Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000414617
Ethics application status
Approved
Date submitted
11/09/2005
Date registered
15/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A novel weight-bearing resistance training program for inpatient aged care rehabilitation: comparison with a non-weight-bearing program in a randomised controlled trial.
Scientific title
Effects on strength and functional ability of a novel weight-bearing resistance training program for inpatient aged care rehabilitation: comparison with a non-weight-bearing program in a randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty in older people 522 0
Condition category
Condition code
Physical Medicine / Rehabilitation 603 603 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two weeks of weight-bearing resistance training is compared with two weeks of non weight-bearing resistance training.
Intervention code [1] 459 0
Rehabilitation
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 697 0
Quadriceps strength
Timepoint [1] 697 0
After 2 weeks of intervention
Primary outcome [2] 698 0
Sit to stand ability
Timepoint [2] 698 0
After 2 weeks of intervention
Secondary outcome [1] 1436 0
Other lower limb muscle strength, gait and functional ability.
Timepoint [1] 1436 0
After two weeks of intervention.

Eligibility
Key inclusion criteria
Rehabilitation unit inpatients with no contraindications to exercise over the age of 60 and unable to stand up from a 35cm chair without using their hands.
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Group allocation in opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated from a random number table in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 657 0
Charities/Societies/Foundations
Name [1] 657 0
Physiotherapy Research Foundation
Country [1] 657 0
Australia
Funding source category [2] 658 0
Charities/Societies/Foundations
Name [2] 658 0
NSW Australian Physiotherapy Association
Country [2] 658 0
Australia
Funding source category [3] 659 0
Charities/Societies/Foundations
Name [3] 659 0
Health Research Foundation Sydney South West
Country [3] 659 0
Australia
Primary sponsor type
Hospital
Name
Bankstown-Lidcombe Hospital
Address
Country
Australia
Secondary sponsor category [1] 549 0
None
Name [1] 549 0
None
Address [1] 549 0
Country [1] 549 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35393 0
Address 35393 0
Country 35393 0
Phone 35393 0
Fax 35393 0
Email 35393 0
Contact person for public queries
Name 9648 0
Dr Catherine Sherrington
Address 9648 0
Medical Research Institute
Prince of Wales
Barker St
Randwick NSW 2031
Country 9648 0
Australia
Phone 9648 0
+61 2 93991063
Fax 9648 0
+61 2 93991005
Email 9648 0
c.sherrington@unsw.edu.au
Contact person for scientific queries
Name 576 0
Dr Catherine Sherrington
Address 576 0
Medical Research Institute
Prince of Wales
Barker St
Randwick NSW 2031
Country 576 0
Australia
Phone 576 0
+61 2 93991063
Fax 576 0
+61 2 93991005
Email 576 0
c.sherrington@unsw.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.