ANZCTR - Registration

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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

Muscle Weakness in older persons living in residential care facility

Accidental Falls in older persons living in residential care facility

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Injuries and Accidents

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]

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]

Mean Centre of Pressure and Limits of Stability Scores measured using a Force Platform

Timepoint [1]

Baseline and 2 weeks after end of Intervention

Primary outcome [2]

Mean Muscle Strength score using the Repeated Sit to Stand Test

Timepoint [2]

Baseline and 2 weeks after end of Intervention

Secondary outcome [1]

Number of Falls recorded using a Falls Calender

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6018

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue
Nedlands WA 6009

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

Hospital Avenue
Nedlands WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Hospital (SCGH) Group Human Research Ethics Committee (HREC)

Ethics committee address [1]

Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/04/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Antonio (Tony) Petta

Address

Sir Charles Gairdner Hospital
C Block
Hospital Avenue
Nedlands WA 6009

Country

Australia

Phone

+ 61 08 9346 3282

Fax

tony.petta@health.wa.gov.au

Contact person for scientific queries

Name

Antonio (Tony) Petta

Address

Sir Charles Gairdner Hospital
C Block
Hospital Avenue
Nedlands WA 6009

Country

Australia

Phone

+61 08 9346 3282

Fax

tony.petta@health.wa.gov.au

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.

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