Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000961741
Ethics application status
Approved
Date submitted
23/08/2013
Date registered
29/08/2013
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiological, psychological and functional changes with Whole Body Vibration Exercise in the Frail Elderly
Scientific title
Physiological, psychological and functional changes with Whole Body Vibration Exercise in the Frail Elderly
Secondary ID [1] 283073 0
Nil
Universal Trial Number (UTN)
U1111-1136-7146
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functionality & Falls-Prevention 289910 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290276 290276 0 0
Other physical medicine / rehabilitation
Musculoskeletal 290277 290277 0 0
Osteoporosis
Musculoskeletal 290278 290278 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Whole Body Vibration (WBV) exercise intervention group (WBV). Participants in this group will complete three 20-minute sessions of low-intensity WBV exercise each week for 24 weeks. Progression of Hz and amplitude will be dependent upon each individual’s ability to tolerate the low level vibration (individual comfort and body resonance), but the starting level for all participants will be 6Hz. The WBV exercise is performed with isometric knee flexion ~20 degrees (+/- 5 deg.) which provides a dampening effect to prevent spine or head vibration. The effects of WBV will be monitored using a small health questionnaire & perceived exertion scale - the results of which will be fed-back to geriatricians.
Arm 2: Simulated-WBV exercise intervention group (SIM). Participants in this group will complete three 20-minute exercise sessions each week for 24 weeks, in which they will mimic the standing on the machine (but with no vibration)
All sessions for groups 1 & 2 (WBV & SIM) will be supervised by University staff or trained students (all with 1st aid certification).
Arm 3: Control group (CON). No exercise intervention
All participants will continue to receive standard care.
Intervention code [1] 287787 0
Treatment: Devices
Comparator / control treatment
Participants in the Control group (CON) will continue to receive standard care, but will receive no exercise intervention.
Control group
Active

Outcomes
Primary outcome [1] 290301 0
Primary Outcome: Functionality/balance and falls-confidence, as assessed using the Timed-Up-and-Go and Parallel Walk Tests, complemented by the Barthel Index Questionnaire (and the Activities-specific Balance Confidence (ABC-UK) scale).
Timepoint [1] 290301 0
Timepoint: Baseline; at 8, 16 and 24 weeks after intervention commencement; and 0, 3, 6 and 12-months after completion of intervention.
Primary outcome [2] 290302 0
Primary Outcome: Quality of Life, assessed using the Euro-Qol EQ-5D-3L health questionnaire and the Activities-specific Balance Confidence (ABC-UK) scale.
Timepoint [2] 290302 0
Timepoint: Baseline; at 8, 16 and 24 weeks after intervention commencement; and 0, 3, 6 and 12-months after completion of intervention.
Secondary outcome [1] 304278 0
Secondary Outcome: Bone health, to be assessed using Peripheral Quantitative Computed Tomography (p-QCT) scans, in addition to biochemical markers of osteoblast and osteoclast activity.

Serum Osteocalcin will be measured to quantify osteoformation (osteoblast activity), whilst bone resorption (osteoclast activity) will be measured by urinary levels of pyridinoline and deoxypyridinoline. These biomarkers are established measures for monitoring of bone loss, bone reformation and the effectiveness of treatments. Furthermore, whole body calcium and vitamin D levels will also be assessed, levels of which are shown to be inversely linked to rates of fracture and osteoporotic bone loss.
Timepoint [1] 304278 0
Timepoint: Baseline, upon completion of intervention, and 12-months after completion.
Secondary outcome [2] 304279 0
Secondary Outcome: Changes in cardiovascular parameters such as cardiac output, peripheral resistance, blood pressure, heart rate, and left ventricular expulsion will be monitored throughout the study, using a FinaPress system.
Timepoint [2] 304279 0
Timepoint: Baseline; at 8, 16 and 24 weeks after intervention commencement; and 0, 3, 6 and 12-months after completion of intervention.

Eligibility
Key inclusion criteria
Institutionalized in a care home
Are frail individuals, as categorised by a Functional Ambulation Categorisation of 2-5
Asymptomatic for pain
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For all participants in the study:
Individuals engaging in above normal levels of exercise already
Knee or hip prosthesis
A recent history of venous thrombosis, fracture or surgery
Individuals with spinal tumours or metastases, disc herniation or aortic aneurisms
A cognitive ability score below 22 in the RUDAS assessment
Individuals with a pacemaker, Epilepsy, or Diabetes with peripheral neuropathy
Biochemical indicators of pathologies such as Paget’s disease, renal disease, FBC, or diabetes

For those undergoing bone-health measures only:
Individuals suffering from hypoparathyroidism or diseases/conditions resulting in hypercalcaemia and/or hypercalciuria
Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency

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)
Following consultation with Care Home staff & management, a presentation will be made to residents (including a demonstration of the WBV machine), and potential volunteers will be given information sheets. Approximately 1 week later, researchers will meet with interested volunteers, and commence pre-screening health measures. Upon collecting baseline measures, participants will be asked to choose between 3 cards (face-down) which will randomly allocate them to a group according to their selection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As above (random, blinded selection)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The above indices provide quantitative data for comparative analysis between groups and over time (pre- and post-intervention), which can be analysed by analysis of variance (ANOVA) and repeated-measures ANOVA for the different time points (t=0, 8, 16, 24 weeks of exercise and 3, 6 and 12 months post-intervention).

Sample size was calculated based on a study of WBV effects on balance in elderly women where the measure of balance is directional control (Cheung et al, 2007). Effect size was based on mean changes of 0.6. For the probability, we considered an alpha level of p=0.05 for a two tailed test, (type I to type II error ratio of 1:2 i.e. beta=2 x 0.05 i.e. 0.1), and a power of 1- beta, i.e. Power (for two-tailed alpha 0.05) = 0.9. Using the effect size curves of Thomas & Nelson (2001), the sample size required was calculated to be 252 participants (60 in each group + a 40% drop-out rate).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2013
Actual
15/08/2013
Date of last participant enrolment
Anticipated
5/01/2015
Actual
12/08/2016
Date of last data collection
Anticipated
Actual
20/12/2017
Sample size
Target
252
Accrual to date
Final
117
Recruitment outside Australia
Country [1] 5333 0
New Zealand
State/province [1] 5333 0
Wellington

Funding & Sponsors
Funding source category [1] 287834 0
University
Name [1] 287834 0
Massey University, New Zealand
Country [1] 287834 0
New Zealand
Funding source category [2] 287835 0
Government body
Name [2] 287835 0
Accident Compensation Corporation, New Zealand
Country [2] 287835 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University,
Private Bag 756
Wellington 6014
Country
New Zealand
Secondary sponsor category [1] 286560 0
None
Name [1] 286560 0
Address [1] 286560 0
Country [1] 286560 0
Other collaborator category [1] 277585 0
Individual
Name [1] 277585 0
Dr Janet Turnbull, Capital & Cost District Health Board
Address [1] 277585 0
Kenepuru Community Hospital
PO Box 50215
Kenepuru, Porirua City
Wellington
5022
Country [1] 277585 0
New Zealand
Other collaborator category [2] 277593 0
Individual
Name [2] 277593 0
Dr Kate Scott, Capital & Cost District Health Board
Address [2] 277593 0
Kenepuru Community Hospital
PO Box 50215
Kenepuru, Porirua City
Wellington
5022
Country [2] 277593 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289776 0
Health & Disability Ethics Committees
Ethics committee address [1] 289776 0
Ethics committee country [1] 289776 0
New Zealand
Date submitted for ethics approval [1] 289776 0
Approval date [1] 289776 0
15/04/2013
Ethics approval number [1] 289776 0
12/NTB/78

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

Contacts
Principal investigator
Name 42366 0
Mr Daniel Wadsworth
Address 42366 0
University of the Sunshine Coast
School of Nursing, Midwifery & Paramedicine
Locked Bag 4
MAROOCHYDORE DC QLD 4558
Country 42366 0
Australia
Phone 42366 0
+61 07 5430 2944
Fax 42366 0
n.a
Email 42366 0
[email protected]
Contact person for public queries
Name 42367 0
Daniel Wadsworth
Address 42367 0
University of the Sunshine Coast
School of Nursing, Midwifery & Paramedicine
Locked Bag 4
MAROOCHYDORE DC QLD 4558
Country 42367 0
Australia
Phone 42367 0
+61 07 5430 2944
Fax 42367 0
n/a
Email 42367 0
[email protected]
Contact person for scientific queries
Name 42368 0
Sally Lark
Address 42368 0
Massey University,
Private Bag 756,
Wellington, 6012.
Country 42368 0
New Zealand
Phone 42368 0
+64 4 801 5799 (ext. 62503)
Fax 42368 0
+64 4 801 4994
Email 42368 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2237Study protocol    https://www.sciencedirect.com/science/article/pii/... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Whole-Body Vibration Training on the Physical Function of the Frail Elderly: An Open, Randomized Controlled Trial.2020https://dx.doi.org/10.1016/j.apmr.2020.02.009
EmbasePsychological Effects of Whole-Body Vibration Training in Frail Older Adults: An Open, Randomized Control Trial.2022https://dx.doi.org/10.1123/japa.2020-0400
N.B. These documents automatically identified may not have been verified by the study sponsor.