Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000180415
Ethics application status
Approved
Date submitted
21/03/2007
Date registered
22/03/2007
Date last updated
22/03/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment and prevention of falls, functional decline and hospital re-admission in older adults post-hospitalisation
Scientific title
Effect of DVD exercise program compared to usual care for reducing falls, functional decline and hospital re-admissions amongst older adults post-hospitalisation
Universal Trial Number (UTN)
Trial acronym
KTEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of falls, functional decline and hospital re-admission in older adults post hospitalisation 1698 0
Condition category
Condition code
Injuries and Accidents 1790 1790 0 0
Other injuries and accidents
Public Health 1791 1791 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION:
Self-progressed home exercise program in DVD and booklet format, to be completed at least 3 times per week. Each session will be 30 minutes. The program will include exercises to address balance, hip control, weight shift, lower limb strength and endurance, and components of walking. Participants are to complete the exercise program no more than 7 times per week. The participants will be actively monitored and encouraged to participate for 8 weeks, followed by a 18 week period without active encouragement.
Intervention code [1] 1648 0
Rehabilitation
Comparator / control treatment
CONTROL:
Usual daily activities
Control group
Active

Outcomes
Primary outcome [1] 2507 0
Mean 5 dimensional EuroQol with visual analogue scale (EQ-5D & VAS) form
Timepoint [1] 2507 0
At discharge, 7 weeks, 2 months, and 6 months
Primary outcome [2] 2508 0
Incidence of falls
Timepoint [2] 2508 0
At discharge, self recording of all falls for 6 months and then monthly phone calls for 6 months
Primary outcome [3] 2509 0
Incidence of hospital re-admission
Timepoint [3] 2509 0
6 months.
Primary outcome [4] 2510 0
Frenchay activities index
Timepoint [4] 2510 0
At discharge, 7 weeks, 2 months and 6 months
Secondary outcome [1] 4319 0
Balance outcome measure for elder rehabilitation.
Timepoint [1] 4319 0
At discharge and 2 months
Secondary outcome [2] 4320 0
Activities-specific Balance Confidence
Timepoint [2] 4320 0
At discharge and 2 months
Secondary outcome [3] 4321 0
Gaitrite: velocity, cadence and double limb support
Timepoint [3] 4321 0
At discharge and 2 months
Secondary outcome [4] 4322 0
Health service resources
Timepoint [4] 4322 0
At 6 months
Secondary outcome [5] 4323 0
Contingent valuation
Timepoint [5] 4323 0
At 6 months

Eligibility
Key inclusion criteria
Use a gait aid to mobilise-discharged from hospital to a community dwelling- Not referred for post-discharge community rehabilitation services.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable severe cardiac disease- Cognitive impairment (Mini-Mental State Examination [MMSE] < 23)- Aggressive behaviour- Restricted weight-bearing status.

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)
Patients being discharged from hospital will be approached for consent. Allocation via sequential opening of opaque envelopes containing computer generated random number sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence by investigator not involved in recruitment or assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The follow-up assessor is blinded to the participant's group allocation
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1941 0
Government body
Name [1] 1941 0
Queensland Health Allied Health Community Rehabilitation Scheme
Country [1] 1941 0
Australia
Primary sponsor type
Individual
Name
Dr Terry Haines
Address
Country
Secondary sponsor category [1] 1752 0
Individual
Name [1] 1752 0
Dr Jan Jasiewicz
Address [1] 1752 0
Country [1] 1752 0
Secondary sponsor category [2] 1753 0
Individual
Name [2] 1753 0
Dr Trevor Russell
Address [2] 1753 0
Country [2] 1753 0
Secondary sponsor category [3] 1754 0
Individual
Name [3] 1754 0
Dr Steven Urry
Address [3] 1754 0
Country [3] 1754 0
Secondary sponsor category [4] 1755 0
Individual
Name [4] 1755 0
Dr Sandra Brauer
Address [4] 1755 0
Country [4] 1755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3619 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 3619 0
Ethics committee country [1] 3619 0
Australia
Date submitted for ethics approval [1] 3619 0
Approval date [1] 3619 0
06/12/2006
Ethics approval number [1] 3619 0
EC00167

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

Contacts
Principal investigator
Name 27582 0
Address 27582 0
Country 27582 0
Phone 27582 0
Fax 27582 0
Email 27582 0
Contact person for public queries
Name 10837 0
Dr Terry Haines
Address 10837 0
c/o Physiotherapy Department
Geriatric Assessment and Rehabilitation Unit (GARU)
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country 10837 0
Australia
Phone 10837 0
+61 7 32406713
Fax 10837 0
Email 10837 0
Terrence_Haines@health.qld.gov.au
Contact person for scientific queries
Name 1765 0
Dr Terry Haines
Address 1765 0
c/o Physiotherapy Department
Geriatric Assessment and Rehabilitation Unit (GARU)
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country 1765 0
Australia
Phone 1765 0
+61 7 32406713
Fax 1765 0
Email 1765 0
Terrence_Haines@health.qld.gov.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.