ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000431325

Ethics application status

Approved

Date submitted

19/08/2008

Date registered

29/08/2008

Date last updated

29/08/2008

Type of registration

Retrospectively registered

Titles & IDs

Public title

Innovative strategies to assist falling elderly - ISAFE

Scientific title

Innovative Strategies to Assist Falling Elderly – ISAFE: a program initiative for falls and injury prevention in the community

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Fall prevention

Falls risk reduction

Condition category

Condition code

Public Health

Health promotion/education

Public Health

Other public health

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Specific Balance Strategy Exercise Program. Subjects in the intervention group will attend a one hour twice-weekly specific balance-strategy training program for 12 weeks. The program will be delivered using work-stations that target the multiple elements of balance that are integral to efficient balance and mobility. Content of this program will include functional strength training and flexibility exercises that load trunk and lower limb muscles in all planes of movement, exercises for postural control and tasks that challenge medio-lateral stability and work participants at the limits of their stability; tasks that foster the use of ankle, hip, stepping and suspension strategies along with speed and efficient reaction times will be used. The program and tasks will be progressed by adding surface and visual challenges and by adding dual / multiple tasks

Intervention code [1]

Prevention

Intervention code [2]

Early detection / Screening

Intervention code [3]

Treatment: Other

Comparator / control treatment

there is no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Falls risks Assessment: Falls Management and Prevention Program (MAPP) Referral checklist

Timepoint [1]

at baseline only

Primary outcome [2]

measure of extended activities of daily living:Frenchay Activities Index

Timepoint [2]

at baseline and 12 weeks after intervention

Primary outcome [3]

number of falls

Timepoint [3]

at baseline only

Secondary outcome [1]

balance and mobility measures: The measures used were Balance and Mobility Measures (Boomer) including Timed static stance, Functional reach with right and left arm, Step test with right and left foot and Timed up and go (TUG) test. Clinical measures include functional reach (Duncan et al, 1990) measures reaching forward to the limits of stability from a bilateral stance position;the functional step test with right and left foot (Hill et al 1996) measures speed of performing a dynamic standing task with the number of repeated steps on and of a block 7.5 cm in height, in 15 seconds recorded; timed up and go (TUG) test (Shumway-Cook et al, 2000) measures the time taken to stand up from a chair, walk three metres as quickly and safely as possible past a line on the floor, turn around, walk back to the chair and sit down with the back against the chair;

Timepoint [1]

at baseline, 12 weeks after intervention

Secondary outcome [2]

cardiovascular endurance measures using 2 minute walk test

Timepoint [2]

at baseline, 12 weeks after intervention

Eligibility

Key inclusion criteria

living in a retirement village, independent living unit or hostel, or in their own home and attending a senior citizens centre, respite centre, day therapy or other supported programs for the older person capable of participating safely in a group exercise program

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

where medical assessment precludes safe participation in the activity program. This will be identified through the Falls Referral checklist administered as part of the initial physiotherapy assessment.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised 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

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/05/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

4000-4999

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Commonwealth Government of Australia Population health division MDP15 GPO box 9848 Canberra ACT 2601

Address [1]

Department of Health and Ageing, Commonwealth Government of Australia Population health division MDP15 GPO box 9848 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Government body

Name

‘Falls and injury prevention community grants programs’, Department of Health and Ageing, Commonwealth Government of Australia

Address

Department of Health and Ageing, Commonwealth Government of Australia Population health division MDP15 GPO box 9848 Canberra ACT 2601

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Domiciliary Allied health Acute and Rehabilitation Team (DAART) Mater Health Services

Address [1]

DAART Ground Floor
Mater health Services
39 Annerley Road
Woolloongabba QLD 4102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Health Services Human Research Ethics Committee

Ethics committee address [1]

Room235 Aubigny Place 
Mater Health Services
Raymond Tce 
South Brisbane, QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/05/2007

Ethics approval number [1]

1091A

Summary

Brief summary

The aim of this project was to reduce falls risk in people 65 years and older living in the community in retirement villages, independent living units and hostels or in their own homes and attending a respite centre, day therapy or other supported program for older people, eg. Senior Citizens’ Centres. The geographical area involved was the Brisbane metropolitan region including bayside. The process involved implementation and evaluation of a sustainable model of service delivery based on best practice falls prevention interventions, including individualized risk assessment and a specific targeted intervention. 

The objectives of the Project were to:
encourage best practice falls prevention interventions in the community;
increase access to falls prevention information, strategies, and activities for community dwelling older persons and the multidisciplinary team including the GP;
build partnerships to reduce falls in older people within selected facilities and for the target population in metropolitan Brisbane and environs; and
recommend a sustainable model of service delivery taking into consideration the emerging workforce issues in the future.

The strategies employed to deliver the objectives were to
increase participation in the target population by offering group exercise programs to 500 participants in the Brisbane metropolitan (including bayside) area;ensure the program is targeted to the risk factors of the individual participants by a screening process followed by referral for appropriate assessment and management;
measure the impact of the risk reduction interventions;
ensure a coordinated approach by all involved in the project;
build capacity in community service providers to consistently assess and manage people at risk of falling; and
develop and describe a sustainable model of activity promotion, implementation and evaluation for this target population.

The outcomes from this intervention study may provide information to address the development of future programs to reduce the risk of falls in people over 65 years of age.  The project will identify and describe the nature and level of risk factors of falls in the target population and will assist program planners to determine the appropriate workforce combination required for the program to continue.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Stephanie Fu

Address

DAART Ground floor
Mater Health Services
39 Annerley Road
Woolloongabba QLD 4102

Country

Australia

Phone

+ 61 7 3163 1765

Fax

s.fu@uq.edu.au

Contact person for scientific queries

Name

Stephanie Fu

Address

Division of Physiotherapy
School of health and rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+ 61 7 33652779

Fax

s.fu@uq.edu.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.

Trial Review

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