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Trial registered on ANZCTR


Registration number
ACTRN12614000205639
Ethics application status
Approved
Date submitted
2/09/2013
Date registered
26/02/2014
Date last updated
26/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting physical activity after stroke via self management: A feasibility trial
Scientific title
Promoting physical activity after stroke via self management: A feasibility trial
Secondary ID [1] 283084 0
Nil
Universal Trial Number (UTN)
Trial acronym
PPASS Feasibility
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals following acute stroke, living in the community 289920 0
Condition category
Condition code
Stroke 290293 290293 0 0
Ischaemic
Stroke 290294 290294 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 290971 290971 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be self-management. Self-management involves the stroke survivor (and family/carers as appropriate) working in partnership with their health care provider, both via face to face visits and telephone discussions. The intervention will be delivered in 5 face to face visits of 60-90 minutes duration, with phone discussions as required by the partipant, over a three month period, and will commence within the first month following discharge. The visits will occur 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after discharge from hospital. Intervention will consist of the following:
1. Education about the importance of exercise
2. Medical clearance to exercise
3. Negotiation of an exercise plan with stroke survivor, family and carers
4. Problem solution, support and encouragement to take up exercise
5. Monitoring and support of behaviour change
Follow-up will occur at 3 months and 6 months. Adherence to protocol will be documented with each face to face visit.
Intervention code [1] 287801 0
Lifestyle
Intervention code [2] 288335 0
Rehabilitation
Comparator / control treatment
Not applicable - single group feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290322 0
Physical activity levels during waking hours over 1 week using the bodymedia Sensewear armband (amount of physcial activity (mins) and number of steps/day).
Timepoint [1] 290322 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [1] 304304 0
Waist circumference (cm) using a tape measure at the level of the umbilicus.
Timepoint [1] 304304 0
Baseline, post-intervention (3 months), Follow-up (6 months)
Secondary outcome [2] 304305 0
Adverse events: injurious falls, non-injurious falls, muscle soreness and/or fatigue, hospitalisation and/or death will be self-reported by the participant/carer on a daily calendar.
Timepoint [2] 304305 0
Assessed on a daily basis during the 3 month intervention period
Secondary outcome [3] 305659 0
weight (kg) using electronic scales
Timepoint [3] 305659 0
Baseline, post-intervention (3 months), follow-up (6 months)
Secondary outcome [4] 305660 0
Blood pressure (mmHg) using an electronic blood pressure machine
Timepoint [4] 305660 0
Baseline, Post-intervention (3 months), follow-up (6months)
Secondary outcome [5] 305661 0
6 minute walk test (m)
Timepoint [5] 305661 0
Baseline, post-intervention (3 months) and follow-up (6 months)
Secondary outcome [6] 305662 0
10m walk test (speed (m/s); stride length (cm))
Timepoint [6] 305662 0
Baseline, Post-intervention (3 months), follow-up (6 months)
Secondary outcome [7] 305663 0
EuroQOL 5D to measure health state
Timepoint [7] 305663 0
Baseline, Post-intervention (3 months) and follow-up (6 months)
Secondary outcome [8] 305664 0
A modified version of the IPAQ will be used to measure participation restrictions
Timepoint [8] 305664 0
Baseline, Post-intervention (3 months) and follow-up (6 months)
Secondary outcome [9] 305665 0
Self-Efficacy for exercise scale
Timepoint [9] 305665 0
Baseline, Post-intervention (3 months) and follow-up (6 months)
Secondary outcome [10] 305666 0
Feasibility of recruitment through calculation of the number of patients screened, eligible and enrolled.
Timepoint [10] 305666 0
Follow-up (6 months)
Secondary outcome [11] 305667 0
Feasibility of intervention measured via participant adherence with the intervention
Timepoint [11] 305667 0
Post-intervention (3 months)
Secondary outcome [12] 305668 0
Feasibility of the measurement protocol through the time taken to administer
Timepoint [12] 305668 0
Baseline, Post-intervention (3 months) and Follow-up (6 months)

Eligibility
Key inclusion criteria
Patients after 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A score of greater than or 25/30 on Frenchay Screening Aphasia test

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Single group feasiblity study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a feasibility study, so no between group differences will be detected. If the intervention is demonstrated to be feasible, then this study will be used to make a power calculation for a large scale RCT.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 1455 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 7289 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 287841 0
University
Name [1] 287841 0
University of Canberra
Address [1] 287841 0
Discipline of Physiotherapy
Faculty of Health
Building 12
Moana St
Bruce ACT 2617
Country [1] 287841 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Discipline of Physiotherapy
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Ldcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 286568 0
Hospital
Name [1] 286568 0
The Canberra Hospital
Address [1] 286568 0
GPO Box 825
Canberra City ACT 2601
Country [1] 286568 0
Australia
Secondary sponsor category [2] 286569 0
University
Name [2] 286569 0
University of Canberra
Address [2] 286569 0
Discipline of Physiotherapy
Faculty of Health
Building 12
Moana St Bruce
ACT 2617
Country [2] 286569 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289780 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 289780 0
ACT Health
GPO Box 825
Canberra City ACT 2601
Ethics committee country [1] 289780 0
Australia
Date submitted for ethics approval [1] 289780 0
Approval date [1] 289780 0
23/04/2013
Ethics approval number [1] 289780 0
ETHLR.13.063
Ethics committee name [2] 289781 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [2] 289781 0
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Ethics committee country [2] 289781 0
Australia
Date submitted for ethics approval [2] 289781 0
Approval date [2] 289781 0
15/07/2013
Ethics approval number [2] 289781 0
2013.629
Ethics committee name [3] 289782 0
Macquarie University Human Research Ethics Committee
Ethics committee address [3] 289782 0
Macquarie University
Balaclava Road
North Ryde NSW 2109

Ethics committee country [3] 289782 0
Australia
Date submitted for ethics approval [3] 289782 0
Approval date [3] 289782 0
19/06/2013
Ethics approval number [3] 289782 0
5201300469

Summary
Brief summary
To determine the feasibility and efficacy of 3 months of self-management support for increasing physical activity in people with mild disability after stroke
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42398 0
A/Prof Cath Dean
Address 42398 0
Discipline of Physiotherapy
Macquarie University
Ground floor 75 Talavera Road
Ryde NSW 2109
Country 42398 0
Australia
Phone 42398 0
+61 2 9850 6620
Fax 42398 0
Email 42398 0
catherine.dean@mq.edu.au
Contact person for public queries
Name 42399 0
Ms Elisabeth Preston
Address 42399 0
Discipline of Physiotherapy
Faculty of Health
University of Canberra
Moana St Bruce
ACT 2617
Country 42399 0
Australia
Phone 42399 0
+61 2 62015749
Fax 42399 0
Email 42399 0
elisabeth.preston@canberra.edu.au
Contact person for scientific queries
Name 42400 0
A/Prof Cath Dean
Address 42400 0
Discipline of Physiotherapy
Macquarie University
Ground floor 75 Talavera Road
Ryde NSW 2109
Country 42400 0
Australia
Phone 42400 0
+61 2 9850 6620
Fax 42400 0
Email 42400 0
catherine.dean@mq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results