Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000346673
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial to evaluate task-related exercise classes for older people with impaired mobility
Scientific title
A randomised controlled trial to evaluate the effects of task-related exercise classes on physical ability among older people with impaired mobility.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older people with impaired mobility 440 0
Condition category
Condition code
Other 513 513 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 weeks of exercise classes.
Intervention code [1] 350 0
Rehabilitation
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 582 0
Balance
Timepoint [1] 582 0
Measured after the 5-week intervention.
Primary outcome [2] 583 0
Strength
Timepoint [2] 583 0
Measured after the 5-week intervention.
Primary outcome [3] 584 0
Functional ability
Timepoint [3] 584 0
Measured after the 5-week intervention.
Primary outcome [4] 585 0
Endurance
Timepoint [4] 585 0
Measured after the 5-week intervention.
Secondary outcome [1] 1238 0
Subjects' impression of the exercise program
Timepoint [1] 1238 0
Measured after the 5-week intervention period.

Eligibility
Key inclusion criteria
Subjects have a level of physical disability which precluded them from attending existing community-based exercise classes, are not concurrently receiving any rehabilitation intervention, and do not have severe respiratory or cardiac disease.
Minimum age
Not stated
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)
Opaque sealed enveloped.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software (Excel) and blocking.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Control group receives intervention after end of study period
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 574 0
Government body
Name [1] 574 0
NHMRC Health Research Partnership Grant
Country [1] 574 0
Australia
Primary sponsor type
Other
Name
Prince of Wales Medical Research Institute
Address
Country
Australia
Secondary sponsor category [1] 465 0
Hospital
Name [1] 465 0
Bankstown-Lidcombe Hospital
Address [1] 465 0
Country [1] 465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1595 0
Bankstown-Lidcombe Hospital
Ethics committee address [1] 1595 0
Ethics committee country [1] 1595 0
Australia
Date submitted for ethics approval [1] 1595 0
Approval date [1] 1595 0
Ethics approval number [1] 1595 0
Ethics committee name [2] 1596 0
War Memorial Hospital
Ethics committee address [2] 1596 0
Ethics committee country [2] 1596 0
Australia
Date submitted for ethics approval [2] 1596 0
Approval date [2] 1596 0
Ethics approval number [2] 1596 0

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

Contacts
Principal investigator
Name 36188 0
Address 36188 0
Country 36188 0
Phone 36188 0
Fax 36188 0
Email 36188 0
Contact person for public queries
Name 9539 0
Catherine Sherrington
Address 9539 0
Prince of Wales Medical Research Institute
Barker St
Randwick NSW 2031
Country 9539 0
Australia
Phone 9539 0
+61 2 93991063
Fax 9539 0
+61 2 939911005
Email 9539 0
c.sherrington@unsw.edu.au
Contact person for scientific queries
Name 467 0
Catherine Sherrington
Address 467 0
Prince of Wales Medical Research Institute
Barker St
Randwick NSW 2031
Country 467 0
Australia
Phone 467 0
+61 2 93991063
Fax 467 0
+61 2 939911005
Email 467 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.