Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000848505
Ethics application status
Approved
Date submitted
4/08/2015
Date registered
14/08/2015
Date last updated
26/10/2022
Date data sharing statement initially provided
27/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole body vibration for osteoporosis: Shaking up treatment options.
Scientific title
A semi-blind, block-randomised clinical trial investigating the effects of low-intensity whole body vibration (WBV) with or without exercise on risk factors for hip fracture in postmenopausal women.
Secondary ID [1] 287122 0
Nil known
Universal Trial Number (UTN)
U1111-1172-3652
Trial acronym
VIBMOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 295656 0
Hip fractures 295657 0
Osteopenia 295820 0
Vertebral fracture 295821 0
Condition category
Condition code
Musculoskeletal 295935 295935 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. WBV: Participants will stand on the 30 Hz WBV device installed in their home for 10-minutes 5 days per week for 9 months. Compliance is recorded by the device.

Arm 2. HiRIT: Participants will attend Griffith University for a 30-minute high intensity resistance and impact training (HiRIT) session, supervised by a trained exercise physiologist or exercise scientist, twice per week for 9 months. A participant diary will be completed every session.

Arm 3. HiRIT + WBV: Participants will stand on the WBV device installed in their home for 10-minutes 5 days per week for 9 months, and attend Griffith University for a 30-minute high intensity resistance and impact training (HiRIT) session, supervised by a trained exercise physiologist or exercise scientist, twice per week for 9 months. Compliance is recorded by the device, and a participant diary will be completed every session.
Intervention code [1] 292426 0
Treatment: Devices
Intervention code [2] 292551 0
Lifestyle
Comparator / control treatment
Arm 1: CON: Participants will follow a very low-intensity, 30 min, unsupervised exercise program twice per week for 9 months.
Control group
Active

Outcomes
Primary outcome [1] 295666 0
Bone mineral density (BMD) of left femoral neck (FN) measured by dual-energy x-ray absorptiometry (DXA) in treatment (WBV) versus control.
Timepoint [1] 295666 0
1) Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month)
Primary outcome [2] 295667 0
Bone mineral density of left femoral neck measured by dual-energy x-ray absorptiometry (DXA) in treatment (WBV plus HiRIT) versus control (HiRIT alone) (Arm 2).
Timepoint [2] 295667 0
1) Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month)
Secondary outcome [1] 316159 0
Muscle function: pQCT-derived calf muscle mass and density in treatment (WBV) vs control groups.
Timepoint [1] 316159 0
1) Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month)
Secondary outcome [2] 316160 0
Muscle function: pQCT-derived calf muscle mass and density in treatment (WBV + HiRIT) vs control (HiRIT alone).
Timepoint [2] 316160 0
1) Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month)
Secondary outcome [3] 316161 0
Total number of falls (fractures) recorded in a daily diary over the 21 months of participation.
Timepoint [3] 316161 0
Daily diary.
Secondary outcome [4] 316162 0
Quality of Life, AQoL-6D to calculate QALYs
Timepoint [4] 316162 0
Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month) for AQoL, and daily for 21 months.
Secondary outcome [5] 316412 0
Health costs based on general practitioner (GP), emergency department (ED) visits, hospital admissions, procedures and diagnosis.

Health service use data will be obtained from Qld Health (for inpatient and outpatient procedures, costed using Diagnostic Related Groups - AR-DRGs v5.2). GP visits and community care will be obtained from study diaries. Incremental cost-effectiveness ratio's (ICERs) will be calculated by comparing intervention and control groups.
Timepoint [5] 316412 0
1) Post-intervention (9th month) 2) Post-Detraining (21st month)
Secondary outcome [6] 372026 0
Performance in timed up and go test
Timepoint [6] 372026 0
1) Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month)
Secondary outcome [7] 372027 0
Performance in functional reach test
Timepoint [7] 372027 0
1) Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month)
Secondary outcome [8] 372028 0
Performance in five times sit to stand test
Timepoint [8] 372028 0
1) Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month)
Secondary outcome [9] 372029 0
Performance in tandem walk test
Timepoint [9] 372029 0
1) Pre-intervention (Baseline) 2) Post-intervention (9th month) 3) Post-Detraining (21st month)

Eligibility
Key inclusion criteria
1) women
2) at least 5 year post-menopause
3) with low bone mineral density (hip BMD t score less than or equal to -1.0)
4) with or without anti-absorptive osteoporosis drug with no plans to change therapy for the next 21 months
5) willing and able to attend twice-weekly on-campus training and 5 times a week in-home WBV
6) weigh less than 125 kg
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Fraility
2) Inability to stand unaided
3) Cognitive impairment
4) Moderate to high levels of bone-relevant physical activity in previous 8 months
5) Regular use of vibration plate in last 8 months
6) Malignancy
6) On the following medications, Strontium ranelate or anabolic osteoporosis medication e.g. parathyroid hormone, corticosteroids, thyroxine, thiazide or anti-viral agents
7) Have conditions known to influence bone health e.g. thyrotoxicosis or hyperthyroidism, Paget's disease, renal diseases and diabetes, or to prevent engaging in HiRIT without risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Remote block randomisation will continue to be used to ensure RAs screening for inclusion are unaware of group allocation beforehand and that an equal number of participants are assigned to intervention and control groups. As previously, the randomisation sequence will be based on four possible group allocations (WVB, CON, WBV+HiRIT and HiRIT) and will be further stratified by presence of absence of osteoporosis medication. The sequence will be generated by the data management software, and be accessible online to study staff for individual participant allocation following baseline testing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analyses

At 12 months, separate analyses of the two primary hypotheses (with and without OP meds) will be performed. Femoral neck BMD loss is defined as [12 month femoral neck BMD] minus [0 month femoral neck BMD] = 0. To compare proportions of participants gaining or maintaining femoral neck BMD by treatment groups in both primary and secondary hypotheses, logistic regression models will be used, with adjustments for age, baseline values, BMI, physical activity, calcium consumption and serum 25(OH)D. The coefficient of variation of repeat measures of femoral neck BMD in our lab is 1.5% with a small root mean square error of 0.002 g/cm2. BMD measurement error will be appropriately addressed by adjusting the estimated odds ratios obtained from logistic regression models following standard statistical techniques71. Repeated measures comparisons of mean change in femoral neck BMD (gm/cm2) and secondary outcomes will also be conducted using univariate analyses, controlling for initial values, calcium, vitamin D and compliance. Separate analyses on adherence to medication will be conducted using treatment log diaries and information obtained during study visits and monthly meetings. The change in QoL scores over time will be compared between study groups using appropriate parametric and non-parametric techniques. Further exploratory analyses will include examination of secondary hypotheses and possible associations of anthropometric and compliance factors on the study outcomes. At 24 months, repeat analyses will be conducted to examine whether any treatment effect has been maintained.

In the absence of published data indicating the minimum percent improvement in the proportion of women losing bone over the course of a year required for public health benefit, we based our power calculations on a conservative estimate of 20%. Thus, from a two-sample difference of proportions test for 80% power with type 1 error of 5%, a sample size of 186 is required to detect hip BMD maintenance or gain in 50% of the WBV group (30%+20%). As a 2-year, home-based study could potentially experience greater attrition, we will over-recruit by 15% to power our exploratory analyses. Thus, to test primary hypothesis 1 in Arm 1, we will recruit 214 participants (186 + 28) and to test primary hypothesis 2 in Arm 2 we will also recruit 214 participants (186 + 28). Thus, to independently test both primary hypotheses, a total study n of 214 + 214 = 428 participants is required.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
31/08/2015
Actual
1/06/2018
Date of last participant enrolment
Anticipated
31/12/2020
Actual
5/05/2021
Date of last data collection
Anticipated
17/12/2023
Actual
Sample size
Target
428
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291738 0
Government body
Name [1] 291738 0
National Health and Medical Research Council (NHMRC)
Project Grant Scheme 2015 - 2018
Country [1] 291738 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Parklands Drive
Southport
QLD 4222
Country
Australia
Secondary sponsor category [1] 290412 0
None
Name [1] 290412 0
Address [1] 290412 0
Country [1] 290412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293260 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 293260 0
Ethics committee country [1] 293260 0
Australia
Date submitted for ethics approval [1] 293260 0
18/11/2014
Approval date [1] 293260 0
16/12/2014
Ethics approval number [1] 293260 0
AHS/61/14/HREC

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

Contacts
Principal investigator
Name 58906 0
Prof Belinda Beck
Address 58906 0
School of Health Sciences and Social Work, Gold Coast campus, Griffith University, Parklands Drive, Southport, QLD 4222
Country 58906 0
Australia
Phone 58906 0
+61 7 55528793
Fax 58906 0
+61 7 55528674
Email 58906 0
[email protected]
Contact person for public queries
Name 58907 0
Belinda Beck
Address 58907 0
School of Health Sciences and Social Work, Gold Coast campus, Griffith University, Parklands Drive, Southport, QLD 4222
Country 58907 0
Australia
Phone 58907 0
+61 7 55528793
Fax 58907 0
+61 7 55528674
Email 58907 0
[email protected]
Contact person for scientific queries
Name 58908 0
Belinda Beck
Address 58908 0
School of Health Sciences and Social Work, Gold Coast campus, Griffith University, Parklands Drive, Southport, QLD 4222
Country 58908 0
Australia
Phone 58908 0
+61 7 55528793
Fax 58908 0
+61 7 55528674
Email 58908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are not aware of how this can be achieved using clinical trial database management software which will be locked down at the completion of data collection.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2505Informed consent form  [email protected] 368962-(Uploaded-25-06-2019-13-41-43)-Study-related document.pdf
2506Ethical approval  [email protected] 368962-(Uploaded-25-06-2019-14-10-00)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of low-intensity whole-body vibration with or without high-intensity resistance and impact training on risk factors for proximal femur fragility fracture in postmenopausal women with low bone mass: study protocol for the VIBMOR randomized controlled trial.2022https://dx.doi.org/10.1186/s13063-021-05911-4
N.B. These documents automatically identified may not have been verified by the study sponsor.