Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000013561
Ethics application status
Approved
Date submitted
22/12/2005
Date registered
9/01/2006
Date last updated
16/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of the LIFE Lifestyle approach to balance and strength training in improving balance and strength in older people: A randomized trial
Scientific title
The efficacy of the LIFE Lifestyle approach to balance and strength training in improving balance and strength in older people: A randomized trial
Secondary ID [1] 230 0
Fiatarone Singh, M., Bundy, A & Cumming, R. G.
Universal Trial Number (UTN)
Trial acronym
LIFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls prevention 974 0
Condition category
Condition code
Public Health 1048 1048 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Embedding balance and strength training within daily habitual routines. The intervention will be taught during weekly home visits for up to 8 weeks with a three month follow up. The participants will be assessed at baseline, 3 months and 6 months.
Intervention code [1] 814 0
Prevention
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1402 0
Improvement in balance
Timepoint [1] 1402 0
Assessed at baseline, 3 months and 6 months.
Primary outcome [2] 1403 0
Improvement in lower limb strength
Timepoint [2] 1403 0
Assessed at baseline, 3 months and 6 months.
Secondary outcome [1] 2475 0
Falls and exercise self efficacy
Timepoint [1] 2475 0
Secondary outcome [2] 2476 0
Physical Activity
Timepoint [2] 2476 0
Secondary outcome [3] 2477 0
Percieved health status
Timepoint [3] 2477 0
Secondary outcome [4] 2478 0
Life space assessment
Timepoint [4] 2478 0

Eligibility
Key inclusion criteria
Two falls in past year or one injurious fall.
Minimum age
70 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mod-severe cognitive impairment, no conversational english, inability to ambulate independently , resident in a nursing home or hostel, any unstable or terminal medical illness which would preclude the planned exercises, neurological conditions that result in motor performance difficulties such as hmeiplegia from stroke or parkinsons dissease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes. Allocation is by a researcher not involved in subject screening or subject assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization using a computer generated random numbers table, stratified in blocks, according to gender and number of falls in previous 12 months.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1146 0
University
Name [1] 1146 0
University of Sydney Bridging Grant
Country [1] 1146 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1003 0
None
Name [1] 1003 0
Nil
Address [1] 1003 0
Country [1] 1003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2470 0
The University of Sydney, Department of Veterans Affairs
Ethics committee address [1] 2470 0
Ethics committee country [1] 2470 0
Australia
Date submitted for ethics approval [1] 2470 0
Approval date [1] 2470 0
Ethics approval number [1] 2470 0

Summary
Brief summary
The LIFE program is an innovative way of embedding balance and strength training within daily life activity and it is designed to prevent falls. This pilot study is recruiting at-risk community residing elderly from metropolitan Sydney to a randomized trial to evaluate the efficacy of the program in improving and maintaining balance and lower limb strength. Subjects will be followed for a 6 month period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36365 0
Address 36365 0
Country 36365 0
Phone 36365 0
Fax 36365 0
Email 36365 0
Contact person for public queries
Name 10003 0
Ms Kate Manollaras
Address 10003 0
School of Occupation and Leisure Sciences
Faculty of Health Sciences
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 10003 0
Australia
Phone 10003 0
+61 2 93519833
Fax 10003 0
+61 2 93519166
Email 10003 0
k.manollaras@fhs.usyd.edu.au
Contact person for scientific queries
Name 931 0
Dr. Lindy Clemson
Address 931 0
School of Occupation and Leisure Sciences
Faculty of Health Sciences
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 931 0
Australia
Phone 931 0
+61 2 93519372
Fax 931 0
+61 2 93519166
Email 931 0
L.Clemson@fhs.usyd.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
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Documents added automatically
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