Trial Review

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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] 690 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall prevention 3577 0
Falls risk reduction 3578 0
Condition category
Condition code
Public Health 3736 3736 0 0
Health promotion/education
Public Health 3737 3737 0 0
Other public health
Physical Medicine / Rehabilitation 3738 3738 0 0
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] 3292 0
Prevention
Intervention code [2] 3293 0
Early detection / Screening
Intervention code [3] 3294 0
Treatment: Other
Comparator / control treatment
there is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4636 0
Falls risks Assessment: Falls Management and Prevention Program (MAPP) Referral checklist
Timepoint [1] 4636 0
at baseline only
Primary outcome [2] 4637 0
measure of extended activities of daily living:Frenchay Activities Index
Timepoint [2] 4637 0
at baseline and 12 weeks after intervention
Primary outcome [3] 4638 0
number of falls
Timepoint [3] 4638 0
at baseline only
Secondary outcome [1] 7832 0
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] 7832 0
at baseline, 12 weeks after intervention
Secondary outcome [2] 7833 0
cardiovascular endurance measures using 2 minute walk test
Timepoint [2] 7833 0
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] 1118 0
4000-4999

Funding & Sponsors
Funding source category [1] 3753 0
Government body
Name [1] 3753 0
Commonwealth Government of Australia Population health division MDP15 GPO box 9848 Canberra ACT 2601
Country [1] 3753 0
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] 3366 0
Hospital
Name [1] 3366 0
Domiciliary Allied health Acute and Rehabilitation Team (DAART) Mater Health Services
Address [1] 3366 0
DAART Ground Floor
Mater health Services
39 Annerley Road
Woolloongabba QLD 4102
Country [1] 3366 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5811 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 5811 0
Ethics committee country [1] 5811 0
Australia
Date submitted for ethics approval [1] 5811 0
Approval date [1] 5811 0
03/05/2007
Ethics approval number [1] 5811 0
1091A

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

Contacts
Principal investigator
Name 28860 0
Address 28860 0
Country 28860 0
Phone 28860 0
Fax 28860 0
Email 28860 0
Contact person for public queries
Name 12017 0
Stephanie Fu
Address 12017 0
DAART Ground floor
Mater Health Services
39 Annerley Road
Woolloongabba QLD 4102
Country 12017 0
Australia
Phone 12017 0
+ 61 7 3163 1765
Fax 12017 0
Email 12017 0
[email protected]
Contact person for scientific queries
Name 2945 0
Stephanie Fu
Address 2945 0
Division of Physiotherapy
School of health and rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072
Country 2945 0
Australia
Phone 2945 0
+ 61 7 33652779
Fax 2945 0
Email 2945 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.