Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000025538
Ethics application status
Approved
Date submitted
18/01/2006
Date registered
20/01/2006
Date last updated
20/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle Integrated approach to reduce Falls through Exercise (LIFE)
Scientific title
Lifestyle (LIFE) versus structured balance and strength training to reduce falls in the elderly: a randomized trial
Universal Trial Number (UTN)
Trial acronym
LIFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falling in elderly 986 0
Condition category
Condition code
Public Health 1061 1061 0 0
Health promotion/education
Injuries and Accidents 1062 1062 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One arm will receive a lifestyle approach to exercise whereby balance and lower limb strenghtening activities are embedded in daily life activity. This will be taught as a weekly home based exercise program over 8 to 10 weeks with a 3 and 6 month follow up. A second arm will investigate a structured balance and strength training home based program. This will be taught with up to 8 weekly visits and a 3 and 6 month follow up visit. The third arm will teach a flexibility program. This will be taught at home over one visit. All three exercise programs will have additional telephone contact.
Intervention code [1] 846 0
Prevention
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1423 0
Occurrence of falls in high risk people over a one-year period
Timepoint [1] 1423 0
Recorded each day on a monthly self-report falls surveillance calendar over a one-year period
Secondary outcome [1] 2508 0
Static and dynamic balance
Timepoint [1] 2508 0
Measured at baseline, 6 months and 12 months.
Secondary outcome [2] 2509 0
Gait instability
Timepoint [2] 2509 0
Measured at baseline, 6 months and 12 months.
Secondary outcome [3] 2510 0
Lower limb strengh: hip abduction, knee extension and ankle dorsi flexion
Timepoint [3] 2510 0
Measured at baseline, 6 months and 12 months.
Secondary outcome [4] 2511 0
Falls and balance self efficacy
Timepoint [4] 2511 0
Measured at baseline, 6 months and 12 months.
Secondary outcome [5] 2512 0
Habitual physical activity and sedentary behavour
Timepoint [5] 2512 0
Measured at baseline, 6 months and 12 months.
Secondary outcome [6] 2513 0
Body composition: Fat-free muscle mass and fat mass and distribution.
Timepoint [6] 2513 0
Measured at baseline, 6 months and 12 months.
Secondary outcome [7] 2514 0
Health related quality of life
Timepoint [7] 2514 0
At baseline and 12 months.
Secondary outcome [8] 2515 0
Functional independence
Timepoint [8] 2515 0
At baseline and 12 months.
Secondary outcome [9] 2516 0
Predictors of adherence
Timepoint [9] 2516 0
At baseline and 12 months.

Eligibility
Key inclusion criteria
Had two falls or one injurious fall in the past year.
Minimum age
70 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Resident in a nursing home or hostel2. Two or more errors on the Short Portable Mental Status Questionnaire 3. Do not have conversational english 4. Not able to ambulate independently 5. Use a wheelchair or walking frame outdoors.6. Have an unstable or terminal medical illness which would preclude the planned exercises and is unlikely to resolve 7. Have a neurological condition that results in motor performance difficulties such as Parkinson’s Disease or hemiplegia from stroke.8. On oxygen regularly during waking hours.

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)
Allocation will occur after baseline assessment by the research therapist who is not involved with follow up assessments. They will log onto a secure password protected, study-specific web site. They will enter age, gender and history of falls and the subject will be randomised into one of the three arms according to a pre-defined schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By random block groups of 3 and 6, and stratified by gender and history of fall (that is, one or two falls OR 3 or more falls)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Three arm randomized trial. Two interventions and one placebo.
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
381
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1162 0
Government body
Name [1] 1162 0
NHMRC project grant
Country [1] 1162 0
Australia
Primary sponsor type
University
Name
The Univeristy of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1023 0
Government body
Name [1] 1023 0
Department of Veterans Affairs
Address [1] 1023 0
Country [1] 1023 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2479 0
The University of Sydney, Department of Veterans Affairs
Ethics committee address [1] 2479 0
Ethics committee country [1] 2479 0
Australia
Date submitted for ethics approval [1] 2479 0
Approval date [1] 2479 0
Ethics approval number [1] 2479 0

Summary
Brief summary
The aim of this project is to improve the capacity of people living at home to avoid falls. The project will evaluate the effectiveness of an integrated lifestyle apporach to balance and strength exercise (LIFE) and a structured balance and strenght exercise program to reducing falls in people who are at high risk. In the lifestyle approach (LIFE), older people will be taught how to do balance and strenght training and integrate it into their lifestyle so that its is embedded within their daily activity and weekly routines. It is expected that this integrated lifesytle apporach to balance and strenght training will be effective in reducing falls and will be sustainable over a one-year period. This study will also determine for which groups of peoploe LIFE is most effective. The trial is a 3-arm randomized trial that will be conducted with 381 pepople who are 70 years or over, who have experienced at least two falls in the past year or had an injurious fall.
the notion of balance trianing is not well understood. A product of this project will be an alternative balance ans strength intervention (LIFE) that offers, in a user friendly and simplified manner, a way of operationalizing the principles of balance and strength training for use by older people within their daily lives.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36070 0
Address 36070 0
Country 36070 0
Phone 36070 0
Fax 36070 0
Email 36070 0
Contact person for public queries
Name 10035 0
Ms. Kate Manollaris
Address 10035 0
School of Occupation & Leisure Sciences
Faculty of Health Sciences
PO Box 170
Lidcombe NSW 1825
Country 10035 0
Australia
Phone 10035 0
+61 2 93519994
Fax 10035 0
Email 10035 0
[email protected]
Contact person for scientific queries
Name 963 0
Dr. Lindy Clemson
Address 963 0
Faculty of Health Sciences
PO Box 170
Lidcombe NSW 1825
Country 963 0
Australia
Phone 963 0
+61 2 97191412
Fax 963 0
Email 963 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.