Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000332820
Ethics application status
Approved
Date submitted
22/03/2012
Date registered
22/03/2012
Date last updated
22/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility Trial of Vibration Training in Frail Older People
Scientific title
Among older people admitted to inpatient rehabilitation wards does the use of whole body vibration lead to improvements in balance and a reduction in falls risk compared to usual care
Secondary ID [1] 280195 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls risk 286131 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286321 286321 0 0
Physiotherapy
Injuries and Accidents 286327 286327 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention group will involve whole body vibration as a component of usual care rehabilitation from entry into the rehabilitation wards to discharge (mean stay = 17 days). Usual care physiotherapy would occur in the morning and whole body vibration would be scheduled for the afternoon for patients randomised to whole body vibration. All Participants will receive usual inpatient physiotherapy care. whole body vibration will occur three times per week (with a minimum of 1-day rest in between) from onset of physiotherapy until discharge and consist of six static exercises targeting lower limb muscles. The frequency (load) of the vibrating platform will be at 30 to 50Hz and the amplitude will be progressively increased from 2 to 5 mm to allow the programme to be individually tailored to the participant and to ensure their heart rate remains below 85% age-predicted maximal heart rate. The intervention will begin wtih two sets of 30 seconds with a one minute rest in between repititions. The exercise volume and intensity will be progressively increased according to the overload-principle. Participants will stand on the whole body vibration platform in a semi-squat position and hold on to the railings secured onto the platform. This semi-squat position maximises the force of contact with the platform.
Intervention code [1] 284520 0
Rehabilitation
Intervention code [2] 284524 0
Prevention
Intervention code [3] 284525 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care physiotherapy sessions in the mornings from onset of physiotherapy until discharge.
Control group
Active

Outcomes
Primary outcome [1] 286792 0
The Physiological Profile Assessment is a valid and reliable tool for assessing fall risk in older people. Based on the performance of five physiological domains (vision, proprioception, strength, reaction time, and balance), the PPA computes a fall risk score.
Timepoint [1] 286792 0
Baseline and discharge from facility
Secondary outcome [1] 296664 0
Functional Independence Measure
Timepoint [1] 296664 0
Baseline and discharge from facility
Secondary outcome [2] 296665 0
Length of stay in the facility
Timepoint [2] 296665 0
at discharge from the facility
Secondary outcome [3] 296666 0
Health related quality of life (SF-12)
Timepoint [3] 296666 0
Baseline and discharge from facility

Eligibility
Key inclusion criteria
Individuals are potentially eligible if they meet all of the following criteria: (i) Aged 65 years or over; (ii) admitted to older persons rehabilitation ward under the care of a geriatrician; (iii) are able to stand from a chair with the aid of one person and; (iv) can provide written informed consent to participate in the study.
Minimum age
65 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinicians may consider a patient unsuitable to enrol if they have any of the following: (i) Severe cognitive impairment (MMSE <24/30) or otherwise judged unable to understand or comply with treatment protocol; (ii) Severe or unstable cardiovascular disease (i.e. unstable angina, pacemaker fitted, dysrhythmia other than controlled atrial fibrillation); (iii) Near-terminal disease (including advanced heart, lung, kidney, liver failure resistant to medical management); (iv) Acute Musculoskeletal Disorder.

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)
Patients admitted to an older persons rehabilitation ward willb e screened for inclusion in the study. Eligible patients will be approached to determine their willingness to participate in the trial. If they agree then they will be visited by a research assistant and informed consent will be obtained. Following this the will be randomised. Randomisation will be ascertained by a randomisation schedule held at a distant site. (50 in intervention group and 50 control). This schedule will be compiled by someone with no involvement in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was generated using a through numeric list randomly generated within Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4215 0
New Zealand
State/province [1] 4215 0

Funding & Sponsors
Funding source category [1] 284942 0
Government body
Name [1] 284942 0
Strategies to Advance Research, Tertiary Education Commission
Country [1] 284942 0
New Zealand
Primary sponsor type
Individual
Name
John Parsons
Address
The Applied Ageing Research Group
School of Nursing, The University of Auckland
Faculty of Medical and Health Sciences
Level 2, Building 505, 85 Park Road, Grafton, Auckland, 1142,
Country
New Zealand
Secondary sponsor category [1] 283816 0
None
Name [1] 283816 0
Address [1] 283816 0
Country [1] 283816 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286952 0
Northern X Regional Ethics Committee
Ethics committee address [1] 286952 0
Ethics committee country [1] 286952 0
New Zealand
Date submitted for ethics approval [1] 286952 0
Approval date [1] 286952 0
20/06/2011
Ethics approval number [1] 286952 0

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

Contacts
Principal investigator
Name 33962 0
Address 33962 0
Country 33962 0
Phone 33962 0
Fax 33962 0
Email 33962 0
Contact person for public queries
Name 17209 0
John Parsons
Address 17209 0
The Applied Ageing Research Group
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Level 2, Building 505, 85 Park Road, Grafton, Auckland, 1142,
Country 17209 0
New Zealand
Phone 17209 0
+ 64 (0) 9 923 3935
Fax 17209 0
+ 64 (0) 9 367 7158
Email 17209 0
[email protected]
Contact person for scientific queries
Name 8137 0
John Parsons
Address 8137 0
The Applied Ageing Research Group
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Level 2, Building 505, 85 Park Road, Grafton, Auckland, 1142,
Country 8137 0
New Zealand
Phone 8137 0
+ 64 (0) 9 923 3935
Fax 8137 0
+ 64 (0) 9 367 7158
Email 8137 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.