Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000122459
Ethics application status
Approved
Date submitted
22/01/2007
Date registered
12/02/2007
Date last updated
12/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A balance training exercise program for community-dwelling rural older people: A randomised controlled trial to assess feasibility and effect on falls risk
Scientific title
A balance training exercise program for community-dwelling rural older people: A randomised controlled trial to assess feasibility and effect on falls risk
Universal Trial Number (UTN)
Trial acronym
The Fit and Free Research Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls in community dwelling rural older people. 1614 0
Condition category
Condition code
Injuries and Accidents 1722 1722 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be asked to attend one exercise class per week (60 minute session) and perform an ancillary home exercise program over a fourteen week period. Participants in both the intervention and control group will receive an education booklet on falls prevention strategies.
Intervention code [1] 1569 0
Rehabilitation
Comparator / control treatment
Participants in control group will receive an education booklet on falls prevention strategies.
Control group
Active

Outcomes
Primary outcome [1] 2390 0
Falls Risk Factors
Timepoint [1] 2390 0
Assessed prior to intervention and 14 weeks after intervention commencement.
Secondary outcome [1] 4156 0
Quality of life measures
Timepoint [1] 4156 0
Assessed prior to intervention and 14 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Living independently in the community or in residential care accommodation.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment: a moderate to severe organic brain impairment Insufficient English language: to participate safely in the exercise program. Unable to walk 10 metres: without rest or help (walking aid permitted) Progressive neurological disease (eg Parkinson’s disease), Medical condition precluding exercise e.g. unstable ischaemic heart disease, recent electrocardiographic changes or cardiac event, uncontrolled cardiac arrhythmia eg Ventricular tachycardia (VT) requiring implantable defibrillator or unpaced complete heart block, NYHA class 3 and 4 symptomatic heart failure, or use of a ventricular assist device, severe valvular heart disease assessed clinically by medical staff, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aortic aneurysm.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation schedule prepared by a researcher not involved in recruitment. Group allocation kept in sealed opaque envelopes which were opened after baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated with random number function in excel with blocks of undisclosed size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1869 0
Charities/Societies/Foundations
Name [1] 1869 0
The Physiotherapy Research Foundation
Country [1] 1869 0
Funding source category [2] 1870 0
University
Name [2] 1870 0
The University of Newcastle
Country [2] 1870 0
Australia
Funding source category [3] 1871 0
Government body
Name [3] 1871 0
The Commonwealth Department of Health and Aging
Country [3] 1871 0
Australia
Primary sponsor type
University
Name
The Faculty of Health Sciences, The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 1686 0
Government body
Name [1] 1686 0
Hunter New England Area Health Service
Address [1] 1686 0
Country [1] 1686 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3478 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 3478 0
Ethics committee country [1] 3478 0
Australia
Date submitted for ethics approval [1] 3478 0
Approval date [1] 3478 0
25/11/2005
Ethics approval number [1] 3478 0
DB217
Ethics committee name [2] 3479 0
Newcastle University Human Research Ethics Committee
Ethics committee address [2] 3479 0
Ethics committee country [2] 3479 0
Australia
Date submitted for ethics approval [2] 3479 0
Approval date [2] 3479 0
20/07/2005
Ethics approval number [2] 3479 0
H- 070-0705

Summary
Brief summary
A randomised control trial will be conducted to determine whether participation in a supervised weekly group exercise program with ancillary home exercises reduces falls risk in elderly persons living in rural communities. The risk factors to be investigated include balance, muscle strength and reaction time. Quality of life and health status will also be compared between the groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27503 0
Address 27503 0
Country 27503 0
Phone 27503 0
Fax 27503 0
Email 27503 0
Contact person for public queries
Name 10758 0
Ms Karyn Blackman
Address 10758 0
The University Department of Rural Health
Locked Bag 9783
NEMSC
Tamworth NSW 2348
Country 10758 0
Australia
Phone 10758 0
+61 2 67678479
Fax 10758 0
+61 2 67612355
Email 10758 0
Karyn.Blackman@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 1686 0
Associate Professor Darren Rivett
Address 1686 0
The Discipline of Physiotherapy
Faculty of Health Sciences
The University of Newcastle
Box 24 Hunter Building
Callaghan NSW 2308
Country 1686 0
Australia
Phone 1686 0
+61 2 49217821
Fax 1686 0
+61 2 49217902
Email 1686 0
Darren.Rivett@newcastle.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.