Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000081415
Ethics application status
Approved
Date submitted
23/01/2007
Date registered
24/01/2007
Date last updated
27/08/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Does rehabilitation improve walking performance?
Scientific title
The impact of a group exercise programme on usual walking performance in adults who are at least 6 months post stroke. A single blinded randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adults living in the community who are at least 6 months post stroke 1573 0
Stroke 2389 0
Condition category
Condition code
Stroke 1674 1674 0 0
Ischaemic
Stroke 1675 1675 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group: 12 1-hour sessions (3 times a week for 4 weeks) of circuit exercise programme consisting of strengthening and functional exercises graded according to individual ability. The exercises include sit to stand, single leg stance, step ups, tandem walk, swiss ball squats, standing hamstring curl, tandem stance, calf raise, backwards walk, lunges, self sway, walking around cones, obstacles, different surfaces, side leg lifts, marching in place and sitting and reaching.

The duration from entry to exit from the study will be five months.
Intervention code [1] 1572 0
Rehabilitation
Comparator / control treatment
Control group: 12 1-hour educational (3 times a week for 4 weeks) and social sessions. These will comprise of general education about healthy living and stroke and will also include a social "coffee morning" component. These sessions will be facilitated by a stroke nurse.
Control group
Active

Outcomes
Primary outcome [1] 2320 0
7 day mean step count (measured by StepWatch Activity Monitor).
Timepoint [1] 2320 0
Participants will wear the monitor for 7 days on three different occasions; immediately prior to the commencement of the intervention period; in the 3 weeks following the intervention period; and at 3 months following the intervention period.
Secondary outcome [1] 4044 0
10 metre walk test (gait speed).
Timepoint [1] 4044 0
All Secondary Outcomes will be measured at four timepoints: twice prior to the intervention at 3 weeks and immediately prior to the commencement of the intervention, immediately following the intervention and 3 months following the intervention.
Secondary outcome [2] 4045 0
6 minute walk test (gait endurance).
Timepoint [2] 4045 0
All Secondary Outcomes will be measured at four timepoints: twice prior to the intervention at 3 weeks and immediately prior to the commencement of the intervention, immediately following the intervention and 3 months following the intervention.
Secondary outcome [3] 4046 0
Activities-specific balance confidence scale (measure of confidence during functional activities).
Timepoint [3] 4046 0
All Secondary Outcomes will be measured at four timepoints: twice prior to the intervention at 3 weeks and immediately prior to the commencement of the intervention, immediately following the intervention and 3 months following the intervention.
Secondary outcome [4] 4047 0
Rivermead Mobility Index (self reported mobility).
Timepoint [4] 4047 0
All Secondary Outcomes will be measured at four timepoints: twice prior to the intervention at 3 weeks and immediately prior to the commencement of the intervention, immediately following the intervention and 3 months following the intervention.
Secondary outcome [5] 4048 0
Physical Activity and Disability Scale (self reported activity).
Timepoint [5] 4048 0
All Secondary Outcomes will be measured at four timepoints: twice prior to the intervention at 3 weeks and immediately prior to the commencement of the intervention, immediately following the intervention and 3 months following the intervention.

Eligibility
Key inclusion criteria
Inclusion Criteria: Criteria for inclusion in the study are adults who are at least six months post stroke, have been discharged from rehabilitation services, live in the community and have medical clearance to participate in an exercise programme. All participants will be able to walk independently (with assistive devices as necessary) but will still with some difficulty with walking as confirmed by the physical functioning scale of the Short Form 36 (SF36).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have progressive neurological disease, other significant health problems that adversely affect walking ability, more than 2 falls in the previous 6 months, unstable cardiac conditions, uncontrolled hypertension or congestive heart failure. Participants will be excluded if their initial gait speed is greater than 1 m/s, which is within 10% of the normal range for healthy older adults.

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)
Assignment will be made by an individual independent of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer generated numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor will be blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 476 0
New Zealand
State/province [1] 476 0

Funding & Sponsors
Funding source category [1] 1819 0
Charities/Societies/Foundations
Name [1] 1819 0
Neurological Foundation
Country [1] 1819 0
New Zealand
Funding source category [2] 1820 0
Charities/Societies/Foundations
Name [2] 1820 0
New Zealand Society of Physiotherapists
Country [2] 1820 0
New Zealand
Funding source category [3] 1821 0
Government body
Name [3] 1821 0
Health Research Council of New Zealand
Country [3] 1821 0
New Zealand
Primary sponsor type
University
Name
Department of Surgery, University of Auckland
Address
Private Bag 92019
Auckland 1020
Country
New Zealand
Secondary sponsor category [1] 1641 0
None
Name [1] 1641 0
Address [1] 1641 0
Country [1] 1641 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3408 0
Northern X Regional Ethics Committee
Ethics committee address [1] 3408 0
Private Bag 92522
Wellesley St,
Auckland
Ethics committee country [1] 3408 0
New Zealand
Date submitted for ethics approval [1] 3408 0
20/09/2006
Approval date [1] 3408 0
08/03/2007
Ethics approval number [1] 3408 0

Summary
Brief summary
Evidence supports the use of progressive strengthening, functional training, and aerobic exercise in stroke rehabilitation, with improvements noted even when patients are more than 6 months after stroke. However, limitations of current studies are that the main outcomes are measured in a clinical environment, which may not relate to a change in usual activity in an individual’s usual environment. Recently activity monitors have been introduced as a way to measure walking during usual activity and for longer periods.
Although it is known that rehabilitation exercise programmes can improve strength, walking speed and endurance and balance following stroke, it is not known whether this translates into the change in the amount or speed of walking that an individual does in their home or community environments. This study aims to look at the effects of a group exercise programme to see if it changes walking (as measured by an activity monitor) in home and community environments as well as walking as it is usually measured (with tests in a physiotherapy clinic).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27506 0
Address 27506 0
Country 27506 0
Phone 27506 0
Fax 27506 0
Email 27506 0
Contact person for public queries
Name 10761 0
Suzie Mudge
Address 10761 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland 1142
Country 10761 0
New Zealand
Phone 10761 0
+64 9 3737599 ext. 85387
Fax 10761 0
+64 9 367 7159
Email 10761 0
[email protected]
Contact person for scientific queries
Name 1689 0
Suzie Mudge
Address 1689 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland 1142
Country 1689 0
New Zealand
Phone 1689 0
+64 9 3737599 ext. 85387
Fax 1689 0
+64 9 367 7159
Email 1689 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

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