Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000325404
Ethics application status
Approved
Date submitted
25/02/2016
Date registered
11/03/2016
Date last updated
11/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting physical activity after stroke via self-management: A pilot randomised
trial.
Scientific title
Promoting physical activity after stroke via self-management: A pilot randomised
trial.
Secondary ID [1] 288622 0
Nil known
Universal Trial Number (UTN)
U1111-1180-0564
Trial acronym
PPASS RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals following acute stroke, living in the community
 297775 0
Condition category
Condition code
Stroke 297959 297959 0 0
Ischaemic
Stroke 297960 297960 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 297961 297961 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A standardised protocol for the self-management intervention has been developed incorporating elements important to behaviour change (Abraham and Michie, 2008), and will be implemented in 5 sessions by trained physiotherapists.

All sessions will be allocated 60 minutes and will be implemented in collaboration with the participant in the participant’s home. The first two intervention sessions will be delivered at 1-week intervals, the third after a 2-week interval, and the fourth and fifth after 4-week intervals.

Session 1 includes education about the importance of physical activity, completion of an physical activity preferences questionnaire and generation of a list of goals, barriers and potential solutions.

Session 2 includes revision of goals, barriers and solutions, development of a weekly physical activity schedule, selection of self-monitoring strategies, and implementation of the initial physical activity session.

Session 3 includes feedback about initial measurement outcomes, revision of goals and self-monitoring strategies, revision of the physical activity schedule, encouragement and praise.

Session 4 includes revision of goals and self-monitoring strategies, relapse prompting, encouragement and praise.

Session 5 includes feedback about 3 month measurement outcomes, revision of physical activity, relapse prompting, encouragement and praise.

The intervention is self-management, not physical activity prescription, so participants will decide on the type, intensity, duration and mode of physical activity individually. These elements will not be prescribed. Participants will be informed that 150 minutes of physical activity a week is recommended by Australia's Physical Activity and Sedentary Behaviour Guidelines', (Department of Health, 2014). Participants will also be guided to select a strategy for monitoring their physical activity, which again will be decided by the participant. Adherence to the self-management program will be determined by attendance at self-management sessions.
Intervention code [1] 294024 0
Lifestyle
Intervention code [2] 294025 0
Rehabilitation
Comparator / control treatment
The control group will receive usual practice, including advice to increase physical activity and will be provided with the consumer advice booklet Make yourself strokesafe 'Trademark"; Understand and prevent stroke (National Stroke Foundation, 2009).
Control group
Active

Outcomes
Primary outcome [1] 297479 0
Proportion of participants who meet Australia's Physical Activity and Sedentary Behaviour Guidelines (Department of Health, 2014) will be measured via the Actigraph activity monitor, which will monitor physical activity during waking hours for a week.
Timepoint [1] 297479 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [1] 321158 0
Time spent in moderate activity (min/day) via the Actigraph activity monitor, which will be worn for all waking hours for 7 days.
Timepoint [1] 321158 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [2] 321159 0
Walking ability using the 6-min walk test
Timepoint [2] 321159 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [3] 321160 0
Participation using the Impact on Participation and Autonomy Questionnaire(IPAQ)
Timepoint [3] 321160 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [4] 321163 0
health-related quality of life using the EuroQual-5D (EQ-5D)
Timepoint [4] 321163 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [5] 321164 0
Self efficacy will be measured using the Self-efficacy for Exercise scale (Resnick and Jenkins, 2000).
Timepoint [5] 321164 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [6] 321165 0
Health status measured via Australian absolute cardivascular risk calculator. An automatic sphygmomanometer will be used to measure blood pressure. LDL and HDL will be taken from participants' medical records.
Timepoint [6] 321165 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [7] 321428 0
Walking ability measured using the 10-m walk test
Timepoint [7] 321428 0
Baseline, Post (3 months) and Follow-up (6 months)
Secondary outcome [8] 321657 0
Number of steps (number/day) via the Actigraph activity monitor, which will be worn for all waking hours for 7 days.
Timepoint [8] 321657 0
Baseline, 3 months and 6 months

Eligibility
Key inclusion criteria
People after haemorrhagic or ischaemic stroke who are:
1. To be discharged home from an acute medical/stroke unit within one month of stroke onset
2. Able to walk 10m across flat ground without an aid at greater than or equal to 0.8m/s. (12.5s on 10MWT)
3. Score greater than or equal to 24 on the Mini Mental State Examination
4. Perform fewer than 30 minutes of moderate activity most days a week..
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke survivors with moderate to severe receptive aphasia (i.e.<25/30 on the Frenchay Screening Aphasia Test

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)
Randomisation will be centralised off-site, thereby concealing the sequence of group allocation from the researcher recruiting participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer-generated. Random permuted blocks will be used so that both groups contain equal numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proportion of stroke survivors meeting the national physical activity guideline will be compared between the two groups using the Chi square test. Amount of physical activity, walking ability, participation, quality of life, self-efficacy and health status will be compared between the groups using a repeated-measure ANCOVA with the baseline score as the co-variate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2016
Actual
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 5341 0
The Canberra Hospital - Garran
Recruitment hospital [2] 5342 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [3] 5344 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 12799 0
2605 - Garran
Recruitment postcode(s) [2] 12800 0
2617 - Bruce
Recruitment postcode(s) [3] 12802 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 292977 0
Charities/Societies/Foundations
Name [1] 292977 0
National Stroke Foundation
Country [1] 292977 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University Dr, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 291748 0
University
Name [1] 291748 0
Macquarie University
Address [1] 291748 0
Sydney NSW 2109
Country [1] 291748 0
Australia
Secondary sponsor category [2] 291753 0
Hospital
Name [2] 291753 0
The Canberra Hospital (ACT Health)
Address [2] 291753 0
Yamba Drive,
Garran, ACT 2605
Country [2] 291753 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294486 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 294486 0
Building 10, Level 6
The Canberra Hospital
Yamba Drive,
Garran, ACT 2605
Ethics committee country [1] 294486 0
Australia
Date submitted for ethics approval [1] 294486 0
06/01/2016
Approval date [1] 294486 0
22/02/2016
Ethics approval number [1] 294486 0
ETH.1.16.009
Ethics committee name [2] 294487 0
University of Canberra Human Research Ethics Committee
Ethics committee address [2] 294487 0
University Drive,
Bruce, ACT 2617
Ethics committee country [2] 294487 0
Australia
Date submitted for ethics approval [2] 294487 0
22/02/2016
Approval date [2] 294487 0
24/02/2016
Ethics approval number [2] 294487 0
UC ref number 2015000374

Summary
Brief summary
This study aims to determine whether self-management, and self-management support from a physiotherapist, can assist people after mild stroke to increase physical activity levels. Self-management, in this case, is when patients make the decisions about their own health and physical activity, with the assistance and support of a physiotherapist. Physical activity is important after stroke because it reduces the risks associated with recurrent stroke, such as high blood pressure, high cholesterol and high blood sugars. Research has also shown a direct link between increased physical activity and decreased risk of stroke. Many people after mild stroke do not participate in a healthy amount of physical activity, even though they are physically capable of doing so. A physiotherapist will provide 5 sessions of support to people after mild stroke over a 3 month period, which will include education, generation of goals, barriers and solutions for being physically active, development of a weekly physical activity schedule, selection of strategies to monitor physical activity, feedback, encouragement and praise. It is expected that this will result in stroke survivors completing a healthy amount of physical activity each week, as well as improving their confidence in their ability to be physically active, and improving their health status, such as blood pressure, cholesterol, and blood sugars. This group will be compared with a control group, who receive an information booklet only.
Trial website
Trial related presentations / publications
Preston E, Ada L, Dean CM, Stanton R, Waddington, G (2015) Promoting physical activity after stroke via self-management: A feasibility trial. International Journal of Stroke 10 (Suppl. 2); p. 76.
Preston E, Ada L, Dean CM, Stanton R, Waddington, G (2014) Promoting physical activity after stroke via self-management: Protocol for a feasibility trial. International Journal of Stroke 9 (Suppl. 2); 13.
Public notes

Contacts
Principal investigator
Name 63890 0
Dr Elisabeth Preston
Address 63890 0
University of Canberra
Discipline of Physiotherapy
Faculty of Health
Building 12
Moana St
Bruce ACT 2617
Country 63890 0
Australia
Phone 63890 0
+ 61 421049057
Fax 63890 0
Email 63890 0
[email protected]
Contact person for public queries
Name 63891 0
Dr Elisabeth Preston
Address 63891 0
University of Canberra
Discipline of Physiotherapy
Faculty of Health
Building 12
Moana St
Bruce ACT 2617
Country 63891 0
Australia
Phone 63891 0
+ 61 2 6201 5749
Fax 63891 0
Email 63891 0
[email protected]
Contact person for scientific queries
Name 63892 0
Dr Elisabeth Preston
Address 63892 0
University of Canberra
Discipline of Physiotherapy
Faculty of Health
Building 12
Moana St
Bruce ACT 2617
Country 63892 0
Australia
Phone 63892 0
+ 61 2 6201 5749
Fax 63892 0
Email 63892 0
[email protected]

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