Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000335695
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
8/09/2005
Date last updated
8/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing falls risk in older people discharged from hospital: a randomised controlled trial comparing (i) seated lower limb resistance training, (ii) functional weight-bearing training and (iii) social visits (control activity).
Scientific title
Reducing falls risk in older people discharged from hospital: a randomised controlled trial comparing (i) seated lower limb resistance training, (ii) functional weight-bearing training and (iii) social visits (control activity).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls Risk factors 428 0
Condition category
Condition code
Public Health 498 498 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of 12 week programs of 1) seated resistance training, 2) functional weight-bearing exercises
Intervention code [1] 339 0
Rehabilitation
Comparator / control treatment
3) social visits (control)
Control group
Placebo

Outcomes
Primary outcome [1] 569 0
Quadriceps and other lower limb muscle strength measured using a spring balance and hand-held dynamometer
Timepoint [1] 569 0
Measured at baseline, and at 12 weeks (after completion of the exercise program) and at 24 weeks (to determine detraining)
Primary outcome [2] 570 0
Postural control/balance measured using a battery of four standardized tests (standing sway on foam, lateral stability, maximal balance range and coordinated stability)
Timepoint [2] 570 0
Measured at baseline, and at 12 weeks (after completion of the exercise program) and at 24 weeks (to determine detraining)
Secondary outcome [1] 1206 0
Physical performance and mobility examination
Timepoint [1] 1206 0
All tests are measured at baseline, and at 12 weeks (after completion of the exercise program) and at 24 weeks (to determine detraining).
Secondary outcome [2] 1207 0
Reaction time
Timepoint [2] 1207 0
All tests are measured at baseline, and at 12 weeks (after completion of the exercise program) and at 24 weeks (to determine detraining).
Secondary outcome [3] 1208 0
6 metre walking speed
Timepoint [3] 1208 0
All tests are measured at baseline, and at 12 weeks (after completion of the exercise program) and at 24 weeks (to determine detraining).
Secondary outcome [4] 1209 0
Falls efficacy
Timepoint [4] 1209 0
All tests are measured at baseline, and at 12 weeks (after completion of the exercise program) and at 24 weeks (to determine detraining).
Secondary outcome [5] 1210 0
Activities of daily living
Timepoint [5] 1210 0
All tests are measured at baseline, and at 12 weeks (after completion of the exercise program) and at 24 weeks (to determine detraining).
Secondary outcome [6] 1211 0
Quality of life.
Timepoint [6] 1211 0

Eligibility
Key inclusion criteria
Inpatient or consult of the Royal North Shore Hospital Aged Care Department service, inpatient of the General Medical or Neurology Department of RNSH, or inpatient or consult of the Geriatric and Rehabilitation service at Hornsby Hospital.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged less than 65 years, unable to speak English, medical contraindication to exercise,mobile with at least stand-by assistance and a walking aid, mini-mental state examination score 24 or above, not discharged to nursing home.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers using Microsoft excel software. This was done in blocks. There was no stratification
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
11/01/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 561 0
Government body
Name [1] 561 0
NHMRC Partnership Gran
Country [1] 561 0
Australia
Primary sponsor type
Other
Name
Prince of Wales Medical Research Institute
Address
Country
Australia
Secondary sponsor category [1] 454 0
University
Name [1] 454 0
University of Sydney
Address [1] 454 0
Country [1] 454 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1582 0
Human Research Ethics Committee - Royal North Shore Hospital
Ethics committee address [1] 1582 0
Ethics committee country [1] 1582 0
Australia
Date submitted for ethics approval [1] 1582 0
Approval date [1] 1582 0
Ethics approval number [1] 1582 0
Ethics committee name [2] 1583 0
Human Research Ethics Committee - University of Sydney
Ethics committee address [2] 1583 0
Ethics committee country [2] 1583 0
Australia
Date submitted for ethics approval [2] 1583 0
Approval date [2] 1583 0
Ethics approval number [2] 1583 0

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

Contacts
Principal investigator
Name 35372 0
Address 35372 0
Country 35372 0
Phone 35372 0
Fax 35372 0
Email 35372 0
Contact person for public queries
Name 9528 0
Constance Vogler
Address 9528 0
Department of Aged Care and Rehabilitation
Royal North Shore Hospital
Building 12
St Leonards NSW 2065
Country 9528 0
Australia
Phone 9528 0
+61 2 99267111
Fax 9528 0
Email 9528 0
[email protected]
Contact person for scientific queries
Name 456 0
Constance Vogler
Address 456 0
Department of Aged Care and Rehabilitation
Royal North Shore Hospital
Building 12
St Leonards NSW 2065
Country 456 0
Australia
Phone 456 0
+61 2 99267111
Fax 456 0
Email 456 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.