Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000479505
Ethics application status
Approved
Date submitted
13/11/2006
Date registered
20/11/2006
Date last updated
28/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise intervention to prevent falls, enhance mobility and increase physical activity in community dwellers after stroke: a randomised controlled trial
Scientific title
Exercise intervention to prevent falls, enhance mobility and increase physical activity in community dwellers after stroke: a randomised controlled trial
Secondary ID [1] 259688 0
The Stroke Club trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals after stroke residing in the community 1456 0
Condition category
Condition code
Stroke 1552 1552 0 0
Haemorrhagic
Stroke 237098 237098 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 group- weekly exercise class ( 45 min per class, 40 weeks per year) and home program (up to 30 min, 5 days/week) aimed at preventing falls, enhancing mobility and increasing physical activity for 12 months.
Intervention code [1] 1442 0
Lifestyle
Comparator / control treatment
1 group - weekly upper limb and cognitive exercise class (45 min per class, 40 weeks) and home program (up to 30 min, 5 days per week) aimed at improving affected upper limb function and cognition for 12 months
Control group
Active

Outcomes
Primary outcome [1] 2142 0
Falls
Timepoint [1] 2142 0
Measured monthly for 12 month study period
Primary outcome [2] 2143 0
10m walk speed
Timepoint [2] 2143 0
Measured at baseline and within a month of completing the 12 month study period
Primary outcome [3] 2144 0
6 min walk distance
Timepoint [3] 2144 0
Measured at baseline and within one month of completing the 12 month study period
Secondary outcome [1] 3709 0
Falls risk factors
Timepoint [1] 3709 0
Measured at baseline and within 1 month of completing the 12 month study period.
Secondary outcome [2] 3710 0
Mobility
Timepoint [2] 3710 0
Measured at baseline and within 1 month of completing the 12 month study period.
Secondary outcome [3] 3711 0
Habitual physical activity
Timepoint [3] 3711 0
Measured at baseline and within 1 month of completing the 12 month study period.
Secondary outcome [4] 3712 0
Community participation
Timepoint [4] 3712 0
Measured at baseline and within 1 month of completing the 12 month study period.
Secondary outcome [5] 3713 0
Quality of life
Timepoint [5] 3713 0
Measured at baseline and within 1 month of completing the 12 month study period.
Secondary outcome [6] 3714 0
Muscle extensibility
Timepoint [6] 3714 0
Measured at baseline and within 1 month of completing the 12 month study period.
Secondary outcome [7] 3715 0
Upper limb function
Timepoint [7] 3715 0
Measured at baseline and within 1 month of completing the 12 month study period.
Secondary outcome [8] 3716 0
Cognition
Timepoint [8] 3716 0
Measured at baseline and within 1 month of completing the 12 month study period.

Eligibility
Key inclusion criteria
Suffered one or more strokes; Able to walk 10 m independently with or without an aid; able to gain medical clearance to participate; able to give informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment (Mini-Mental State Examination (MMSE) score less than 24); Insufficient communication or english language skills to participate safely; medical condition precluding exercise.

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)
sealed, sequentially numbered opaque envelopes, opened by a person independent of the study at a central independent location
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence using Microsoft excel. Randomisation stratified within each stroke club with size and order of blocks random.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessor and data analyst are blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 416 0
New Zealand
State/province [1] 416 0

Funding & Sponsors
Funding source category [1] 1692 0
Government body
Name [1] 1692 0
NSW Health Promotion Demonstration Research Grant Scheme
Country [1] 1692 0
Australia
Primary sponsor type
Government body
Name
NSW Health
Address
NSW Health
73 millers St
North Sydney
NSWw 2060
Country
Australia
Secondary sponsor category [1] 1493 0
University
Name [1] 1493 0
The University of Sydney
Address [1] 1493 0
Faculty of health Sciences
The Unversity of Sydney
PO Box 170
Lidcombe NSW 1825
Country [1] 1493 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3141 0
Sydney South Westh Area Health Service
Ethics committee address [1] 3141 0
Ethics committee country [1] 3141 0
Australia
Date submitted for ethics approval [1] 3141 0
Approval date [1] 3141 0
25/05/2006
Ethics approval number [1] 3141 0
X06-0039
Ethics committee name [2] 3142 0
The University of Sydney -SSWAHS Ethic Review Committee .
Ethics committee address [2] 3142 0
Ethics committee country [2] 3142 0
Australia
Date submitted for ethics approval [2] 3142 0
Approval date [2] 3142 0
16/06/2006
Ethics approval number [2] 3142 0
Ethics committee name [3] 3143 0
Stroke Clubs within the network of Stroke Recovery Association of NSW.
Ethics committee address [3] 3143 0
Ethics committee country [3] 3143 0
Australia
Date submitted for ethics approval [3] 3143 0
Approval date [3] 3143 0
Ethics approval number [3] 3143 0

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

Contacts
Principal investigator
Name 27376 0
Address 27376 0
Country 27376 0
Phone 27376 0
Fax 27376 0
Email 27376 0
Contact person for public queries
Name 10631 0
Dr Catherine Dean
Address 10631 0
Discipline of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 10631 0
Australia
Phone 10631 0
+61 2 93519266
Fax 10631 0
+ 61 2 93519278
Email 10631 0
[email protected]
Contact person for scientific queries
Name 1559 0
Associate Professor Chris Rissel
Address 1559 0
Director
Health Promotion Unit
Sydney South West Area Health Service
Level 9 King George V Building
Missenden Rd
Camperdown NSW 2050
Country 1559 0
Australia
Phone 1559 0
+61 2 95159080
Fax 1559 0
+61 2 95159056
Email 1559 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.