral quantitative computed tomography
Timepoint [2] 5793 0
Baseline, 3 Months, and 6 months following commencement of intervention
Primary outcome [3] 5794 0
Muscle Function will be measured by:
a) muscle strength (leg and arm) using 1 Repetition Maximum (RM)
b) muscle power measure as the muscle force/time to lift a load at 20%, 40%, 60%, 70%, 80% and 90% 1 RM
Timepoint [3] 5794 0
Baseline, 3 Months, and 6 months following commencement of intervention
Secondary outcome [1] 241787 0
Balance will be measured using static balance and dynamic posturography, which is measured on a Chattecx Balance Platform. The platform moves in an anterior-posterior (AP) direction (forward-backward) for 30 s under open and eyes closed conditions. The platform also moves in AP tilt (up and down). for 30 s under open and eyes closed conditions. Static balance is measure by single leg stand for 30 s under eyes open and eyes closed conditions.
Timepoint [1] 241787 0
Baseline, 3 Months, and 6 Months following commencement of intervention
Secondary outcome [2] 241788 0
Physical Performance measured by:
a) sit to stand
b) stair climb)
c) habitual gait speed
d) maximal gait speed
e) total distance covered in 6 minutes
Timepoint [2] 241788 0
Baseline, 3 Months, and 6 months following commencement of intervention'

Eligibility
Key inclusion criteria
Adults aged 50 & older (women to be post menopausal for at least one year), normal nutritional status, no cognitive impairment, able to stand unaided for at least 20 minutes and willing to participate in the study. If currently on medications for osteoporosis e.g. bisphosphonates, Vitamin D, calcium, maintain for the duration of the study, and if osteoporosis medication has not changed within the past two months.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindications to resistance exercise testing, contraindications to vibration training, diseases related to bone metabolism other than osteoporosis (e.g. hyperthyroidism) and terminal illness.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Alocation Concealment: Sealed opaque envelopes and central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1620 0
2144
Recruitment postcode(s) [2] 1621 0
2141
Recruitment postcode(s) [3] 1622 0
2137
Recruitment postcode(s) [4] 1623 0
2135
Recruitment postcode(s) [5] 1624 0
2200
Recruitment postcode(s) [6] 1625 0
2143

Funding & Sponsors
Funding source category [1] 4824 0
University
Name [1] 4824 0
University of Sydney
Country [1] 4824 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
75 East St, Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 4515 0
None
Name [1] 4515 0
Address [1] 4515 0
Country [1] 4515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6881 0
Ethics Administration, University of Sydney
Ethics committee address [1] 6881 0
Ethics committee country [1] 6881 0
Australia
Date submitted for ethics approval [1] 6881 0
Approval date [1] 6881 0
Ethics approval number [1] 6881 0
7132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29518 0
Address 29518 0
Country 29518 0
Phone 29518 0
Fax 29518 0
Email 29518 0
Contact person for public queries
Name 12765 0
Dr Rhonda Orr
Address 12765 0
75 East St, Lidcombe, NSW 2141
Country 12765 0
Australia
Phone 12765 0
+61 2 93519475
Fax 12765 0
+61 2 93519204
Email 12765 0
[email protected]
Contact person for scientific queries
Name 3693 0
Dr Rhonda Orr
Address 3693 0
75 East St, Lidcombe, NSW, 2141
Country 3693 0
Australia
Phone 3693 0
+61 2 93519475
Fax 3693 0
+61 2 93519204
Email 3693 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.