Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000563460
Ethics application status
Approved
Date submitted
29/10/2007
Date registered
1/11/2007
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimising disability and falls in older people through a post-hospital individualised exercise program.
Scientific title
In people who have had recent hospital stays, can an exercise program prevent falls and improve mobility compared with usual care?
Secondary ID [1] 285066 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 2514 0
impaired mobility 2515 0
Condition category
Condition code
Public Health 2610 2610 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise program. A home exercise program based on the Weight-bearing Exercise for Better Balance program will be established in 10 1-hour visits from a physiotherapist over the 12-month study period. The exercises will be individually prescribed by experienced physiotherapists and will target postural control (balance) and lower limb muscle strength. The participants will be asked to continue to exercises for the 12-month study period. The frequency and duration will be individually prescribed and will be up to 30 minutes 6 times a week. Participants will not be required to continue to exercise after the completion of the study period but may do so if they wish.
Intervention code [1] 2241 0
Rehabilitation
Intervention code [2] 2251 0
Comparator / control treatment
Usual care. This will vary between indivudals and may include health services contact.
Control group
Active

Outcomes
Primary outcome [1] 3522 0
Falls
Timepoint [1] 3522 0
12 months
Primary outcome [2] 3523 0
Mobility (self-reported and performance-based)
Timepoint [2] 3523 0
12 months
Secondary outcome [1] 5875 0
Falls risk factors
Timepoint [1] 5875 0
12 months
Secondary outcome [2] 5876 0
Quality of life
Timepoint [2] 5876 0
12 months
Secondary outcome [3] 5877 0
Mobility (physical performance test)
Timepoint [3] 5877 0
12 months

Eligibility
Key inclusion criteria
Recent hospital stay
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unfit for exercise
Progressive neurological condition
Cognitive impairment
Nursing home resident

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)
Informed consent
Baseline assessment
Central randomisation by an investigator not involved in recruitment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification by number of past falls
Random permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2007
Actual
11/10/2007
Date of last participant enrolment
Anticipated
Actual
14/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
340
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 310 0
2065
Recruitment postcode(s) [2] 311 0
2031

Funding & Sponsors
Funding source category [1] 2757 0
Government body
Name [1] 2757 0
National Health & Medical Research Council (NHMRC)
Country [1] 2757 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The George Institute for International Health, PO Box M201, Missenden Road, Sydney NSW 2050
Country
Australia
Secondary sponsor category [1] 2491 0
University
Name [1] 2491 0
Prince of Wales Medical Research Institute
Address [1] 2491 0
Barker St Randwick Sydney
Country [1] 2491 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4678 0
University of Sydney
Ethics committee address [1] 4678 0
NSW 2006
Ethics committee country [1] 4678 0
Australia
Date submitted for ethics approval [1] 4678 0
Approval date [1] 4678 0
12/12/2006
Ethics approval number [1] 4678 0
12-2006/9682

Summary
Brief summary
This study aims:
1. To implement a tailored exercise program designed to minimise disability and falls among older adults who have recently had a hospital stay.
2.To conduct a randomised controlled trial to determine:
- the success of the program in minimising disability and falls;
- the effects of the program on risk factors for falls and quality of life
Trial website
Trial related presentations / publications
Sherrington C, Lord SR, Vogler CM, Close JCT, Howard K, Dean CM, Heller GZ, Clemson L, O’Rourke SD, Ramsay E, Barraclough E, Herbert RD, Cumming RG. A post-hospital home exercise program improved mobility but increased falls in older people: a randomised controlled trial. PLOS ONE. In press (accepted 9 July 2014.)
Public notes

Contacts
Principal investigator
Name 28153 0
Prof Cathie Sherrington
Address 28153 0
The George Institute for Global Health, PO Box M201, Missenden Rd, NSW 2050 Australia
Country 28153 0
Australia
Phone 28153 0
+61 2 9657 0300
Fax 28153 0
Email 28153 0
[email protected]
Contact person for public queries
Name 11310 0
Prof Prof Cathie Sherington
Address 11310 0
The George Institute for Global Health, PO Box M201, Missenden Road, Sydney NSW 2050
Country 11310 0
Australia
Phone 11310 0
+ 612 9657 0300
Fax 11310 0
+ 612 9657 0301
Email 11310 0
[email protected]
Contact person for scientific queries
Name 2238 0
Prof Prof Cathie Sherrington
Address 2238 0
The George Institute for Global Health, PO Box M201, Missenden Road, Sydney NSW 2050
Country 2238 0
Australia
Phone 2238 0
+612 9657 0300
Fax 2238 0
+ 612 9657 0301
Email 2238 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
SourceTitleYear of PublicationDOI
EmbaseHealth and social support services in older adults recently discharged from hospital: service utilisation and costs and exploration of the impact of a home-exercise intervention.2016https://dx.doi.org/10.1186/s12877-016-0254-x
N.B. These documents automatically identified may not have been verified by the study sponsor.