Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000029594
Ethics application status
Approved
Date submitted
19/01/2006
Date registered
20/01/2006
Date last updated
16/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A consumer-adoption study: Exercise training for the healthy elderly
Scientific title
A consumer-adoption study: A randomized controlled trial of exercise training for older adults in an Australian retirement community setting to improve physical function and health-related quality of life.
Universal Trial Number (UTN)
Trial acronym
BEST : Balance, Endurance, and Strength Training
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy elderly population 992 0
Condition category
Condition code
Public Health 1067 1067 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 10 week multi-modal , supervised exercise program (balance, endurance, and high intensity progressive resistance training).
Intervention code [1] 827 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1428 0
Strength
Timepoint [1] 1428 0
Measured at baseline and after either a 10 week intervention or no intervention control.
Primary outcome [2] 1429 0
Balance
Timepoint [2] 1429 0
Measured at baseline and after either a 10 week intervention or no intervention control.
Primary outcome [3] 1430 0
Performance-based function
Timepoint [3] 1430 0
Measured at baseline and after either a 10 week intervention or no intervention control.
Secondary outcome [1] 2522 0
Health-related quality of life.
Timepoint [1] 2522 0
Measured at baseline and after either a 10 week intervention or no intervention control.
Secondary outcome [2] 2523 0
Depressive symptoms.
Timepoint [2] 2523 0
Measured at baseline and after either a 10 week intervention or no intervention control.
Secondary outcome [3] 2524 0
Self-efficacy.
Timepoint [3] 2524 0
Measured at baseline and after either a 10 week intervention or no intervention control.
Secondary outcome [4] 2525 0
Behavioural outcomes.
Timepoint [4] 2525 0
Measured at baseline and after either a 10 week intervention or no intervention control.
Secondary outcome [5] 2526 0
Customer intentions (intention to stay, intention to recommend).
Timepoint [5] 2526 0
Measured at baseline and after either a 10 week intervention or no intervention control.

Eligibility
Key inclusion criteria
Residents of retirement village.
Minimum age
60 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of limiting chronic illness.

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)
Randomization lists of intervention and control groups were generated and maintained by an investigator not involved in recruiting, testing or training subjects and allocations were emailed to the study coordinator after all baseline testing was completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized random number generator available at www.randomization.com (Program written by Gerard Dallal, PhD)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1166 0
University
Name [1] 1166 0
ARC-Linkage Projects Grant
Country [1] 1166 0
Australia
Funding source category [2] 1167 0
Commercial sector/Industry
Name [2] 1167 0
Primelife Corporation Limited
Country [2] 1167 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 1027 0
University
Name [1] 1027 0
University of Sydney
Address [1] 1027 0
Country [1] 1027 0
Australia
Secondary sponsor category [2] 1028 0
University
Name [2] 1028 0
University of Arkansas
Address [2] 1028 0
Country [2] 1028 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2484 0
University of NSW HREC
Ethics committee address [1] 2484 0
Ethics committee country [1] 2484 0
Australia
Date submitted for ethics approval [1] 2484 0
Approval date [1] 2484 0
Ethics approval number [1] 2484 0
Ethics committee name [2] 2485 0
University of Sydney HREC
Ethics committee address [2] 2485 0
Ethics committee country [2] 2485 0
Australia
Date submitted for ethics approval [2] 2485 0
Approval date [2] 2485 0
Ethics approval number [2] 2485 0

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

Contacts
Principal investigator
Name 36259 0
Address 36259 0
Country 36259 0
Phone 36259 0
Fax 36259 0
Email 36259 0
Contact person for public queries
Name 10016 0
Professor Maria Fiatarone Singh
Address 10016 0
School of Exercise and Sport Science
Faculty of Health Sciences
University of Sydney
East Street
Lidcombe NSW 2141
Country 10016 0
Australia
Phone 10016 0
+61 2 93519755
Fax 10016 0
Email 10016 0
m.singh@fhs.usyd.edu.au
Contact person for scientific queries
Name 944 0
Professor Maria Fiatarone Singh
Address 944 0
School of Exercise and Sport Science
Faculty of Health Sciences
University of Sydney
East Street
Lidcombe NSW 2141
Country 944 0
Australia
Phone 944 0
+61 2 93519755
Fax 944 0
Email 944 0
m.singh@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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.