Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000506493
Ethics application status
Approved
Date submitted
26/09/2007
Date registered
5/10/2007
Date last updated
14/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a higher intensity water-based exercise program: a randomized controlled trial following stroke (pilot)
Scientific title
The effectiveness of higher intensity water- and gym-based exercise programs on gait speed: a randomised controlled trial following stroke (pilot)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 2400 0
Condition category
Condition code
Stroke 2504 2504 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A water-based intervention consisting of three pool sessions per week for a total of six weeks. Each session will be 40 minutes duration and consist of a standardised resistance program, the intensity of which will be varied according to each individual's ability, with progressive increase in load over the six week period.
Intervention code [1] 2123 0
Rehabilitation
Comparator / control treatment
Group 1 will consist of a gym-based intervention consisting of three gym sessions per week for a total of six weeks. Each session will be 40 minutes duration and consist of a standardised resistance program, the intensity of which will be varied according to each individual's ability, with progressive increase in load over the six week period.

Group 2 will consist of attendance at a chronic disease self management course once a week for six weeks. Each session will be 2.5 hours duration and will consist of instruction on how to manage symptoms, effectively communicate with your doctor, lessen frustration, fight fatigue, make daily tasks easier, and get more out of life.
Control group
Active

Outcomes
Primary outcome [1] 3400 0
Six minute walk test
Timepoint [1] 3400 0
Baseline, immediately post intervention, 3 months post intervention.
Secondary outcome [1] 5648 0
Modified Berg Balance Scale
Timepoint [1] 5648 0
Baseline, immediately post intervention, 3 months post intervention.
Secondary outcome [2] 5649 0
Bioelectrical Impedance
Timepoint [2] 5649 0
Baseline, immediately post intervention, 3 months post intervention.
Secondary outcome [3] 5650 0
Functional independence using the Modified Barthel Index
Timepoint [3] 5650 0
Baseline, immediately post intervention, 3 months post intervention.
Secondary outcome [4] 5651 0
Goal Attainment Scale
Timepoint [4] 5651 0
Baseline, immediately post intervention, 3 months post intervention.
Secondary outcome [5] 5652 0
Quality of Life using EuroQoL
Timepoint [5] 5652 0
Baseline, immediately post intervention, 3 months post intervention.
Secondary outcome [6] 5653 0
Motor Assessment Scale
Timepoint [6] 5653 0
Baseline, immediately post intervention, 3 months post intervention.
Secondary outcome [7] 5654 0
The Medical Outcomes Study (MOS) Sleep Scale
Timepoint [7] 5654 0
Baseline, immediately post intervention, 3 months post intervention.
Secondary outcome [8] 5655 0
Fatigue Assessment Scale
Timepoint [8] 5655 0
Baseline, immediately post intervention, 3 months post intervention.

Eligibility
Key inclusion criteria
6 months to 3 years since first stroke (ischemic stroke or primary intracerebral haemorrhage), community dwelling, independent ambulation with or without gait aids, Mini Mental State Exam score fo at least 18, ability to accept instruction and give consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subsequent stroke, major medical complications following stroke, unstable cardiac conditions, urinary or faecal incontinence, open wounds, tinea, unstable epilepsy or seizures, other comorbid conditions that might contraindicate participation in gym- or water-based exercise, inability to carry out the ecercise program, current participation in an exercise program

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2652 0
University
Name [1] 2652 0
Flinders University
Country [1] 2652 0
Australia
Primary sponsor type
Individual
Name
Maria Crotty
Address
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 2400 0
None
Name [1] 2400 0
Address [1] 2400 0
Country [1] 2400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4570 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 4570 0
Daws Road
Daw Park Sa 5041
Ethics committee country [1] 4570 0
Australia
Date submitted for ethics approval [1] 4570 0
Approval date [1] 4570 0
25/09/2007
Ethics approval number [1] 4570 0
32/06

Summary
Brief summary
In any year, there are approximately 48,000 stroke events amongst Australians. Most patients will experience severe cardiovascular de-conditioning after a stroke and around 21% will experience a decline in mobility which leads to a disruption in usual functioning and may affect social reintegration. For this reason, improving physical fitness may both counteract the deficits frequently resulting from a stroke and play a role in the secondary prevention of cardiovascular disease.

While recent Australian clinical guidelines for rehabilitation after stroke have recommended that programmes should include interventions to improve cardiovascular fitness, they provide no information on the components of the most effective programme. Water-based exercise is possible for patients who are non-ambulatory or have balance issues and previous studies have demonstrated high levels of adherence to water-based programmes.

The study will compare higher intensity water-based exercise with gym-based exercise of similar intensity for patients within three years of their first stroke. Given the susceptibility of this patient group to functional deterioration, this trial will inform the current debate on the optimal features of programmes designed to improve function and physical fitness following stroke. The current lack of scientifically rigorous research in this area ensures that its results would have immediate application to the content of rehabilitation programmes overall. It is anticipated that the water environment will allow patients to exercise at a higher level than would have been possible on land, translating into greater improvements to function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28073 0
Address 28073 0
Country 28073 0
Phone 28073 0
Fax 28073 0
Email 28073 0
Contact person for public queries
Name 11230 0
Dr Simon Gunn
Address 11230 0
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 11230 0
Australia
Phone 11230 0
08 8275 1103
Fax 11230 0
08 8275 1130
Email 11230 0
[email protected]
Contact person for scientific queries
Name 2158 0
Dr Simon Gunn
Address 2158 0
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 2158 0
Australia
Phone 2158 0
08 8275 1103
Fax 2158 0
08 8275 1130
Email 2158 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.