Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000201279
Ethics application status
Approved
Date submitted
16/04/2009
Date registered
21/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Whole Body Vibration on balance, muscle strength and falls in older persons living in residential care
Scientific title
Does Whole Body Vibration exercise improve balance and muscle strength and reduce the number of falls in older persons living in residential care
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance Impairment in older persons living in residential care facility 4614 0
Muscle Weakness in older persons living in residential care facility 4615 0
Accidental Falls in older persons living in residential care facility 4616 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4914 4914 0 0
Physiotherapy
Injuries and Accidents 4915 4915 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whole Body Vibration (WBV) Exercise. In addition to group based balance and strength exercise (See Control Treatment) participants in the intervention group will also perform an additional 3 sessions of WBV exercise per week for 8 consecutive weeks ending at week 8. Participants will perform a minimum of 1 minute of WBV exercise per session (Week 1) progressing to a maximum of 5 x 1 minute repetitions in one WBV session (Week 8). Each 1-minute repetition will be followed by a 1-minute rest period. WBV exercise will be devlivered by a commercially available WBV Machine which consists of an oscillating platform (see - saw mechanism) of adjustable frequency and amplitude. The frequency of WBV exercise for the 1st, 3rd and 5th minute will be set at 18Hz. During the 2nd and 4th minutes the frequency will be set at 6Hz. Amplitude of the side-to-side motion of the platform will remain constant at 7 mm total (3.5 mm each side).
Intervention code [1] 4377 0
Treatment: Devices
Comparator / control treatment
Active Control. Group based strength and balance exercise program. This will be delivered twice a week over a 8 week period with each session lasting 30 minutes. The exercises will be administered by a experienced Physiotherapy Assistant under the guidance and supervision of a physiotherapist according to standard work practises at the facility. The exercises will be chosen according to the balance and strength capcity of the participants identified during baseline assessment. Exercises will be targeted to identified lower limb muscle groups known to be implicated in accidental falls. A selction of static and dynamic balance exercises will also be used to challenge balance systems.
Control group
Active

Outcomes
Primary outcome [1] 5760 0
Mean Centre of Pressure and Limits of Stability Scores measured using a Force Platform
Timepoint [1] 5760 0
Baseline and 2 weeks after end of Intervention
Primary outcome [2] 5761 0
Mean Muscle Strength score using the Repeated Sit to Stand Test
Timepoint [2] 5761 0
Baseline and 2 weeks after end of Intervention
Secondary outcome [1] 241714 0
Number of Falls recorded using a Falls Calender
Timepoint [1] 241714 0
Baseline and monthly for 6 months after the end of Intervention

Eligibility
Key inclusion criteria
-Male or Female at least 65 years of age.
-Living in the defined Residential Aged Care Facility – Independent Living Units -Able to stand independently with or without aids.
-Cognitive capacity sufficient to understand the requirements of Whole Body Vibration and or group based strength and balance exercise.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Cognitive impairment such that they are unable to understand the requirements of WBV exercise.
- Unable to stand independently without at most a walking aid for support.
- Lower Limb Joint Arthroplasty.
- Acute Inflammatory arthritis.
- Acute Neurological or Cardiac Event.
- Current acute soft tissue injury in the lower limbs, Lumbar or Thoracic Spine.
- Acute (un-united) fracture of the lower limbs, Lumbar or Thoracic Spine.
- History of Deep Venous Thrombosis.
- Current participation in a resistance-training program.
- Known Gallstones, kidney or bladder stones
- Peripheral Vascular Disease

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1593 0
6018

Funding & Sponsors
Funding source category [1] 4797 0
Hospital
Name [1] 4797 0
Sir Charles Gairdner Hospital
Country [1] 4797 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 4349 0
None
Name [1] 4349 0
Address [1] 4349 0
Country [1] 4349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6845 0
Sir Charles Gairdner Hospital (SCGH) Group Human Research Ethics Committee (HREC)
Ethics committee address [1] 6845 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 6845 0
Australia
Date submitted for ethics approval [1] 6845 0
Approval date [1] 6845 0
16/04/2009
Ethics approval number [1] 6845 0
2009-020

Summary
Brief summary
Falls and falls-related injuries are a serious public health issue affecting people aged 65 years and over. It is estimated that 1 in 3 people over the age of 65 will fall every year. Falls are the leading cause of injury-related hospitalization and death in persons older than 65 years of age. They are often the key precipitating factor in leading to admission to an residential aged care (RAC) facility. People living in RAC have a higher rate of falls than older people living in the community. They are generally frailer with greater muscle weakness than their peers living independently at home.

There are usually a number of causes of falls. Risk factors that contribute to falls include gait and balance disorders, visual problems, cognitive impairment, and the use of certain medications. Improving lower limb muscle strength and balance using exercise is an effective treatment in falls prevention. In the presence of osteoporosis, the incidence of fracture following a fall increases sharply. Once a person has sustained a fracture due to osteoporosis they are four times more likely to sustain another fracture in the proceeding 12 months than the non-fracture population.

Recent interest has emerged on the use of Mechanical Whole Body Vibration (WBV) as a potential therapy that may produce improvements in muscle strength, bone mineral density and balance. WBV works by stimulating the stretch reflex causing a contract - relax cycle of muscle. Given the benefits that WBV has been shown to provide to muscle strength, balance and bone mineral density it has the potential to play an important role in falls prevention particularly in frail older people who have difficulty participating in an active exercise program. It has been suggested that 5 minutes of WBV provides benefits equating with 30 minutes of traditional exercise. This may more achievable in the older person.

This study aims to assess the effects of WBV on the muscle strength, balance and falls of older residents living in a RAC facility. Participants who meet the criteria to participate in the study will have their balance and muscle strength assessed prior to commencing the study. Previous falls history will be recorded. All participants will perform a targeted group exercise program aimed at improving lower limb strength and balance. The exercise program will be run two times per week for 8 weeks with each session lasting approximately 30 minutes. Half of the participants will perform additional WBV exercise 3 times per week for 8 weeks under the supervision of a qualified physiotherapist who is experienced in the use of WBV exercise. Each WBV exercise session will be a maximum 10 minutes. At the end of the 8 weeks participants will have their muscle strength and balance reassessed. Information on Falls will be collected for a further 6 months.
Trial website
No trial website is available.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29499 0
Address 29499 0
Country 29499 0
Phone 29499 0
Fax 29499 0
Email 29499 0
Contact person for public queries
Name 12746 0
Antonio (Tony) Petta
Address 12746 0
Sir Charles Gairdner Hospital
C Block
Hospital Avenue
Nedlands WA 6009
Country 12746 0
Australia
Phone 12746 0
+ 61 08 9346 3282
Fax 12746 0
Email 12746 0
[email protected]
Contact person for scientific queries
Name 3674 0
Antonio (Tony) Petta
Address 3674 0
Sir Charles Gairdner Hospital
C Block
Hospital Avenue
Nedlands WA 6009
Country 3674 0
Australia
Phone 3674 0
+61 08 9346 3282
Fax 3674 0
Email 3674 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.